BC 2000: all centres/groups, trials/strata and treatments

Key: Green - ineligible for overview, nonstandard randomisation or otherwise excluded; Blue - data not (yet) received

11 University of Texas M.D. Anderson Cancer Center, U.S.A. {Buzdar, Gutterman, Vassilopoulou-Sellin: APR-2001 (THIRD REVISED VERSION, UPDATED)}

1101 77J1 Study 77-30A (Buzdar): 2-Way; N+; Entry JUN-1977 to JUL-1980 (141 patients were entered)

1 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2yr
2 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide + Bacillus Calmette-Guèrin) × 2yr

1102 77J2 Study 77-30B (Buzdar): 4-Way; Axillary Clearance; N+; Entry MAY-1978 to JUN-1980 (97 patients were entered)

1 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2yr
2 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide + Bacillus Calmette-Guèrin) × 2yr
3 Radiotherapy + (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2yr
4 Radiotherapy + (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide + Bacillus Calmette-Guèrin) × 2yr

1103 80A Study 80-26 (Buzdar): ER+/ER?; N+; Entry MAY-1980 to JAN-1983 (235 patients were entered)

1 (5-Fluoro-Uracil [400mg/m² iv d1,8] + Doxorubicin [40mg/m² iv d1] + Cyclophosphamide [400mg/m² iv d1] + Vincristine [1·5-2mg/m² iv d1] + P [40mg/m² po d1-5] + Tamoxifen [20mg/d po d6-21]) q3wk × 8
2 (5-Fluoro-Uracil [400mg/m² iv d1,8] + Doxorubicin [40mg/m² iv d1] + Cyclophosphamide [400mg/m² iv d1] + Vincristine [1·5-2mg/m² iv d1] + P [40mg/m² po d1-5] + Tamoxifen [20mg/d po d6-21]) q3wk × 8 + (Methotrexate [75mg/m² im/iv d1] q2wk × 6 then Vinblastine [1·7mg/m² iv d1-5] q3wk × 4)

1104 86L1 Study 86-12 (Buzdar): Stage II-III; Age < 50; Entry MAR-1986 to JUL-1994 (516 patients were entered)

1 (Cyclophosphamide [500mg/m² iv d1] + Doxorubicin [50mg/m² iv d1] + 5-Fluoro-Uracil [500mg/m² iv d1,8]) q4wk × 6
2 (Cyclophosphamide [500mg/m² iv d1] + Doxorubicin [50mg/m² iv d1] + 5-Fluoro-Uracil [500mg/m² iv d1,8]) q4wk × 4 then (Methotrexate [75mg/m² iv d1] + Vinblastine [1·7mg/m² iv d1-5] + Folinic Acid [8mg/m² iv d2] q6h × 8) q4wk × 4

1105 86L2 Study 86-12 (Buzdar): Stage II-III; Age 51+; ER-/ER?; Entry MAR-1986 to MAY-1994 (153 patients were entered)

1 (Cyclophosphamide [500mg/m² iv d1] + Doxorubicin [50mg/m² iv d1] + 5-Fluoro-Uracil [500mg/m² iv d1,8]) q4wk × 6
2 (Cyclophosphamide [500mg/m² iv d1] + Doxorubicin [50mg/m² iv d1] + 5-Fluoro-Uracil [500mg/m² iv d1,8]) q4wk × 4 then (Methotrexate [75mg/m² iv d1] + Vinblastine [1·7mg/m² iv d1-5] + Folinic Acid [8mg/m² po d2] q6h × 8) q4wk × 4

1106 86L3 Study 86-12 (Buzdar): Stage II-III; Age 51+; ER+; Entry APR-1986 to APR-1994 (122 patients were entered)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 4 then (Methotrexate + Vinblastine + Folinic Acid) × 4
2 Tamoxifen

1107 Inflammatory Carcinoma (Wiseman): T4 N1-2 M0; Entry 1978 to 1981 (about 40 patients were entered; terminated early; not received)

1 Bacillus Calmette-Guèrin
2 Bacillus Calmette-Guèrin + Tumour Cells

1109 82F Study 82-27 (Buzdar): Stage I; T1-2 N0; Entry APR-1982 to JUN-1988 (131 patients were entered)

1 (5-Fluoro-Uracil [400mg/m² iv d1,8] + Doxorubicin [40mg/m² iv d1] + Cyclophosphamide [400mg/m² iv d1] + Vincristine [1·5mg/m², total 2mg max. iv d1] + Prednisone [total 40mg po d1-5]) q4wk × 4
2 Control

1110 83N1 Study 82-79 (Buzdar): Stage II-III; ER-; Entry FEB-1983 to MAR-1986 (116 patients were entered)

1 (Doxorubicin + Cyclophosphamide) [dose intensive] × 6 + Prednisone + Vincristine
2 (Doxorubicin + Cyclophosphamide) [dose intensive] × 6 + Prednisone + Vincristine + Interferon × 1yr

1111 83N2 Study 82-79 (Buzdar): Stage II-III; ER+/ER?; Entry FEB-1983 to MAR-1986 (195 patients were entered)

1 (Doxorubicin + Cyclophosphamide) [dose intensive] × 6 + Prednisone + Vincristine + Tamoxifen × 1yr
2 (Doxorubicin + Cyclophosphamide) [dose intensive] × 6 + Prednisone + Vincristine + (Interferon + Tamoxifen) × 1yr

1112 Oestrogen Replacement Therapy Trial (Post Treatment for Localised Breast Cancer) (Vassilopoulou-Sellin): Postmenopausal; Entry ? (50 patients were entered by MAR-1995; synthetic data only)

1 Oestrogen Replacement Therapy
2 Control

1113 Tamoxifen Bioequivalence Trial: Entry ? (30 patients were entered; not received)

1 Tamoxifen [10mg bd] × 3m then Tamoxifen [20mg/d] × 3m
2 Tamoxifen [20mg/d] × 3m then Tamoxifen [10mg bd] × 3m

1114 Incomplete Responders to Primary Chemotherapy: Stage II-III; Entry 1985 to 1989 (106 patients were entered; not received)

1 (Cyclophosphamide + Doxorubicin + Vincristine + Prednisone) × 3 then (Cyclophosphamide + Doxorubicin + Vincristine + Prednisone) × 5
2 (Cyclophosphamide + Doxorubicin + Vincristine + Prednisone) × 3 then (Methotrexate + 5-Fluoro-Uracil + Vincristine) × 5

1115 Chemoprevention Trial: Entry ? (not received)

1 Tamoxifen [20mg/d]
2 Fenretinide
3 Fenretinide + Tamoxifen [20mg/d] × 2yr

1116 __E1 Operable Breast Cancer: Randomised after surgery; N10+; Premenopausal; Age < 65; Entry ? (78 patients were entered to 1116-1121; not received)

1 (5-Fluoro-Uracil [500mg/m² d1,4] + Doxorubicin [50mg/m² d1-3] + Cyclophosphamide [500mg/m² d1]) q21d × 8 then Radiotherapy
2 (5-Fluoro-Uracil [500mg/m² d1,4] + Doxorubicin [50mg/m² d1-3] + Cyclophosphamide [500mg/m² d1]) q21d × 8 then (Cyclophosphamide [1750mg/m² qd d1-3] + Etoposide [400mg/m² qd d1-3] + Cis-Platinum [55mg/m² qd d1-3]) × 2 + Autologous Stem Cell Support then Radiotherapy

1117 __E2 Locally Advanced: Randomised after 4 cycles; N4+; Premenopausal; Age < 65; Entry ? (78 patients were entered to 1116-1121; not received)

1 (5-Fluoro-Uracil [500mg/m² d1,4] + Doxorubicin [50mg/m² d1-3] + Cyclophosphamide [500mg/m² d1]) q21d × 8 then Radiotherapy
2 (5-Fluoro-Uracil [500mg/m² d1,4] + Doxorubicin [50mg/m² d1-3] + Cyclophosphamide [500mg/m² d1]) q21d × 8 then (Cyclophosphamide [1750mg/m² qd d1-3] + Etoposide [400mg/m² qd d1-3] + Cis-Platinum [55mg/m² qd d1-3]) × 2 + Autologous Stem Cell Support then Radiotherapy

1118 __E3 Operable Breast Cancer: Randomised after surgery; N10+; Postmenopausal; ER-/ER?; Age < 65; Entry ? (78 patients were entered to 1116-1121; not received)

1 (5-Fluoro-Uracil [500mg/m² d1,4] + Doxorubicin [50mg/m² d1-3] + Cyclophosphamide [500mg/m² d1]) q21d × 8 then Radiotherapy
2 (5-Fluoro-Uracil [500mg/m² d1,4] + Doxorubicin [50mg/m² d1-3] + Cyclophosphamide [500mg/m² d1]) q21d × 8 then (Cyclophosphamide [1750mg/m² qd d1-3] + Etoposide [400mg/m² qd d1-3] + Cis-Platinum [55mg/m² qd d1-3]) × 2 + Autologous Stem Cell Support then Radiotherapy

1119 __E4 Locally Advanced: Randomised after 4 cycles; N4+; Postmenopausal; ER-/ER?; Age < 65; Entry ? (78 patients were entered to 1116-1121; not received)

1 (5-Fluoro-Uracil [500mg/m² d1,4] + Doxorubicin [50mg/m² d1-3] + Cyclophosphamide [500mg/m² d1]) q21d × 8 then Radiotherapy
2 (5-Fluoro-Uracil [500mg/m² d1,4] + Doxorubicin [50mg/m² d1-3] + Cyclophosphamide [500mg/m² d1]) q21d × 8 then (Cyclophosphamide [1750mg/m² qd d1-3] + Etoposide [400mg/m² qd d1-3] + Cis-Platinum [55mg/m² qd d1-3]) × 2 + Autologous Stem Cell Support then Radiotherapy

1120 __E5 Operable Breast Cancer: Randomised after surgery; N10+; Postmenopausal; ER+; Age < 65; Entry ? (78 patients were entered to 1116-1121; not received)

1 (5-Fluoro-Uracil [500mg/m² d1,4] + Doxorubicin [50mg/m² d1-3] + Cyclophosphamide [500mg/m² d1]) q21d × 8 then Radiotherapy then Tamoxifen
2 (5-Fluoro-Uracil [500mg/m² d1,4] + Doxorubicin [50mg/m² d1-3] + Cyclophosphamide [500mg/m² d1]) q21d × 8 then (Cyclophosphamide [1750mg/m² qd d1-3] + Etoposide [400mg/m² qd d1-3] + Cis-Platinum [55mg/m² qd d1-3]) × 2 + Autologous Stem Cell Support then Radiotherapy then Tamoxifen

1121 __E6 Locally Advanced: Randomised after 4 cycles; N4+; Postmenopausal; ER+; Age < 65; Entry ? (78 patients were entered to 1116-1121; not received)

1 (5-Fluoro-Uracil [500mg/m² d1,4] + Doxorubicin [50mg/m² d1-3] + Cyclophosphamide [500mg/m² d1]) q21d × 8 then Radiotherapy then Tamoxifen
2 (5-Fluoro-Uracil [500mg/m² d1,4] + Doxorubicin [50mg/m² d1-3] + Cyclophosphamide [500mg/m² d1]) q21d × 8 then (Cyclophosphamide [1750mg/m² qd d1-3] + Etoposide [400mg/m² qd d1-3] + Cis-Platinum [55mg/m² qd d1-3]) × 2 + Autologous Stem Cell Support then Radiotherapy then Tamoxifen

1122 94B1 Primary Breast Cancer (Buzdar): T1-3 N0-1 M0; Age < 50; Entry MAY-1994 to JUN-1998 (174 patients were entered into 1122-1124; not received)

1 Paclitaxel [250mg/m² 24h infusion] q3wk × 4 preoperative then (5-Fluoro-Uracil [500mg/m² iv d1,4] + Doxorubicin [50mg/m² 72h infusion] + Cyclophosphamide [500mg/m² iv d1]) q3wk × 4 postoperative then Radiotherapy
2 (5-Fluoro-Uracil [500mg/m² iv d1,4] + Doxorubicin [50mg/m² 72h infusion] + Cyclophosphamide [500mg/m² iv d1]) q3wk × 4 preoperative then (5-Fluoro-Uracil [500mg/m² iv d1,4] + Doxorubicin [50mg/m² 72h infusion] + Cyclophosphamide [500mg/m² iv d1]) q3wk × 4 postoperative then Radiotherapy

1123 94B2 Primary Breast Cancer (Buzdar): T1-3 N0-1 M0; Age 50+; ER-/ER?; Entry MAY-1994 to JUN-1998 (174 patients were entered into 1122-1124; not received)

1 Paclitaxel [250mg/m² 24h infusion] q3wk × 4 preoperative then (5-Fluoro-Uracil [500mg/m² iv d1,4] + Doxorubicin [50mg/m² 72h infusion] + Cyclophosphamide [500mg/m² iv d1]) q3wk × 4 postoperative then Radiotherapy
2 (5-Fluoro-Uracil [500mg/m² iv d1,4] + Doxorubicin [50mg/m² 72h infusion] + Cyclophosphamide [500mg/m² iv d1]) q3wk × 4 preoperative then (5-Fluoro-Uracil [500mg/m² iv d1,4] + Doxorubicin [50mg/m² 72h infusion] + Cyclophosphamide [500mg/m² iv d1]) q3wk × 4 postoperative then Radiotherapy

1124 94B3 Primary Breast Cancer (Buzdar): T1-3 N0-1 M0; Age 50+; ER+; Entry MAY-1994 to JUN-1998 (174 patients were entered into 1122-1124; not received)

1 Paclitaxel [250mg/m² 24h infusion] q3wk × 4 preoperative then (5-Fluoro-Uracil [500mg/m² iv d1,4] + Doxorubicin [50mg/m² 72h infusion] + Cyclophosphamide [500mg/m² iv d1]) q3wk × 4 postoperative then Radiotherapy + Tamoxifen × 5yr
2 (5-Fluoro-Uracil [500mg/m² iv d1,4] + Doxorubicin [50mg/m² 72h infusion] + Cyclophosphamide [500mg/m² iv d1]) q3wk × 4 preoperative then (5-Fluoro-Uracil [500mg/m² iv d1,4] + Doxorubicin [50mg/m² 72h infusion] + Cyclophosphamide [500mg/m² iv d1]) q3wk × 4 postoperative then Radiotherapy + Tamoxifen × 5yr

12 Southwest Oncology Group, U.S.A. {Albain, O'Bryan, Osborne: SEP-2001 (FOURTH REVISED VERSION, UPDATED FOUR TIMES)}

1201 79B1 Study 7827 (Osborne): ER+; Postmenopausal; N+; Entry JUL-1979 to MAR-1989 (966 patients were entered)

1 Tamoxifen [10mg bd po] × 1yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + Prednisone) × 1yr
3 Tamoxifen [10mg bd po] × 1yr + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + Prednisone) × 1yr

1202 79B2 Study 7827 (Osborne): ER+; Premenopausal; N+; Entry OCT-1979 to JUL-1989 (314 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + Prednisone) × 1yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + Prednisone) × 1yr + Oöphorectomy

1203 79B3 Study 7827 (Osborne): ER-; N+; Entry JUL-1979 to MAY-1984 (445 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + Prednisone) × 1yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + Prednisone) × 2yr

1204 75A Study 7436 (Osborne): N+; Entry FEB-1975 to FEB-1978 (443 patients were entered)

1 Melphalan × 2yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + Prednisone) × 1yr

1205 80L SWOG 7985 (Osborne): Entry 1980 ff. (28 patients were entered; terminated early; irretrievably lost; not received)

1 Control
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine

1206 84J1 SWOG 8313 (O'Bryan): Mastectomy; N+; ER-; Stage II-III; Entry MAY-1984 to JUN-1990 (578 patients were entered)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + P
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Doxorubicin

1207 84J2 SWOG 8313 (O'Bryan): Lumpectomy; N+; ER-; Stage II-III; Entry JUL-1984 to APR-1990 (50 patients were entered)

1 Cyclophosphamide + 5-Fluoro-Uracil + Radiotherapy then Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + P
2 Cyclophosphamide + 5-Fluoro-Uracil + Radiotherapy then Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Doxorubicin

1208 89B1 SWOG 8814 (Albain, Osborne): Postmenopausal; ER+; N+; 1:4 Randomisation; Entry JUN-1989 to JUL-1995 (1558 patients were entered; actually 1:2:2; Group 3 in Group 2 pro temp.)

1 Tamoxifen × 5yr
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil ± Tamoxifen) × 6 then Tamoxifen × 5yr

1209 ECOG 5188 (Osborne): Premenopausal; ER+; N+; Entry 1989 ff. (duplicated as 7511; not received)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6 then Goserelin × 5yr
3 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6 then (Goserelin + Tamoxifen [20mg/d]) × 5yr

1210 89B2 SWOG 8897 (Osborne): Premenopausal/(Postmenopausal, High Risk); N-; ER-/ER+; Entry JUL-1989 to MAR-1993 (2931 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 then Tamoxifen [20mg/d] × 5yr
4 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6 then Tamoxifen [20mg/d] × 5yr

1211 SWOG 9313 = INT 0137: N0-3; Entry ? (not received)

1 (Doxorubicin + Cyclophosphamide) concurrent
2 Doxorubicin then Cyclophosphamide (sequential)

1212 96B SWOG 9623: N4-9; Entry 1996 ff. (not received)

1 Doxorubicin [80mg/m² iv over 1h d1,15,29] + Paclitaxel [200mg/m² iv over 24h d43,57,71] + Cyclophosphamide [3g/m² iv over 1h d85,99,113] + G-Colony Stimulating Factor
2 Doxorubicin [80mg/m² iv over 1h d1,22,43,64] + Cyclophosphamide [600mg/m² iv over 1h d1,22,43,64] then (Cyclophosphamide [875mg/m² iv over 1h d-6,-5,-4] + Cis-Platinum [55mg/m² iv over 24h d-6,-5,-4] + Carmustine [600mg/m² iv over 2h d-3]) / (Cyclophosphamide [1500mg/m² iv over 24h d-7,-6,-5,-4] + Carboplatin [200mg/m² iv over 24h d-7,-6,-5,-4] + Triethylenephosphoramide [125mg/m² iv over 24h d-7,-6,-5,-4]) then PSBC Support

1213 96C SWOG 9626: Women with symptoms of ovarian failure; Entry 1996 ff. (not received)

1 Megestrol Acetate [20mg/d] × 3m
2 Megestrol Acetate [40mg/d] × 3m
3 Control

1214 96D SWOG 9630: Women treated with tamoxifen; Entry 1996 ff. (not received)

1 Control
2 Medroxyprogesterone Acetate [10mg] q14d × 3m

13 U.K./Asia Collaborative Breast Cancer Trial of CMF/Tamoxifen {Branson, Choy, Collis, Coltart, Cook, Deutsch, Drake, Evans, Halnan, Hanham, Jayatilake, Khoo, Kwong, Mair, Murrell, Pai, Senanayake, Shetty, Sikora, Skeggs, Wilson: MAR-2000 (TENTH REVISION, UPDATED THIRTY-TWO TIMES)}

1301 78E1 Hong Kong (Choy, Khoo, Kwong): N+; Entry AUG-1979 to AUG-1987 (181 patients were entered)

1 Control
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 2yr
3 Tamoxifen [20mg bd] × 2yr
4 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 2yr + Tamoxifen [20mg bd] × 2yr

1302 78E2 Sri Lanka (Jayatilake): N+; Entry JAN-1982 to OCT-1983 (139 patients were entered)

1 Control
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 2yr
3 Tamoxifen [20mg bd] × 2yr
4 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 2yr + Tamoxifen [20mg bd] × 2yr

1303 78E3 Bombay (Pai, Shetty): N+; Entry JAN-1981 to SEP-1983 (50 patients were entered)

1 Control
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 2yr
3 Tamoxifen [20mg bd] × 2yr
4 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 2yr + Tamoxifen [20mg bd] × 2yr

1304 78E4 United Kingdom (Branson, Collis, Coltart, Cook, Deutsch, Drake, Evans, Halnan, Hanham, Mair, Murrell, Senanayake, Sikora, Skeggs, Wilson): N+; Entry MAY-1978 to MAR-1984 (118 patients were entered)

1 Control
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 2yr
3 Tamoxifen [20mg bd] × 2yr
4 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 2yr + Tamoxifen [20mg bd] × 2yr

14 Cancer Research Campaign, London, U.K. {Bates, Baum, Edwards, Fennessy, Houghton, Moritz, Riley: APR-2001 (THIRD REVISED VERSION, UPDATED TEN TIMES)}

1401 80D1 C.R.C. Adjuvant Breast Trial (C.R.C. 2) (Baum): Entry SEP-1980 to APR-1986 (1912 patients were entered)

1 Control
2 Tamoxifen [10mg bd] × 2yr
3 Cyclophosphamide perioperative
4 Tamoxifen [10mg bd] × 2yr + Cyclophosphamide perioperative

1402 70B King's/Cambridge Trial of Post-Operative Radiotherapy (C.R.C. 1) (Baum): Age < 70; Entry MAY-1970 to JUN-1975 (2800 patients were entered)

1 Control
2 Radiotherapy [deep orthovoltage/megavoltage, any site]

1403 76P King's Melphalan Methotrexate Trial (C.R.C. M/M) (Baum): Entry JAN-1976 to DEC-1979 (435 patients were entered)

1 Control
2 (Melphalan + Methotrexate) × 2yr

1404 77H 'Nolvadex' Adjuvant Breast Cancer Trial (N.A.T.O.) (Baum): Entry OCT-1977 to FEB-1981 (1131 patients were entered)

1 Tamoxifen [10mg bd] × 2yr
2 Control

1405 80D2 C.R.C. 2 Parallel Study for Doctors Who Insist on Tamoxifen (Baum): Entry MAY-1984 to FEB-1986 (318 patients were entered)

1 Tamoxifen [10mg bd] × 2yr
2 Cyclophosphamide × 6d perioperative + Tamoxifen [10mg bd] × 2yr

1406 87A C.R.C. Under 50s Trial (part of 'ZIPP') (Baum): Age < 50; Stage I-II; Entry AUG-1987 to MAR-1999 (2710 patients were entered)

1 Control
2 Tamoxifen [20mg/d] × 2yr
3 Goserelin + Tamoxifen [20mg/d] × 2yr
4 Goserelin

1407 84G C.R.C. Elderly Breast Cancer (Bates): Age 71+; Entry JAN-1984 to MAR-1990 (455 patients were entered; 51 have seriously missing information)

1 Optimal Surgery + Tamoxifen [20mg bd]
2 Tamoxifen [20mg bd]

1408 82A C.R.C. Breast Conservation Trial (Baum): Stage I-II; Entry NOV-1982 to APR-1985 (145 patients were entered)

1 Simple Mastectomy + Axillary Sampling + Radiotherapy
2 Tumorectomy + Axillary Sampling + Radiotherapy

1409 86C1 C.R.C. Over 50s Trial (Baum): Excluding Perth Sub-Set; Age 50-75; N-/N+; Entry JAN-1987 to FEB-1997 (3888 patients were entered)

1 Tamoxifen × 2yr
2 Tamoxifen × 5yr

1410 86C2 C.R.C. Parallel Trial of Rôle of Radiotherapy in Patients Receiving Adjuvant Systemic Therapy (Baum): Lumpectomy Sub-Set; Age < 50; Entry SEP-1987 to NOV-1994 (86 patients were entered)

1 Control
2 Prophylactic Radiotherapy according to local practice

1411 86C3 C.R.C. Parallel Trial of Rôle of Radiotherapy in Patients Receiving Adjuvant Systemic Therapy (Baum): Lumpectomy Sub-Set; Age 50+; Entry JAN-1986 to FEB-1995 (434 patients were entered)

1 Control
2 Prophylactic Radiotherapy according to local practice

1412 86C4 C.R.C. Parallel Trial of Rôle of Radiotherapy in Patients Receiving Adjuvant Systemic Therapy (Baum): Mastectomy AXS Sub-Set; Age < 50; Entry FEB-1988 to NOV-1993 (10 patients were entered)

1 Control
2 Prophylactic Radiotherapy according to local practice

1413 86C5 C.R.C. Parallel Trial of Rôle of Radiotherapy in Patients Receiving Adjuvant Systemic Therapy (Baum): Mastectomy AXS Sub-Set; Age 50+; Entry FEB-1986 to JUN-1994 (51 patients were entered)

1 Control
2 Prophylactic Radiotherapy according to local practice

1414 95D ATAC Trial: Invasive Breast Cancer; Optional Elective Chemotherapy; Postmenopausal; Entry 1995 ff. (not received)

1 Tamoxifen
2 Aromatase Inhibitor [1mg/d]
3 Aromatase Inhibitor [1mg/d] + Tamoxifen

1415 86C6 C.R.C. Parallel Trial of Rôle of Radiotherapy in Patients Receiving Adjuvant Systemic Therapy (Baum): Mastectomy AXC Sub-Set; Entry FEB-1986 to AUG-1994 (10 patients were entered)

1 Control
2 Prophylactic Radiotherapy according to local practice

1416 86C7 C.R.C. Over 50s Trial (Baum): Perth Sub-Set; Age 50-75; N-/N+; Entry FEB-1988 to JUN-1994 (89 patients were entered)

1 Tamoxifen × 2yr
2 Tamoxifen × 5yr

15 Christie Hospital and Holt Radium Institute, Manchester, U.K. {Dougal, Paterson, Ribeiro, Russell, Swindell: JUN-2001 (THIRD REVISED VERSION, UPDATED ELEVEN TIMES)}

1501 76F1 Tamoxifen (Ribeiro): Premenopausal; Entry NOV-1976 to MAY-1982 (373 patients were entered)

1 Tamoxifen [10mg bd] × 1yr
2 Ovarian Irradiation

1502 76F2 Tamoxifen (Ribeiro): Postmenopausal; Entry NOV-1976 to JUL-1982 (588 patients were entered)

1 Tamoxifen [10mg bd] × 1yr
2 Control

1503 48A1 Ovarian Irradiation Trial, Part I (Paterson and Russell): Premenopausal; Entry JUN-1948 to DEC-1950 (189 patients were entered)

1 Control
2 Ovarian Irradiation

1504 82J Conservation Trial (Ribeiro): Age < 70; Entry OCT-1982 to DEC-1987 (708 patients were entered)

1 Radiotherapy [8 fractions to tumour bed, single field]
2 Radiotherapy [15 fractions to whole breast, megavoltage]

1505 Manchester Christie Radiotherapy Trial (Paterson): Quadrate; Entry MAR-1949 to AUG-1952 (720 patients were entered; nonstandard randomisation, which used date of birth) {not used in overview}

1 Radiotherapy
2 Control

1506 Manchester Christie Radiotherapy Trial (Paterson): Peripheral; Entry JUN-1952 to JUN-1955 (741 patients were entered; nonstandard randomisation, which used date of birth) {not used in overview}

1 Radiotherapy
2 Control

1507 48A2 Ovarian Irradiation Trial, Part II (Paterson and Russell): Premenopausal; Entry JAN-1951 to JAN-1956 (558 patients were entered; nonstandard randomisation) {not used in overview}

1 Control
2 Ovarian Irradiation

16 U.K. Multicentre Cancer Chemotherapy Study Group, Belfast and London {Reid, Spittle, Vogel, Young: NOV-1995 (UPDATED SIX TIMES)}

1601 77F1 Early Breast Study (Trial 009) 'First Series' (Spittle and Reid): 2:2:1 Randomisation; Entry JUL-1977 to NOV-1979 (193 patients were entered)

1 (Chlorambucil + Methotrexate + 5-Fluoro-Uracil + Vincristine) × 6m
2 (Cyclophosphamide + Vincristine + 5-Fluoro-Uracil/Methotrexate) × 6m
3 Tamoxifen [10mg bd] × 1yr

1602 77F2 Early Breast Study (Trial 009) '9000 Series' 3-Way (Spittle and Reid): 2:2:1 and 1:1:1 Mixed Randomisations; N+; Entry JAN-1979 to OCT-1981 (104 patients were entered)

1 (Chlorambucil + Methotrexate + 5-Fluoro-Uracil + Vincristine) × 6m
2 (Cyclophosphamide + Vincristine + 5-Fluoro-Uracil/Methotrexate) × 6m
3 Tamoxifen [10mg bd] × 1yr

1603 74E Trial 003 (Spittle and Reid): N+; Entry OCT-1974 to AUG-1977 (290 patients were entered)

1 (Cyclophosphamide + Vincristine + 5-Fluoro-Uracil/Methotrexate) × 6m
2 Control

1604 86D1 Chemotherapy (Spittle and Young): Postmenopausal; Age < 70; N+/N?; Entry APR-1986 to SEP-1994 (223 patients were entered)

1 ((Cyclophosphamide + Vincristine + 5-Fluoro-Uracil) / (Cyclophosphamide + Vincristine + Methotrexate)) × 6 alternating + Tamoxifen
2 Tamoxifen

1605 86D2 Chemo-Hormonotherapy versus Radiotherapy-Induced Menopause (Spittle and Young): Premenopausal/Perimenopausal; Age 36+; Entry JAN-1986 to JUN-1994 (153 patients were entered)

1 ((Cyclophosphamide + V + 5-Fluoro-Uracil) / (Cyclophosphamide + V + Methotrexate)) × 6 alternating + Tamoxifen
2 Ovarian Irradiation

1606 77F3 Early Breast Study (Trial 009, Second Randomisation From ChlMFV) 'First Series' (Spittle and Reid): Entry JUL-1977 to NOV-1979 (77 patients were entered)

1 (Chlorambucil + Methotrexate + 5-Fluoro-Uracil + Vincristine) × 6m
2 (Chlorambucil + Methotrexate + 5-Fluoro-Uracil + Vincristine) × 6m then Tamoxifen [10mg bd] × 6m

1607 77F4 Early Breast Study (Trial 009, Second Randomisation from CVF/CVM) 'First Series' (Spittle and Reid): Entry AUG-1977 to NOV-1979 (71 patients were entered)

1 (Cyclophosphamide + Vincristine + 5-Fluoro-Uracil/Methotrexate) × 6m
2 (Cyclophosphamide + Vincristine + 5-Fluoro-Uracil/Methotrexate) × 6m then Tamoxifen [10mg bd] × 6m

1608 77F5 Early Breast Study (Trial 009) 'Second Series' (Spittle and Reid): 2:2:1 Randomisation; Entry SEP-1977 to MAY-1979 (154 patients were entered)

1 (Chlorambucil + Methotrexate + 5-Fluoro-Uracil + Vincristine) × 6m
2 (Cyclophosphamide + Vincristine + 5-Fluoro-Uracil/Methotrexate) × 6m
3 Tamoxifen [10mg bd] × 1yr

1609 77F6 Early Breast Study (Trial 009, Second Randomisation From ChlMFV) 'Second Series' (Spittle and Reid): N+; Entry NOV-1977 to MAY-1979 (60 patients were entered)

1 (Chlorambucil + Methotrexate + 5-Fluoro-Uracil + Vincristine) × 6m
2 (Chlorambucil + Methotrexate + 5-Fluoro-Uracil + Vincristine) × 6m then Tamoxifen [10mg bd] × 6m

1610 77F7 Early Breast Study (Trial 009, Second Randomisation from CVF/CVM) 'Second Series' (Spittle and Reid): N+; Entry OCT-1977 to MAY-1979 (55 patients were entered)

1 (Cyclophosphamide + Vincristine + 5-Fluoro-Uracil/Methotrexate) × 6m
2 (Cyclophosphamide + Vincristine + 5-Fluoro-Uracil/Methotrexate) × 6m then Tamoxifen [10mg bd] × 6m

1611 77F8 Early Breast Study (Trial 009) '3000 Series' 3-Way (Spittle and Reid): N+; Entry JUN-1979 to JUN-1986 (620 patients were entered)

1 (Chlorambucil + Methotrexate + 5-Fluoro-Uracil + Vincristine) × 6m
2 (Cyclophosphamide + Vincristine + 5-Fluoro-Uracil/Methotrexate) × 6m
3 Tamoxifen [10mg bd] × 1yr

18 West Midlands Oncology Association, U.K. {Dunn, Earl, Gray, Hills, Howell, Kelly, Morrison, Poole: AUG-2001 (THIRD REVISED VERSION, UPDATED TWICE)}

1801 76H1 BR3001 (Morrison and Kelly): N+; Entry DEC-1976 to JUL-1984 (568 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + Doxorubicin + Folinic Acid) × 6m
2 Control

1802 76H2 BR3001 (Morrison and Kelly): N-; Entry DEC-1976 to AUG-1984 (575 patients were entered)

1 (Chlorambucil + Methotrexate + 5-Fluoro-Uracil) × 6m
2 Control

1803 85D BR3002 (Morrison and Kelly): Collaborative Trial to Evaluate the Rôle of Radiotherapy and Adjuvant Tamoxifen in the Conservative Management of Breast Cancer; Entry AUG-1985 to DEC-1992 (707 patients were entered)

1 Tamoxifen × 2yr
2 Tamoxifen continuous
3 Radiotherapy [standard] + Tamoxifen × 2yr
4 Radiotherapy [standard] + Tamoxifen continuous
5 Radiotherapy [short] + Tamoxifen × 2yr
6 Radiotherapy [short] + Tamoxifen continuous

1807 91D1 aTTom Trial: Tamoxifen duration controls < 4yr; Entry SEP-1991 ff. (1521 patients were entered by FEB-2000)

1 Tamoxifen × 2-3yr
2 Tamoxifen × 5yr or more

1808 96A NEAT Trial: Entry FEB-1996 ff. (not received)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 4-Epi-Doxorubicin × 4 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4

1809 91D2 aTTom Trial: Tamoxifen duration controls 4+yr; Entry JUL-1991 ff. (2667 patients were entered by FEB-2000)

1 Tamoxifen × 4yr or more
2 Tamoxifen × 5yr or more

1810 98A SECRAB Trial: Entry 1998 ff. (not received)

1 Radiotherapy then Chemotherapy
2 Radiotherapy + Chemotherapy (sandwich)

19 North Sweden Breast Cancer Group, Umeå, Sweden {Bengtsson, Jonsson, Larsson: JUN-2000 (THIRD REVISED VERSION)}

1901 80B1 Trial 1: Age < 55; T0-1; Premenopausal; Entry MAY-1980 to FEB-1987 (97 patients were entered)

1 Control
2 Tamoxifen [20mg bd] × 2yr + Ovarian Irradiation

1902 80B2 Trial 2: Age 55+; T0-1; Postmenopausal; Entry MAY-1980 to JUL-1987 (251 patients were entered)

1 Control
2 Tamoxifen [20mg bd] × 2yr

1903 80B3 Trial 3: High Risk; Age < 55; T3-4; Premenopausal; N+; Entry MAY-1980 to JUN-1987 (70 patients were entered)

1 Control
2 Tamoxifen [20mg bd] × 2yr + Ovarian Irradiation
3 (Doxorubicin + Cyclophosphamide) × 8m
4 Tamoxifen [20mg bd] × 2yr + (Doxorubicin + Cyclophosphamide) × 8m + Ovarian Irradiation

1904 80B4 Trial 4: High Risk; Age 55+; T3-4; Postmenopausal; N+; Entry JUL-1980 to JUL-1987 (117 patients were entered)

1 Control
2 Tamoxifen [20mg bd] × 2yr
3 (Doxorubicin + Cyclophosphamide) × 8m
4 Tamoxifen [20mg bd] × 2yr + (Doxorubicin + Cyclophosphamide) × 8m

1905 Postmenopausal: N+; Entry 1987 ff. (duplicated as 1911; not received)

1 Tamoxifen × 2yr
2 Tamoxifen × 5yr

1906 Premenopausal: N+; Entry 1987 ff. (earlier description of 1908; not received)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 Oöphorectomy + Tamoxifen

1907 Ductal Carcinoma in Situ (DCIS): Conservative Surgery (Quadrantectomy); Entry FEB-1988 to DEC-1999 (98 patients were entered; part of 4406)

1 Control
2 Radiotherapy

1908 89U1 Umeå part of DBCG89b-Umeå-Uppsala-Örebro Trial: Premenopausal; N+; ER+; Entry AUG-1990 to JUN-1997 (45 patients were entered)

1 Oöphorectomy
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 9

1909 89W1 Umeå part of DBCG89d-Umeå-Uppsala-Örebro Trial: Premenopausal; N+; ER-/ER?; Entry AUG-1990 to FEB-1996 (61 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 9
2 (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) × 9
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 9 + Bisphosphonates [300mg/d po] × 4yr
4 (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) × 9 + Bisphosphonates [300mg/d po] × 4yr

1910 NNBC-Study (with Swedish and Finnish centres): Age < 60; pT1-2 N0; 2+ of (ER-; High S-Phase; Tumour > 2cm); Entry post-1990 (not received)

1 Control
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 9

1911 79T3 Umeå part of SESBCG-Örebro-Karlstad Study: Postmenopausal; Stage II; N+; Age < 70; Entry OCT-1987 to DEC-1992 (200 patients were entered)

1 Tamoxifen × 2yr
2 Tamoxifen × 5yr

1912 89W2 Umeå part of DBCG89d-Umeå-Uppsala-Örebro Trial: Premenopausal; N+; ER-/ER?; Entry JUN-1996 to DEC-1996 (6 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 9
2 (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) × 9

1913 89W3 Umeå part of DBCG89d-Umeå-Uppsala-Örebro Trial: Postmenopausal; N+; ER-/ER?; Entry AUG-1992 to MAY-1995 (4 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 9
2 (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) × 9
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 9 + Bisphosphonates [300mg/d po] × 4yr
4 (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) × 9 + Bisphosphonates [300mg/d po] × 4yr

1914 89W4 Umeå part of DBCG89d-Umeå-Uppsala-Örebro Trial: Postmenopausal; N+; ER-/ER?; Entry JUN-1996 to SEP-1997 (5 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 9
2 (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) × 9

20 Stockholm Breast Cancer Study Group, Sweden {Glas, Johansson, Rutqvist, Wallgren: AUG-2001 (THIRD REVISED VERSION, UPDATED TWICE)}

2001 71B Stockholm A: Axillary Clearance; Entry MAR-1971 to OCT-1976 (960 patients were entered)

1 Radiotherapy [megavoltage] preoperative
2 Radiotherapy [megavoltage] postoperative
3 Control

2002 76G1 The Stockholm Adjuvant Tamoxifen Trial: High Risk; 1:1 Randomisation; Postmenopausal; Entry NOV-1976 to MAY-1978 (130 patients were entered)

1 Tamoxifen [20mg bd] × 2yr + Radiotherapy
2 Tamoxifen [20mg bd] × 2yr + (Chlorambucil/Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12
3 (Chlorambucil/Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12
4 Radiotherapy

2003 76G2 The Stockholm Adjuvant Tamoxifen Trial: High Risk; mixed randomisations for radiotherapy vs. chemotherapy; Postmenopausal; Entry MAR-1982 to SEP-1984 (124 patients were entered)

1 Tamoxifen [20mg bd] × 2/5yr + Radiotherapy
2 Tamoxifen [20mg bd] × 2/5yr + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12
4 Radiotherapy

2004 76G3 The Stockholm Adjuvant Tamoxifen Trial: High Risk; Postmenopausal; Entry JAN-1981 to MAY-1990 (279 patients were entered)

1 Tamoxifen [20mg bd] × 2/5yr + Radiotherapy
2 Radiotherapy

2005 76G4 The Stockholm Adjuvant Tamoxifen Trial: Low Risk; Postmenopausal; N-; Entry DEC-1976 to DEC-1979 (283 patients were entered) {Note: no real evidence of imbalance in nodal status: all 4 N+ patients happened to be allocated control}

1 Tamoxifen [20mg bd] × 2yr
2 Control

2006 76G5 The Stockholm Adjuvant Tamoxifen Trial: Breast-Conserving Surgery; Postmenopausal; N-; Entry JAN-1977 to MAY-1980 (35 patients were entered)

1 Tamoxifen [20mg bd] × 2yr + Radiotherapy
2 Radiotherapy

2007 79T4 The Stockholm Adjuvant Tamoxifen Trial (Stockholm part of SESBCG-Örebro-Karlstad Study): (High Risk)/(Low Risk); Randomisation at 2-Year Point; Postmenopausal; Entry JAN-1982 to JUL-1992 (808 patients were entered)

1 Tamoxifen [20mg bd] × 5yr
2 Tamoxifen [20mg bd] × 2yr

2008 90K1 Sto 6: Operable DS; Postmenopausal; Stage I-III; ER?/ER+; pN-; Entry MAY-1990 ff. (not received)

1 Tamoxifen × 2yr
2 (Tamoxifen + Megestrol Acetate sequential) × 2yr

2009 90K2 Sto 6: Operable DS; Postmenopausal; Stage I-III; ER?/ER+; pN+; Entry MAY-1990 ff. (not received)

1 Radiotherapy postoperative + Tamoxifen × 2yr
2 Radiotherapy postoperative + (Tamoxifen + Megestrol Acetate sequential) × 2yr

2010 90L1 Sto 7: Operable DS; Postmenopausal; Stage I-III; ER-; pN-; Entry JUN-1990 to JAN-1996 (248 patients were entered)

1 Tamoxifen [40mg/d] × 2yr
2 Control

2011 90L2 Sto 7: Operable DS; Postmenopausal; Stage I-III; ER-; pN+; Entry JUN-1990 to FEB-1996 (118 patients were entered)

1 Radiotherapy postoperative + Tamoxifen [40mg/d] × 2yr
2 Radiotherapy postoperative

2012 Radiotherapy-Chemotherapy Trial: Premenopausal; Stage II-III; ER-; Entry post-1990 (never activated)

1 Radiotherapy then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 then Radiotherapy

2013 90V1 Sto 5: Operable DS; Premenopausal; Stage I-III; pN-; ER-/ER+; Entry MAY-1990 ff. (700 patients were entered to 2013+2014+2021 by MAY-1994; target 1000; not received)

1 Tamoxifen × 2yr
2 (Tamoxifen + Goserelin) × 2yr
3 Goserelin × 2yr
4 Control

2014 90V2 Sto 5: Operable DS; Premenopausal; Stage I-III; pN1-3; ER-/ER+; Entry MAY-1990 ff. (700 patients were entered to 2013+2014+2021 by MAY-1994; target 1000; not received)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 + Tamoxifen × 2yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 + (Tamoxifen + Goserelin) × 2yr
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 + Goserelin × 2yr
4 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6

2015 76G6 Radiotherapy-Chemotherapy Trial: Premenopausal; Entry OCT-1976 to MAY-1978 (60 patients were entered)

1 Radiotherapy
2 (Chlorambucil/Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12

2016 76G7 Radiotherapy-Chemotherapy Trial: Premenopausal; Entry JUN-1978 to MAY-1990 (487 patients were entered)

1 Radiotherapy
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12

2017 76G8 The Stockholm Adjuvant Tamoxifen Trial: High Risk; 1:1 Randomisation; Postmenopausal; Entry JUN-1978 to DEC-1979 (94 patients were entered)

1 Tamoxifen [20mg bd] × 2yr + Radiotherapy
2 Tamoxifen [20mg bd] × 2yr + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12
4 Radiotherapy

2018 76G9 The Stockholm Adjuvant Tamoxifen Trial: Low Risk; Postmenopausal; N-; Entry JAN-1980 to AUG-1990 (1065 patients were entered) {Note: no real evidence of imbalance in nodal status: all 4 N+ patients happened to be allocated control}

1 Tamoxifen [20mg bd] × 2/5yr
2 Control

2019 76Ga The Stockholm Adjuvant Tamoxifen Trial: Breast-Conserving Surgery; 2/5yr Tamoxifen; Postmenopausal; N-; Entry JUL-1980 to AUG-1990 (397 patients were entered)

1 Tamoxifen [20mg bd] × 2/5yr + Radiotherapy
2 Radiotherapy

2020 76Gb The Stockholm Adjuvant Tamoxifen Trial: High Risk; 1:1 Randomisation; Postmenopausal; Entry (JAN-1980 to FEB-1982)/(OCT-1984 to MAY-1990) (331 patients were entered)

1 Tamoxifen [20mg bd] × 2/5yr + Radiotherapy
2 Tamoxifen [20mg bd] × 2/5yr + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12
4 Radiotherapy

2021 90V3 Sto 5: Operable DS; Premenopausal; Stage I-III; pN4+; ER-/ER+; Entry MAY-1990 ff. (700 patients were entered to 2013+2014+2021 by MAY-1994; target 1000; not received)

1 Radiotherapy postoperative + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 + Tamoxifen × 2yr
2 Radiotherapy postoperative + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 + (Tamoxifen + Goserelin) × 2yr
3 Radiotherapy postoperative + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 + Goserelin × 2yr
4 Radiotherapy postoperative + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6

2022 Sto 8: DCIS; Premenopausal/Postmenopausal; Breast-Conserving Surgery; Entry MAY-1990 to DEC-1999 (188 patients were entered)

1 Radiotherapy [50Gy to breast]
2 Control

2023 Sto 9: Invasive Breast Cancer; High Risk; Age < 60; pN6+/(pN4+, bad biological profile); Entry 1990 ff. (duplicates 21603; not received)

1 Chemotherapy [high dose] + Autologous Bone Marrow Transplant
2 (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) [dose-escalated] × 6

21 Toronto-Edmonton Clinical Trials Group, Canada {DeBoer, Hao, Pritchard: JUN-2000 (THIRD REVISED VERSION)}

2101 78B1 T.E.C.T.G. Trial II of Adjuvant Tamoxifen (Hao): Postmenopausal; N+; Entry JAN-1978 to APR-1984 (400 patients were entered)

1 Control
2 Tamoxifen [10mg tds] × 2yr

2102 78B2 T.E.C.T.G. Trial of Radiation Ovarian Ablation and Prednisone (6-way) (DeBoer): Premenopausal; N+; Entry JAN-1978 to JUN-1980 (74 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr
2 Ovarian Irradiation + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr + Prednisone × 5yr
3 Ovarian Irradiation + Radiotherapy [regional] + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr + Prednisone × 5yr
4 Bacillus Calmette-Guèrin + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr
5 Ovarian Irradiation + Bacillus Calmette-Guèrin + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr + Prednisone × 5yr
6 Ovarian Irradiation + Radiotherapy [regional] + Bacillus Calmette-Guèrin + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr + Prednisone × 5yr

2104 78B3 T.E.C.T.G. Trial of Radiation Ovarian Ablation and Prednisone (2-way) (DeBoer): Premenopausal; N+; Entry JUL-1980 to AUG-1988 (251 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr
2 Ovarian Irradiation + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr + Prednisone × 5yr

22 Danish Breast Cancer Coöperative Group {Andersen, Fischerman, Mouridsen, Rose: JUL-2001 (SECOND REVISED VERSION, UPDATED)}

2201 77B1 DBCG 77b 4-Way: Premenopausal; Entry NOV-1977 to APR-1980 (464 patients were entered)

1 Radiotherapy
2 Radiotherapy + Levamisole
3 Radiotherapy + Cyclophosphamide × 1yr
4 Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr

2202 77B2 DBCG 77b 3-Way: Premenopausal; Entry DEC-1979 to SEP-1981 (247 patients were entered)

1 Radiotherapy
2 Radiotherapy + Cyclophosphamide × 1yr
3 Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr

2203 77B3 DBCG 77b 2-Way: Premenopausal; Entry JAN-1981 to DEC-1982 (503 patients were entered)

1 Radiotherapy + Cyclophosphamide × 1yr
2 Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr

2204 77C1 DBCG 77c 3-Way: Postmenopausal; Entry OCT-1977 to JUL-1980 (744 patients were entered)

1 Radiotherapy
2 Radiotherapy + Levamisole
3 Radiotherapy + Tamoxifen [10mg tds] × 1yr

2205 77C2 DBCG 77c 2-Way: Postmenopausal; Entry DEC-1979 to DEC-1982 (1340 patients were entered; includes JAN-1981 and FEB-1981 during which some centres temporarily deleted group 1 - imbalance 27:57 in that period)

1 Radiotherapy
2 Radiotherapy + Tamoxifen [10mg tds] × 1yr

2206 82B1 DBCG 82b 3-Way: Axillary Biopsy; Premenopausal; Entry SEP-1982 to SEP-1986 (1046 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 9m + Radiotherapy
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 9m
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 9m + Tamoxifen [10mg tds] × 1yr

2207 82C DBCG 82c: Axillary Biopsy; Postmenopausal; Entry OCT-1982 to MAR-1990 (2171 patients were entered)

1 Tamoxifen [10mg tds] × 1yr + Radiotherapy
2 Tamoxifen [10mg tds] × 1yr
3 Tamoxifen [10mg tds] × 1yr + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 9m

2208 83J1 DBCG 82TM, Low Risk: Age < 70; Entry JAN-1983 to MAR-1989 (578 patients were entered)

1 Mastectomy
2 Tumorectomy + Radiotherapy

2209 83J2 DBCG 82TM, High Risk: Premenopausal; Axillary Clearance; Age < 70; Entry MAR-1983 to MAR-1989 (174 patients were entered)

1 Mastectomy + Radiotherapy + Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 Tumorectomy + Radiotherapy + Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

2210 83J3 DBCG 82TM, High Risk: Postmenopausal; Axillary Clearance; Age < 70; Entry MAR-1983 to MAR-1989 (109 patients were entered)

1 Mastectomy + Radiotherapy + Tamoxifen
2 Tumorectomy + Radiotherapy + Tamoxifen

2211 82B2 DBCG 82b 2-Way: Premenopausal; Entry NOV-1983 to FEB-1990 (1102 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 9m + Radiotherapy
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 9m

2212 89U2 DBCG 89b (DBCG part of DBCG89b-Umeå-Uppsala-Örebro Trial): N+; Premenopausal; ER+; Entry DEC-1989 to MAY-1998 (531 patients were entered)

1 (Cyclophosphamide [200mg/m²/wk iv d1] + Methotrexate [13mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9
2 Oöphorectomy

2213 89P1 DBCG 89c (3-Way): N+; Postmenopausal; ER+/ER?; Entry NOV-1989 to AUG-1997 (1648 patients were entered)

1 Tamoxifen × 1yr
2 Tamoxifen × 2yr
3 Tamoxifen × 6m then Megestrol Acetate × 6m

2214 89W5 DBCG 89d (DBCG part of DBCG89d-Umeå-Uppsala-Örebro Trial), 4-Way: N+; Premenopausal; ER-/ER?; Entry DEC-1989 to FEB-1996 (306 patients were entered by AUG-1995)

1 (Cyclophosphamide [200mg/m²/wk iv d1] + Methotrexate [13mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9
2 (Cyclophosphamide [200mg/m²/wk iv d1] + 4-Epi-Doxorubicin [20mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9
3 (Cyclophosphamide [200mg/m²/wk iv d1] + Methotrexate [13mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9 + Pamidronate [300mg/d po] × 4yr
4 (Cyclophosphamide [200mg/m²/wk iv d1] + 4-Epi-Doxorubicin [20mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9 + Pamidronate [300mg/d po] × 4yr

2215 89W6 DBCG 89d (DBCG part of DBCG89d-Umeå-Uppsala-Örebro Trial), 4-Way: N+; Postmenopausal; ER-; Entry FEB-1990 to JAN-1996 (318 patients were entered)

1 (Cyclophosphamide [200mg/m²/wk iv d1] + Methotrexate [13mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9
2 (Cyclophosphamide [200mg/m²/wk iv d1] + 4-Epi-Doxorubicin [20mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9
3 (Cyclophosphamide [200mg/m²/wk iv d1] + Methotrexate [13mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9 + Pamidronate [300mg/d po] × 4yr
4 (Cyclophosphamide [200mg/m²/wk iv d1] + 4-Epi-Doxorubicin [20mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9 + Pamidronate [300mg/d po] × 4yr

2216 89W7 DBCG 89d (DBCG part of DBCG89d-Umeå-Uppsala-Örebro Trial), 4-Way: N-; Premenopausal; Entry JAN-1990 to JAN-1996 (268 patients were entered)

1 (Cyclophosphamide [200mg/m²/wk iv d1] + Methotrexate [13mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9
2 (Cyclophosphamide [200mg/m²/wk iv d1] + 4-Epi-Doxorubicin [20mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9
3 (Cyclophosphamide [200mg/m²/wk iv d1] + Methotrexate [13mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9 + Pamidronate [300mg/d po] × 4yr
4 (Cyclophosphamide [200mg/m²/wk iv d1] + 4-Epi-Doxorubicin [20mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9 + Pamidronate [300mg/d po] × 4yr

2217 Bone Density Trial: Low Risk; Postmenopausal; Age < 66; Bone Density Endpoint; Entry 1992 ff. (50 patients were entered; not received)

1 Tamoxifen [30mg/d] × 2yr
2 Control

2218 89W8 DBCG 89d (DBCG part of DBCG89d-Umeå-Uppsala-Örebro Trial): N+; Premenopausal; ER-/ER?; Entry FEB-1996 to MAY-1998 (41 patients were entered)

1 (Cyclophosphamide [200mg/m²/wk iv d1] + Methotrexate [13mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9
2 (Cyclophosphamide [200mg/m²/wk iv d1] + 4-Epi-Doxorubicin [20mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9

2219 89W9 DBCG 89d (DBCG part of DBCG89d-Umeå-Uppsala-Örebro Trial): N+; Postmenopausal; ER-; Entry MAR-1996 to MAY-1998 (67 patients were entered)

1 (Cyclophosphamide [200mg/m²/wk iv d1] + Methotrexate [13mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9
2 (Cyclophosphamide [200mg/m²/wk iv d1] + 4-Epi-Doxorubicin [20mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9

2220 89Wa DBCG 89d (DBCG part of DBCG89d-Umeå-Uppsala-Örebro Trial): N-; Premenopausal; Entry APR-1996 to APR-1998 (81 patients were entered)

1 (Cyclophosphamide [200mg/m²/wk iv d1] + Methotrexate [13mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9
2 (Cyclophosphamide [200mg/m²/wk iv d1] + 4-Epi-Doxorubicin [20mg/m²/wk iv d1] + 5-Fluoro-Uracil [200mg/m²/wk iv d1]) q3wk × 9

2221 89P2 DBCG 89c (2-Way): N+; Postmenopausal; ER+/ER?; Entry OCT-1990 to NOV-1996 (673 patients were entered)

1 Tamoxifen × 1yr
2 Tamoxifen × 2yr

23 Toulouse Centre Claudius Regaud, France {Hill, Mihura, Naja: SEP-2000 (SECOND REVISED VERSION, UPDATED THRICE)}

2301 80E1 Toulouse Tamoxifen Trial: N0; Postmenopausal; Entry JAN-1981 to JUL-1983 (93 patients were entered) {note: the large difference in nodal status (N4+: 53 T, 18 C, in contrast with N0: 27 T, 63 C) has been extensively investigated without evidence of bias}

1 Control
2 Tamoxifen [30mg/d] × 2yr

2302 80E2 Toulouse Tamoxifen Trial: N1-3; Postmenopausal; Entry JAN-1981 to AUG-1983 (87 patients were entered) {note: the large difference in nodal status (N4+: 53 T, 18 C, in contrast with N0: 27 T, 63 C) has been extensively investigated without evidence of bias}

1 Control
2 Tamoxifen [30mg/d] × 2yr

2303 80E3 Toulouse Tamoxifen Trial: N4+; Postmenopausal; Entry DEC-1980 to AUG-1983 (71 patients were entered) {note: the large difference in nodal status (N4+: 53 T, 18 C, in contrast with N0: 27 T, 63 C) has been extensively investigated without evidence of bias}

1 Control
2 Tamoxifen [30mg/d] × 2yr

2304 83E Toulouse-Montpellier Adjuvant Trial: Premenopausal; N+; ER+; PR+; Entry DEC-1983 to DEC-1989 (153 patients were entered)

1 Radiotherapy + (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 6
2 Oöphorectomy + Radiotherapy + Tamoxifen

25 Milwaukee, U.S.A. {Donegan: JUL-1985}

2501 Extended ThioTepa Adjuvant Trial: Entry JUL-1963 to JUN-1973 (182 patients were entered; nonstandard randomisation; 1985 overview data only) {Do not use until randomisation has been clarified}

1 Triethylenephosphoramide × 1yr
2 Control

26 Austrian Breast Cancer Study Group {Gnant, Jakesz, Mittelböck: APR-2000 (THIRD REVISED VERSION)}

2601 77G1 Vienna Postoperative Chemotherapy Trial (Jakesz): Axillary Clearance; Entry SEP-1977 to JUN-1982 (241 patients were entered)

1 Control
2 (Cyclophosphamide [100mg po d1-10] + Methotrexate [total 25mg iv d1,8] + 5-Fluoro-Uracil [total 750mg iv d1,8] + Vinblastine [total 5mg iv d1,8]) q3m (y1); q6m (y2-3) × 3yr
3 (Cyclophosphamide [100mg po d1-10] + Methotrexate [total 25mg iv d1,8] + 5-Fluoro-Uracil [total 750mg iv d1,8] + Vinblastine [total 5mg iv d1,8]) q3m (y1); q6m (y2-3) × 3yr + Azimexon

2602 84Q1 ABCSG Trial 1 (Jakesz): ER-; PR-; pN0; Premenopausal/Postmenopausal; Entry JUL-1984 to SEP-1991 (307 patients were entered; 30 ineligibles missing)

1 Control
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1 + (Doxorubicin + Vincristine) [d1,21,28] (short-term)

2603 84Q2 ABCSG Trial 3 (Jakesz): ER-; PR-; pN+; Premenopausal/Postmenopausal; Entry JUL-1984 to SEP-1991 (263 patients were entered; 18 ineligibles missing)

1 (Cyclophosphamide [total 500mg d1,8] + Methotrexate [total 25mg d1,8] + 5-Fluoro-Uracil [total 1000mg d1,8]) q28d × 6
2 (Cyclophosphamide [total 500mg d1,8] + Methotrexate [total 25mg d1,8] + 5-Fluoro-Uracil [total 1000mg d1,8] + Doxorubicin [50mg/m² d1] + Vinblastine [5mg/m² d1]) q28d × 6

2604 84Q3 ABCSG Trial 2 (Jakesz): ER+/PR+; pN+; Premenopausal; Entry OCT-1984 to NOV-1990 (260 patients were entered; 2 ineligibles missing)

1 Tamoxifen [20mg/d] × 2yr
2 Tamoxifen [20mg/d] × 2yr + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1 + (Doxorubicin + Vincristine) [d1,21,28] (short-term)

2605 84Q4 ABCSG Trial 4, 3-Way (Jakesz): ER+/PR+; pN+; Postmenopausal; Entry SEP-1984 to JAN-1989 (225 patients were entered; 15 additional ineligibles missing from 2605+2606)

1 Control
2 Tamoxifen [20mg/d] × 2yr
3 Tamoxifen [20mg/d] × 2yr + (Cyclophosphamide [total 500mg d21,28] + Methotrexate [total 25mg d21,28] + 5-Fluoro-Uracil [total 1000mg d21,28] + Doxorubicin [30mg/m² d1] + Vinblastine [5mg/m² d1])

2606 84Q5 ABCSG Trial 4, 2-Way (Jakesz): ER+/PR+; pN+; Postmenopausal; Entry FEB-1989 to NOV-1990 (113 patients were entered; 15 additional ineligibles missing from 2605+2606)

1 Tamoxifen [20mg/d] × 2yr
2 Tamoxifen [20mg/d] × 2yr + (Cyclophosphamide [total 500mg d21,28] + Methotrexate [total 25mg d21,28] + 5-Fluoro-Uracil [total 1000mg d21,28] + Doxorubicin [30mg/m² d1] + Vinblastine [5mg/m² d1])

2607 90W1 ABCSG Study V: Premenopausal; N-/N+; ER-/ER+; Entry DEC-1990 to JUN-1999 (1099 patients were entered)

1 Goserelin [3·6mg] q28d × 3yr + Tamoxifen [20mg/d] × 5yr
2 (Cyclophosphamide [600mg/m² d1,8] + Methotrexate [60mg/m² d1,8] + 5-Fluoro-Uracil [600mg/m² d1,8]) × 6

2608 90W1 ABCSG Study VI: Postmenopausal; N-/N+; ER+/PR+; Entry DEC-1990 to DEC-1995 (2019 patients were entered)

1 (Aminoglutethimide [500mg] + Tamoxifen [40mg/d]) × 2yr + Tamoxifen [20mg/d] × 2yr
2 Tamoxifen [40mg/d] × 2yr + Tamoxifen [20mg/d] × 2yr

2609 90W1 ABCSG Study VIa (Second Randomisation from 2608 at 5yr): Postmenopausal; N-/N+; ER+/PR+; Entry 1995 ff. (not received)

1 Anastrozole [1mg/d] × 3yr
2 Control

2610 90W1 ABCSG Trial VIII (Second Randomisation after 2yr tamoxifen [20mg/d]): "Hormone Responsive"; G1/G2; Stage I-II; Postmenopausal; N-/N+; ER+/PR+; Entry JAN-1996 ff. (not received)

1 Anastrozole × 3yr
2 Tamoxifen × 3yr

2611 91A1 ABCSG Study VII: "Hormono Receptor Negative"; Stage I-II; N-/N?; Entry NOV-1991 to OCT-1999 (242 patients were entered)

1 (Cyclophosphamide [600mg/m² d1,8] + Methotrexate [40mg/m² d1,8] + 5-Fluoro-Uracil [600mg/m² d1,8]) × 3 preoperative then (Cyclophosphamide [600mg/m² d1,8] + Methotrexate [40mg/m² d1,8] + 5-Fluoro-Uracil [600mg/m² d1,8]) × 3 postoperative
2 (Cyclophosphamide [600mg/m² d1,8] + Methotrexate [40mg/m² d1,8] + 5-Fluoro-Uracil [600mg/m² d1,8]) × 6 postoperative

2612 91A2 ABCSG Study VII: "Hormono Receptor Negative"; Stage I-II; N+; Entry NOV-1991 to MAY-1999 (181 patients were entered)

1 (Cyclophosphamide [600mg/m² d1,8] + Methotrexate [40mg/m² d1,8] + 5-Fluoro-Uracil [600mg/m² d1,8]) × 3 preoperative then (4-Epi-Doxorubicin [70mg/m² d1] + Cyclophosphamide [600mg/m² d1]) × 3 postoperative
2 (Cyclophosphamide [600mg/m² d1,8] + Methotrexate [40mg/m² d1,8] + 5-Fluoro-Uracil [600mg/m² d1,8]) × 3 postoperative then (4-Epi-Doxorubicin [70mg/m² d1] + Cyclophosphamide [600mg/m² d1]) × 3

2613 96E ABCG Study IX: "Hormone Responsive"; Stage I-II; G3; Undifferentiated; Entry 1996 ff. (23 patients were entered by 1997; not received)

1 Tamoxifen [20mg/d] × 5yr
2 Tamoxifen [20mg/d] × 5yr + (5-Fluoro-Uracil [600mg/m²] + 4-Epi-Doxorubicin [60mg/m²] + Cyclophosphamide [600mg/m²]) q3wk × 4

2614 77G2 Vienna Postoperative Chemotherapy Trial, Surgery (Jakesz): Axillary Clearance; N-; Entry SEP-1977 ff. (65 patients were entered)

1 Partial Mastectomy
2 Modified Radical Mastectomy

2615 77G3 Vienna Postoperative Chemotherapy Trial, Surgery (Jakesz): Axillary Clearance; N+; Entry SEP-1977 ff. (77 patients were entered)

1 Modified Radical Mastectomy
2 Halsted Mastectomy

27 London Guy's Hospital, U.K. {Fentiman, Hayward, Rubens, Smith: JUN-2000 (REVISED VERSION, UPDATED THRICE)}

2701 64C Testosterone versus Nil (Rubens and Fentiman): Premenopausal; Entry MAR-1964 to JUL-1978 (149 patients were entered)

1 Control
2 Testosterone [1mg/d implant] × 3yr

2702 Dehydroepiandrosterone versus Nil (Hayward): Entry ? (3 patients were entered; terminated early; not received)

1 Control
2 Dehydroepiandrosterone

2703 Trial C10 (Quality of Life) Iridium Implant and Surgery (Rubens and Fentiman): Entry NOV-1981 to FEB-1989 (441 patients were entered; part of E.O.R.T.C. 10801 - 'on ice')

1 Modified Radical Mastectomy
2 Tumorectomy + Axillary Clearance + Iridium [implant]

2704 61E1 Surgery I (Rubens and Fentiman): Age 51+; Entry OCT-1961 to MAY-1971 (375 patients were entered)

1 Wide Excision + Radiotherapy
2 Radical Mastectomy + Radiotherapy

2705 61E2 Surgery II (Rubens and Fentiman): N0-1a; Entry MAY-1971 to DEC-1974 (255 patients were entered)

1 Wide Excision + Radiotherapy
2 Radical Mastectomy + Radiotherapy

2706 Guy's and NKI Trial (Bartelink, Fentiman): Frail Patients with Early Breast Cancer; Tumorectomy; Entry 199? ff. (not received)

1 Tamoxifen [20mg/d]
2 Radiotherapy [8Gy] × 3

2707 Iridium Implants (Fentiman): Early Breast Cancer, < 4cm Diameter Tumours; Tumorectomy + Axillary Clearance; Entry 199? ff. (never started; not received)

1 Iridium [20Gy implant] + Radiotherapy [45Gy external]
2 Iridium [45Gy implant]

28 Montpellier, France {Dubois, Hill, Serrou: AUG-2000 (REVISED VERSION, UPDATED FOUR TIMES)}

2801 81A Tamoxifen versus Nil (Dubois): Postmenopausal; Entry FEB-1981 to MAY-1984 (203 patients were entered)

1 Tamoxifen [10mg tds] × 2yr
2 Control

2802 77W1 Immunotherapy (Serrou): T1-3 N0-1b; Entry ?1977 ff. (140 patients were entered; not received; lost, possibly retrievable)

1 Radiotherapy + Bacillus Calmette-Guèrin
2 Radiotherapy

2803 77W2 Chemotherapy and Immunotherapy (Serrou): T3-4; N-/N+; Entry ?1977 ff. (82 patients were entered; not received; lost, possibly retrievable)

1 Control
2 (Cyclophosphamide + Vincristine + 5-Fluoro-Uracil) × 1yr
3 Bacillus Calmette-Guèrin × 1yr

2804 86E Post-Mastectomy (Dubois): N+; ER+; PR+; Premenopausal/Postmenopausal; Age < 75; Entry SEP-1986 ff. (not received)

1 Tamoxifen
2 5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide

29 Swiss Group for Clinical Cancer Research (S.A.K.K.) and O.S.A.K.O. {Castiglione, Senn, Thürlimann: JUN-2000 (SECOND REVISED VERSION)}

2901 74K OSAKO 06/74 Study (Senn and Castiglione): Entry JAN-1974 to DEC-1977 (254 patients were entered; 14 missing)

1 Control
2 (Chlorambucil + Methotrexate + 5-Fluoro-Uracil) × 6 + Bacillus Calmette-Guèrin × 2yr

2902 75L SAKK 27/76 Study (Senn and Castiglione): N+; Entry DEC-1975 to SEP-1978 (421 patients were entered) {note: age imbalance is slight and has no effect in the stratified overview analyses}

1 (Chlorambucil + Methotrexate + 5-Fluoro-Uracil) × 6m
2 (Chlorambucil + Methotrexate + 5-Fluoro-Uracil) × 24m

2903 81R SAKK 27/82 Study (Senn and Castiglione): Entry NOV-1981 to SEP-1986 (248 patients were entered)

1 (Chlorambucil + Methotrexate + 5-Fluoro-Uracil) × 6m
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m

30 South-East Sweden Breast Cancer Group {Dufmats, Hatschek, Nordenskjöld: JUN-2000 (SECOND REVISED VERSION)}

3001 80C1 Adjuvant Chemotherapy: Premenopausal; N+; Stage II; Entry SEP-1980 to MAY-1983 (43 patients were entered)

1 Radiotherapy + (Doxorubicin + Cyclophosphamide) × 6m
2 Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m

3002 80C2 Adjuvant Chemotherapy: Postmenopausal; N+; Age < 66; Stage II; Entry SEP-1980 to FEB-1983 (43 patients were entered)

1 Radiotherapy
2 Radiotherapy + (Doxorubicin + Cyclophosphamide) × 6m

3003 79T1 Adjuvant Treatment with Tamoxifen (part of SESBCG part of SESBCG-Örebro-Karlstad Study, local version): Postmenopausal; Age 51+; Pathological Stage I; T1 N0 M0; ER+; Entry DEC-1984 to DEC-1994 (521 patients were entered)

1 Tamoxifen × 2yr
2 Tamoxifen × 5yr

3004 79T2 Adjuvant Treatment with Tamoxifen A (part of SESBCG part of SESBCG-Örebro-Karlstad Study, local version): Postmenopausal; Stage II; T1-2 N0-1 M0; Entry JUN-1985 to DEC-1994 (1118 patients were entered)

1 Tamoxifen × 2yr
2 Tamoxifen × 5yr

3005 87B Adjuvant Treatment with Tamoxifen B: Premenopausal; Stage II; T1-2 N0-1 M0; ER+; Entry SEP-1989 to AUG-1991 (40 patients were entered)

1 Control
2 Tamoxifen
3 Goserelin
4 Tamoxifen + Goserelin

3006 84U Tamoxifen Trial: Stage II; (Tumour > 2cm)/(Node Metastases); Age < 50; Entry JUL-1984 to OCT-1989 (114 patients were entered)

1 Control
2 Tamoxifen [40mg/d] × 2yr

3007 79T3 Umeå part of SESBCG-Örebro-Karlstad Study (central version): Postmenopausal; Stage II; N+; Age < 70; Entry SEP-1989 to DEC-1994 (168 patients were entered)

1 Tamoxifen × 2yr
2 Tamoxifen × 5yr

3008 79T4 Stockholm part of SESBCG-Örebro-Karlstad Study (central version): (High Risk)/(Low Risk); Randomisation at 2-Year Point; Postmenopausal; Entry NOV-1981 to JUN-1992 (796 patients were entered)

1 Tamoxifen [20mg bd] × 2yr
2 Tamoxifen [20mg bd] × 5yr

3009 79T5 SSBCG part of SESBCG-Örebro-Karlstad Study (central version): Postmenopausal; Entry MAR-1987 to DEC-1994 (1152 patients were entered)

1 Tamoxifen [20mg/d] × 2yr
2 Tamoxifen [20mg/d] × 5yr

3010 79T6 Uppsala-Örebro part of SESBCG-Örebro-Karlstad Study (central version): Postmenopausal; Entry MAY-1987 to DEC-1994 (531 patients were entered)

1 Tamoxifen × 2yr
2 Tamoxifen × 5yr

3011 79T1 Part of SESBCG part of SESBCG-Örebro-Karlstad Study (central version): Postmenopausal; Age 51+; Pathological Stage I; T1 N0 M0; ER+; Entry DEC-1984 to DEC-1994 (506 patients were entered)

1 Tamoxifen × 2yr
2 Tamoxifen × 5yr

3012 79T2 Part of SESBCG part of SESBCG-Örebro-Karlstad Study (central version): Postmenopausal; Stage II; T1-2 N0-1 M0; Entry JUN-1985 to DEC-1994 (1030 patients were entered)

1 Tamoxifen × 2yr
2 Tamoxifen × 5yr

31 Gruppo Ricerca Ormono Chemio Terapia Adiuvante, Genova, Italy {Boccardo: JUN-2000 (SECOND REVISED VERSION)}

3101 83B G.R.O.C.T.A. I: ER+; N+; Stage II; Entry NOV-1983 to SEP-1987 (510 patients were entered)

1 Tamoxifen [10mg tds] × 5yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 then 4-Epi-Doxorubicin × 4
3 Tamoxifen [10mg tds] × 5yr + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 then 4-Epi-Doxorubicin × 4

3102 89E1 G.R.O.C.T.A. II: ER+; N+; Premenopausal; Entry JAN-1989 to MAY-1991 (91 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 Goserelin q1m + Tamoxifen [10mg tds] × 5yr

3103 89E2 G.R.O.C.T.A. III: ER-; N+; Premenopausal; Entry JAN-1989 to JUN-1991 (70 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 ((Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) then (4-Epi-Doxorubicin + Vincristine) then (Mitomycin-C + Vindesine)) × 2

3104 89E3 G.R.O.C.T.A. IV: ER+; N+; Postmenopausal; Entry 1991 ff. (closed early; not received)

1 Tamoxifen [10mg tds] × 2yr
2 Tamoxifen [10mg tds] × 5yr

3105 89E4 G.R.O.C.T.A. V: ER-; N+; Postmenopausal; Entry JAN-1989 to JUN-1991 (45 patients were entered)

1 Tamoxifen [10mg tds] × 3yr + (Cyclophosphamide [600mg/m² os d1-14] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q28d × 6
2 Tamoxifen [10mg tds] × 3yr

3106 89E5 G.R.O.C.T.A. V: Second Randomisation; ER-; N+; Postmenopausal; Entry 1991 ff. (not received)

1 Tamoxifen [10mg tds] × 3yr then Aminoglutethimide [250mg/d] × 2yr
2 Tamoxifen [10mg tds] × 5yr

3107 89E6 G.R.O.C.T.A. IVbis: ER+; Postmenopausal; Entry SEP-1992 to OCT-1998 (380 patients were entered)

1 Tamoxifen × 5yr
2 Tamoxifen × 3yr then Aminoglutethimide [low dose] × 2yr

3108 89E7 G.R.O.C.T.A. II: ER+; (N-, High Risk)/N+; Premenopausal; Entry MAY-1991 to JAN-1997 (153 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 Goserelin q1m × 2yr + Tamoxifen [10mg tds] × 5yr

3109 89E8 G.R.O.C.T.A. III: ER-; (N-, High Risk)/N+; Premenopausal; Entry JUL-1991 to JUN-1992 (37 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 ((Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) then (4-Epi-Doxorubicin + Vincristine) then (Mitomycin-C + Vindesine)) × 2

3110 89E9 G.R.O.C.T.A. V: ER-; (N-, High Risk)/N+; Postmenopausal; Entry JUL-1991 to JUN-1992 (34 patients were entered)

1 Tamoxifen [10mg tds] × 3yr + (Cyclophosphamide [600mg/m² os d1-14] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q28d × 6
2 Tamoxifen [10mg tds] × 3yr

33 Caen Centre Regional Francois Baclesse, France {Delozier: JUN-2000 (SECOND REVISED VERSION)}

3301 78F Essai Tamoxifene C5: Postmenopausal; N+; Entry MAY-1978 to MAR-1982 (179 patients were entered)

1 Control
2 Tamoxifen [20mg bd] × 3yr

3302 71A Ovarian Irradiation Trial: Postmenopausal; T1-3 N+ M0; Entry JAN-1971 to MAR-1976 (52 patients were entered)

1 Ovarian Irradiation
2 Control

3303 86M1 FNCLCC Groupe Sein Protocole TAM 001 - Essai Therapeutique Nolvadex: 2 Ans / À Vie; Postmenopausal; Entry SEP-1986 to DEC-1996 (3793 patients were entered, 36 missing)

1 Tamoxifen [20-40mg/d] × 2-3yr
2 Tamoxifen [20-40mg/d] indefinitely

3304 86M2 FNCLCC Groupe Sein Protocole TAM 002 - Essai Therapeutique Nolvadex Retardé: Entry SEP-1986 to AUG-1989 (494 patients were entered)

1 Control
2 Tamoxifen [30mg/d] × 5yr (delayed 2yr or more)

3305 77L1 CMF vs. Radiotherapy Trial: N+; Postmenopausal; Entry JAN-1977 to JUL-1981 (36 patients were entered; 1990 overview synthetic data only; 3-7 additional exclusions missing; no recurrence information)

1 Radiotherapy
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

3306 77L2 CMF vs. Radiotherapy Trial: N+; Premenopausal; Entry JAN-1977 to JUL-1981 (54 patients were entered; 1990 overview synthetic data only; 0-4 additional exclusions missing; no recurrence information)

1 Oöphorectomy + Radiotherapy
2 Oöphorectomy + Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

34 Guy's and Manchester, U.K. {Bentley, Doran, Dougal, Howell, Rubens, Smith: MAR-2001 (REVISED VERSION, UPDATED NINE TIMES)}

3401 75E1 Trial C2 - Guy's L-Pam (Rubens and Howell): N+; Entry MAY-1975 to SEP-1979 (261 patients were entered)

1 Melphalan × 2yr
2 Control

3402 79E1 Guy's CMF (Rubens and Howell): N+; Premenopausal; Entry MAR-1977 to APR-1981 (44 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr
2 Control

3403 75E2 Manchester Trial I (Rubens and Howell): N+; Entry FEB-1976 to DEC-1979 (167 patients were entered)

1 Melphalan × 2yr
2 Control
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr

3404 79E3 Manchester Trial II (Rubens and Howell): N+; Entry FEB-1980 to DEC-1981 (80 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr
2 Control

3405 85L1 Guy's and Manchester (Manchester part - Howell): Postmenopausal; Entry FEB-1985 to MAR-1992 (101 patients were entered; Guy's part is 13605)

1 Tamoxifen
2 Tamoxifen + Prednisone

3406 79E2 Guy's CMF (Rubens and Howell): N+; Entry MAY-1981 to JUL-1988 (268 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr
2 Control

3407 ICI-182780 Trial: ER Effect Endpoint; Entry ? (56 patients were entered; not received)

1 ICI-182780 [6mg/d im] × 7d preoperative
2 ICI-182780 [18mg/d im] × 7d preoperative

35 Milan Istituto Nazionale per lo Studio e la Cura dei Tumori, Italy {Bonadonna, Costa, De Palo, Rilke, Saccozzi, Del Vecchio, Veronesi: JUN-2000 (THIRD REVISED VERSION)}

3501 80F B2/ Protocol 8004: N-; ER-; Entry DEC-1980 to OCT-1985 (96 patients were entered)

1 Control
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12

3502 73B B1/ Protocol 7205: N+; Entry MAY-1973 to SEP-1975 (391 patients were entered) {note: imbalance is due to proper restoration of patients whose treatment allocation cards were re-used after they had been withdrawn from active treatments}

1 Control
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12

3503 75H1 B1/ Protocol 7502: N+; Premenopausal; Entry SEP-1975 to MAY-1978 (331 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6

3504 77S B1/ Protocol 7701: N+; Postmenopausal; Entry MAY-1977 to OCT-1980 (140 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 + P + (Doxorubicin + Vincristine) [with dose intensification] × 4
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 + P + (Doxorubicin + Vincristine) [no dose intensification] × 4

3505 75H2 B1/ Protocol 7502: N+; Postmenopausal; Entry AUG-1975 to NOV-1976 (103 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6

3506 80M1 Protocol 8005A: N1-3; Entry OCT-1980 to OCT-1981 (114 patients were entered; 1985 overview synthetic data only; no recurrence information)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12 then Doxorubicin × 4

3507 80M2 Protocol 8005: N1-3; Entry OCT-1981 to 1989 (309 patients were entered; 1985 overview synthetic data only; no recurrence information)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 8 then Doxorubicin × 4

3508 80N1 Protocol 8006A: N4+; Entry OCT-1980 to MAR-1982 (102 patients were entered; 1985 overview synthetic data only; no recurrence information)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12 then Doxorubicin × 4
2 Doxorubicin × 4 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12

3509 80N2 Protocol 8006: N4+; Entry MAR-1982 to 1987 (361 patients were entered; 134 patients missing; 1985 overview synthetic data only; no recurrence information)

1 Doxorubicin × 4 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 8
2 ((Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 2 then Doxorubicin × 1) × 4

3510 73E1 Milan 1 Study: Age < 70; Entry JUN-1973 to MAY-1980 (701 patients were entered)

1 Halsted Mastectomy
2 Quadrantectomy + Radiotherapy

3511 85K Milan 2 Study: Entry JAN-1985 to DEC-1987 (705 patients were entered)

1 Quadrantectomy + Radiotherapy ('A')
2 Tumorectomy + Radiotherapy ('B')

3512 87R Milan 3 Study: Tumour < 2·5cm; N1b; Quadrantectomy + Axillary Dissection; CMF for (N+, ER+); Tamoxifen for (ER+, Postmenopausal); Entry DEC-1987 to DEC-1989 (567 patients were entered)

1 Radiotherapy [50Gy in 2Gy fractions over 35d then 10Gy boost in 5 fractions]
2 Control

3513 63D2 Milan part of International Coöperative Study: Entry JAN-1964 to JAN-1968 (716 patients were entered; some ineligibles missing)

1 Extended Radical Mastectomy
2 Halsted Mastectomy

3514 73E2 Milan 1 Study: Age < 70; Axillary Clearance; N+; Second Randomisation from Radical (Halsted) Mastectomy Arm; Entry JUL-1973 to JAN-1976 (22 patients were entered)

1 Control
2 Radiotherapy [to nodes]

3515 73E3 Milan 1 Study: Age < 70; Axillary Clearance; N+; Second Randomisation from Quadrantectomy Arm; Entry JUL-1973 to FEB-1976 (34 patients were entered)

1 Radiotherapy [to breast]
2 Radiotherapy [to breast] + Radiotherapy [to nodes]

3516 Retinoid Trial, 4-Way: Patients already treated for breast cancer; Plasma Retinol Endpoint; Entry JAN-1986 to JUN-1986 (101 patients were entered; not received)

1 Control
2 N-4-Hydroxyphenyl Fenretinide [100mg/d] × 1yr
3 N-4-Hydroxyphenyl Fenretinide [200mg/d] × 1yr
4 N-4-Hydroxyphenyl Fenretinide [300mg/d] × 1yr

3517 86B Retinoid Trial, 2-Way: Patients already treated for breast cancer; Age 33-68; T1-2 N0; Entry OCT-1986 to JUL-1993 (2972 patients were entered)

1 Fenretinide [200mg/d] × 5yr
2 Control

3518 Italian Tamoxifen Prevention Trial: Age 35-70; Hysterectomised; Entry 1992 ff. (not received; superseded by 28701)

1 Tamoxifen [20mg/d] × 5yr
2 Control

3519 90R Milan Trial IV: Entry DEC-1990 to JAN-1994 (111 patients were entered)

1 Radiotherapy [boost]
2 Radiotherapy [implant] + Radiotherapy [external]

3520 93J High-Dose Therapy Trial: N4+; Entry 1993 ff. (not received)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + 4-Epi-Doxorubicin
2 Sequential Therapy [high-dose]

3521 European Coöperative Trial in Operable Breast Cancer: Tumour > 2cm; Age 18-70; Entry post-1995 (not received)

1 4-Epi-Doxorubicin [75mg/m²] q3wk × 4 then (Cyclophosphamide [600mg/m²] + Methotrexate [40mg/m²] + 5-Fluoro-Uracil [600mg/m² d1,8]) q4wk × 4 then Tamoxifen [20mg/d] × 5yr
2 (4-Epi-Doxorubicin [60mg/m²] then Paclitaxel [200mg/m² m15 over 3h]) × 4 then (Cyclophosphamide [600mg/m²] + Methotrexate [40mg/m²] + 5-Fluoro-Uracil [600mg/m² d1,8]) q4wk × 4 then Tamoxifen [20mg/d] × 5yr
3 (4-Epi-Doxorubicin [60mg/m²] then Paclitaxel [200mg/m² m15 over 3h]) × 4 preoperative then (Cyclophosphamide [600mg/m²] + Methotrexate [40mg/m²] + 5-Fluoro-Uracil [600mg/m² d1,8]) q4wk × 4 preoperative then Tamoxifen [20mg/d] × 5yr

36 Case Western Reserve University, Cleveland, U.S.A. {(Crowe), Gordon: MAR-1995 (THIRD REVISED VERSION)}

3601 74G2 Alpha: Stage II; Entry JAN-1976 to MAY-1979 (304 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12 + Tamoxifen [20mg bd] × 1yr
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12 + Tamoxifen [20mg bd] × 1yr + Bacillus Calmette-Guèrin

3602 79C1 Beta: Premenopausal; ER+; Stage II-III; Entry SEP-1979 to DEC-1985 (43 patients were entered)

1 Oöphorectomy + Tamoxifen × 3yr
2 Oöphorectomy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + V + P) × 1yr + Tamoxifen × 3yr

3603 79C2 Beta: Postmenopausal; ER+; Stage II-III; Entry AUG-1979 to SEP-1985 (94 patients were entered)

1 Tamoxifen × 3yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + V + P) × 1yr + Tamoxifen × 3yr

3604 74G1 Alpha: Stage II; Entry SEP-1974 to JAN-1976 (19 patients were entered)

1 Control
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12 + Tamoxifen [20mg bd] × 1yr
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12 + Tamoxifen [20mg bd] × 1yr + Bacillus Calmette-Guèrin

37 London Royal Marsden Hospital / Institute of Cancer Research, U.K. {Bliss, Davidson, Easton, Powles: APR-2001 (SECOND REVISED VERSION, UPDATED)}

3701 79K Adjuvant Aminoglutethimide No. 37: Postmenopausal; N+; Entry JAN-1979 to MAY-1986 (355 patients were entered)

1 (Aminoglutethimide [250mg qd] + Hydrocortisone) × 2yr
2 Control

3702 Chemoprevention Study: High Risk; Entry 1986 ff. (2470 patients were entered by OCT-1995; not received)

1 Tamoxifen [20mg/d] × 3yr
2 Control

3703 90T Neoadjuvant Feasibility Study: Stage I; T1-2/(operable T3); Entry FEB-1990 to AUG-1995 (309 patients were entered; 4 missing)

1 (Mitozantrone + Methotrexate + Mitomycin-C) × 8 + Tamoxifen × 5yr
2 (Mitozantrone + Methotrexate + Mitomycin-C) × 4 + Tamoxifen preoperative then (Mitozantrone + Methotrexate + Mitomycin-C) × 4 postoperative + Tamoxifen × 5yr

3704 Chemotherapy Trial: N+; Entry ? (47 patients were entered; not received)

1 Chlorambucil
2 Doxorubicin + Vincristine + 5-Fluoro-Uracil + Methotrexate + Chlorambucil

3705 75U Benoral Trial: Stage II; Entry JAN-1975 to SEP-1978 (160 patients were entered)

1 Benorylate [8g/d] × 18m
2 Control

3706 93U Large Operable Breast Cancer Trial: Entry OCT-1993 to FEB-1999 (426 patients were entered)

1 4-Epi-Doxorubicin + Cis-Platinum + 5-Fluoro-Uracil
2 Doxorubicin + Cyclophosphamide

3707 90N Bisphosphonate Trial: Entry 1990 to 1996 (311 patients were entered; not received)

1 Bisphosphonate Clodronate × 2yr
2 Control

3708 95H TRAFIC Trial: Entry 1995 ff. (not received)

1 Continuous Infusional Chemotherapy
2 Conventional Chemotherapy

3709 86R1 START Trial A Pilot: T1-3 N0-1 M0; Age 18+; Complete Excision (Breast Conservation or Mastectomy); Entry FEB-1986 ff. (1410 patients were entered; supersedes 16902; not received)

1 Radiotherapy [50Gy in 25 fractions over 5wk]
3 Radiotherapy [42·9Gy in 13 fractions over 5wk]
2 Radiotherapy [39Gy in 13 fractions over 5wk]

3710 86R2 START Trial A: T1-3 N0-1 M0; Age 18+; Complete Excision (Breast Conservation or Mastectomy); Entry ? (target 2000 patients; not received)

1 Radiotherapy [50Gy in 25 fractions over 5wk]
3 Radiotherapy [41·6Gy in 13 fractions over 5wk]
2 Radiotherapy [39Gy in 13 fractions over 5wk]

3711 86R3 START Trial B: T1-3 N0-1 M0; Age 18+; Complete Excision (Breast Conservation or Mastectomy); Entry 1994 ff. (supersedes 16904; not received)

1 Radiotherapy [50Gy in 25 fractions over 5wk]
2 Radiotherapy [40Gy in 15 fractions over 3wk]

38 Scandinavian Adjuvant Chemotherapy Study Group, Norway {Nissen-Meyer: APR-1995 (UPDATED FIVE TIMES)}

3801 77A1 Study 2A (4-Way): N+; Entry MAR-1977 to JUN-1985 (360 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine) perioperative
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine) perioperative + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine) perioperative + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr + Corynebacterium Parvum
4 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine) perioperative + Corynebacterium Parvum

3802 65A1 Study 1A (excluding Centres 9 and 10): Entry JAN-1965 to JUL-1985 (1011 patients were entered)

1 Radiotherapy
2 Radiotherapy + Cyclophosphamide perioperative × 6d

3803 65A2 Study 1B (Centre 9, where treatment was delayed 2-4 weeks for Radiotherapy): Entry FEB-1966 to MAY-1971 (116 patients were entered)

1 Radiotherapy after 3wk
2 (Radiotherapy + Cyclophosphamide × 6d) after 3wk

3804 57A1 N.R.H. (Nissen-Meyer): Premenopausal; Low Risk; N-; Entry NOV-1957 to DEC-1963 (169 patients were entered)

1 Control
2 Ovarian Irradiation

3805 57A2 N.R.H. (Nissen-Meyer): Postmenopausal; Ovarian Irradiation; Entry DEC-1957 to JUN-1961 (177 patients were entered)

1 Control
2 Ovarian Irradiation

3806 77A3 Study 2B: N-; Entry MAR-1977 to NOV-1985 (750 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine) perioperative
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine) perioperative + Corynebacterium Parvum

3807 65A3 Study 1A (Centre 10): Entry MAR-1966 to FEB-1971 (79 patients were entered; nonstandard randomisation)

1 Radiotherapy
2 Radiotherapy + Cyclophosphamide perioperative × 6d

3808 77A2 Study 2A (Centre 11, 2-Way): N+; Entry APR-1981 to JUN-1982 (22 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine) perioperative
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine) perioperative + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr

3809 57B N.R.H. Trial 3 (Nissen-Meyer): High Risk, Premenopausal; Entry DEC-1957 to NOV-1963 (121 patients were entered)

1 Oöphorectomy
2 Ovarian Irradiation

39 German Breast Cancer Study Group {Ahlert, Bastert, Rauschecker, Sauerbrei, Scheurlen, Schmoor, Schumacher: JUN-2001 (THIRD REVISED VERSION, UPDATED)}

3901 84A1 GBSG Protocol 02 (Bastert and Scheurlen): Heidelberg Part of Randomised Trial of Chemo/Hormonal Therapy in Early Breast Cancer; N+; Entry JUN-1984 to NOV-1986 (251 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 + Tamoxifen [10mg tid] × 2yr
4 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 + Tamoxifen [10mg tid] × 2yr

3902 84A2 GBSG Protocol 03 (Bastert, Sauerbrei, Scheurlen, Schmoor and Schumacher): Postoperative Local Radiotherapy as a Supplement to Systemic Chemotherapy in Potentially Curable Breast Cancer; Axillary Clearance; N+; Entry JUL-1984 to DEC-1989 (199 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 2 + Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4

3903 Randomised Trial on Active Specific Immunotherapy (ASI) (Ahlert, Bastert, Scheurlen, Schumacher et al.): Entry 1991 ff. (planned but never started; not received)

1 Unknown
2 Unknown

3904 84A3 GBSG Protocol 01 (Rauschecker, Sauerbrei, Schmoor and Schumacher): Multi-Centre Trial of Mastectomy Versus Lumpectomy (Randomised Subset); T1 N0 M0; Entry NOV-1983 to OCT-1988 (72 patients were entered)

1 Mastectomy
2 Lumpectomy + Radiotherapy

3905 84A4 GBSG Protocol 02 (Bastert, Sauerbrei, Schmoor and Schumacher): Freiburg Part of Randomised Trial of Chemo/Hormonal Therapy in Early Breast Cancer; N+; Premenopausal; Entry DEC-1986 to OCT-1989 (100 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6

3906 84A5 GBSG Protocol 02 (Bastert, Sauerbrei, Schmoor and Schumacher): Freiburg Part of Randomised Trial of Chemo/Hormonal Therapy in Early Breast Cancer; N+; Perimenopausal/Postmenopausal; Entry DEC-1986 to NOV-1989 (130 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 + Tamoxifen [10mg tid] × 2yr
4 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 + Tamoxifen [10mg tid] × 2yr

3908 91J GBSG V (Rauschecker): Age 45-75; Tumour 2cm; T1 N0; Grade 1-2; No EIC; N0; ER+; Entry MAR-1991 ff. (361 patients were entered; not received)

1 Control
2 Radiotherapy
3 Tamoxifen × 2yr
4 Radiotherapy + Tamoxifen × 2yr

40 N.S.A.B.C., Israel {Biran, Borovik, Brufman, Fried, Hayat, Robinson, Wigler: JUN-2000 (SECOND REVISED VERSION)}

4001 77D1 Trial I (Brufman) - Medial Tumours: Entry JUN-1977 to SEP-1980 (76 patients were entered; some additional patients missing)

1 Radiotherapy then Melphalan + 5-Fluoro-Uracil
2 Radiotherapy + Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

4002 77D2 Trial I (Brufman) - Lateral Lesions: Entry MAY-1977 to SEP-1980 (94 patients were entered; some additional patients missing)

1 Radiotherapy
2 Melphalan + 5-Fluoro-Uracil
3 (Melphalan + 5-Fluoro-Uracil) × 1 then Radiotherapy + Melphalan + 5-Fluoro-Uracil

4003 87C Mastectomy or Lumpectomy (Wigler): N+; Entry MAY-1987 to APR-1992 (158 patients were entered)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 Cyclophosphamide + Mitozantrone + 5-Fluoro-Uracil

4004 80W National Breast Cancer Group BR81 (Hayat): Premenopausal/Postmenopausal; Stage II; T1-2 N1 M0; Age < 71; Entry DEC-1980 to APR-1983 (112 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 then Radiotherapy [45Gy Co, local tangential field megavoltage] then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6

4005 83A Br-02-83 (Borovik, Robinson): N+; Entry JUL-1983 to MAR-1985 (203 patients were entered; 98 missing - thought to be same as 6001)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 ((Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) / (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Doxorubicin + Vinblastine)) alternating

41 Oxford Churchill Hospital, U.K. {Collins, Crossley, Durrant, Harris: DEC-2000 (UPDATED FOUR TIMES)}

4101 77E Study of Prophylactic Chemotherapy in Potentially Curable Breast Carcinoma: Entry MAY-1977 to MAR-1983 (306 patients were entered)

1 Control
2 Melphalan × 2yr
3 (Melphalan + Methotrexate + 5-Fluoro-Uracil) × 2yr

4102 Chemotherapy Trial: Epidermal Growth Factor Positive Tumours; ?N+; Entry ? (50 patients were entered by 1991; not received)

1 Chemotherapy
2 Control

42 Birmingham General Hospital, U.K. {Faux, Oates, Powell: JUN-2000 (UPDATED SIX TIMES)}

4201 67A Cyclophosphamide versus 5-Fluoro-Uracil versus Nil: Entry OCT-1967 to JAN-1976 (251 patients were entered)

1 Control
2 Cyclophosphamide × 1yr
3 5-Fluoro-Uracil × 1yr

43 Naples University Federico II, Italy {Bianco, Carlomagno, De Laurentiis, De Placido: JUN-2000 (THIRD REVISED VERSION)}

4301 78C1 G.U.N.-1 Study: Postmenopausal/(N-, Premenopausal); Entry JAN-1978 to DEC-1979 (60 patients were entered) {note: patients aged over 70 inadvertently randomised into the G.U.N. study have been retained}

1 Tamoxifen [30mg/d] × 2yr
2 Control

4302 78C2 G.U.N.-1 Study: Postmenopausal/(N-, Premenopausal); 2:1 Randomisation; Entry JAN-1980 to DEC-1980 (46 patients were entered) {note: patients aged over 70 inadvertently randomised into the G.U.N. study have been retained}

1 Tamoxifen [30mg/d] × 2yr
2 Control

4303 78C3 G.U.N.-1 Study: Postmenopausal/(N-, Premenopausal); 1:1 Randomisation; Entry JAN-1981 to DEC-1982 (136 patients were entered) {note: patients aged over 70 inadvertently randomised into the G.U.N. study have been retained}

1 Tamoxifen [30mg/d] × 2yr
2 Control

4304 78C4 G.U.N.-1 Study: Postmenopausal/(N-, Premenopausal); 1:2 Randomisation; Entry JAN-1983 to DEC-1983 (66 patients were entered) {note: patients aged over 70 inadvertently randomised into the G.U.N. study have been retained}

1 Tamoxifen [30mg/d] × 2yr
2 Control

4305 78C5 G.U.N.-2 Study: N+; Premenopausal; Entry FEB-1978 to DEC-1983 (125 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 9 + Tamoxifen [10mg tid] × 2yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 9

4306 G.U.N. Study - Randomisation after 2yr Tamoxifen: N+; Postmenopausal; ER+/ER?; Entry 1985 ff. (never activated)

1 Tamoxifen [30mg/d] × 2yr
2 Tamoxifen [30mg/d] until relapse

4307 84K1 G.U.N.-3 Study: N+; (Premenopausal, ER-/ER?)/(Postmenopausal, ER-)/(Stage III, Premenopausal/Postmenopausal); Entry NOV-1984 to DEC-1991 (220 patients were entered)

1 ((Cyclophosphamide [100mg/m² os d1-14] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) / (4-Epi-Doxorubicin [75mg/m² iv d1,8] + Vincristine [1·4mg/m² iv d1,8])) q21d × 6 alternating
2 (Cyclophosphamide [100mg/m² os d1-14] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q21d × 6

4308 84K2 G.U.N. Study: N+; Premenopausal; ER+; Entry 1985 ff. (closed early; not received)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 Oöphorectomy + Tamoxifen [30mg/d] × 2yr

4309 91Q G.O.C.S.I. MAM1: Entry SEP-1991 to MAR-1997 (466 patients were entered)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 Doxorubicin then Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) then Goserelin + Tamoxifen
4 Doxorubicin then Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil then Goserelin + Tamoxifen

4310 96N G.O.C.S.I. MAM2: Entry 1996 to 2000 (1000 patients were entered; not received)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 4-Epi-Doxorubicin then Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

4311 98B Taxit216: Entry 1998 ff. (400 patients were entered by JUL-2000; not received)

1 4-Epi-Doxorubicin then Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 4-Epi-Doxorubicin then Docetaxel then Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
3 4-Epi-Doxorubicin × 14 then Docetaxel × 14 then Cyclophosphamide [3g/m²]

44 South Sweden Breast Cancer Group {Aspegren, Holmberg, Malmström, Möller, Rydén: APR-2001 (THIRD REVISED VERSION, UPDATED)}

4401 78A1 SB II:1: Premenopausal; Axillary Clearance; Entry JAN-1978 to DEC-1983 (429 patients were entered)

1 Radiotherapy [megavoltage]
2 Radiotherapy [megavoltage] + Cyclophosphamide × 1yr
3 Cyclophosphamide × 1yr

4402 78A2 SB II:1: Postmenopausal; Axillary Clearance; Entry JAN-1978 to FEB-1985 (718 patients were entered; PR imbalance is due to chance)

1 Radiotherapy [megavoltage]
2 Radiotherapy [megavoltage] + Tamoxifen [30mg/d] × 1yr
3 Tamoxifen [30mg/d] × 1yr

4403 85G SB II:2: Premenopausal; Entry JUN-1985 to JAN-1991 (428 patients were entered)

1 Control
2 Tamoxifen [20mg/d] × 2yr

4404 79T5 SB II:2 (SSBCG part of SESBCG-Örebro-Karlstad Study): Postmenopausal; Entry JUN-1987 to DEC-1994 (1220 patients were entered)

1 Tamoxifen [20mg/d] × 2yr
2 Tamoxifen [20mg/d] × 5yr

4405 91P Swedish Multi-Centre Study (Holmberg, Malmström, Möller, Wallgren): Sector Resection; Unifocal Tumour; Entry 1991 to 1998 (1200 patients were entered; not received)

1 Radiotherapy
2 Control

4406 Swedish Multi-Centre DCIS Study: Conservative Surgery (Quadrantectomy); Entry 1988 ff. (not received)

1 Control
2 Radiotherapy

45 Toronto Princess Margaret Hospital, Canada {Hayward, Meakin, Panzarella: MAY-1990 (REVISED VERSION, UPDATED)}

4501 65B1 Series I: Age < 45; Entry JUN-1965 to NOV-1972 (130 patients were entered)

1 Control
2 Ovarian Irradiation

4502 65B2 Series II (Age 45-59) and III (Age 60+): Age 45+; Entry JUN-1965 to NOV-1972 (649 patients were entered - 494 Series II, 155 Series III)

1 Control
2 Ovarian Irradiation
3 Ovarian Irradiation + Prednisone

4503 73F Surgery and Radiotherapy: Age < 75; Entry JUL-1973 ff. (25 patients were entered; terminated early; not received)

1 Modified Radical Mastectomy + Axillary Dissection
2 Partial Mastectomy + Radiotherapy

46 Danish Cancer Registry {Carstensen, Palshof: JUN-2000 (REVISED VERSION, UPDATED THRICE)}

4601 72J1 HMC-76 (Adjuvant Tamoxifen versus Placebo): Premenopausal/Perimenopausal; Entry APR-1975 to FEB-1978 (216 patients were entered)

1 Tamoxifen [10mg tid] × 2yr
2 Control

4602 72J2 HMC-77 (Adjuvant Tamoxifen and Diethylstilboestrol versus Placebo): Postmenopausal; Entry APR-1975 to FEB-1978 (156 patients were entered)

1 Tamoxifen [10mg tid] × 2yr
2 Control
3 Diethylstilboestrol [3mg/d] × 2yr

47 National Surgical Adjuvant Project for Breast and Bowel Cancers, U.S.A. {Anderson, Brown, Bryant, Fisher, Ghosal, Herberman, Redmond, Rockette, Wieand: JUL-2000 (FOURTH REVISED VERSION)}

4701 72B Protocol B-05 (randomised subset): N+; Entry JUL-1972 to JAN-1975 (380 patients were entered)

1 Control
2 Melphalan × 2yr

4702 75M Protocol B-07: N+; Entry NOV-1974 to MAY-1976 (741 patients were entered)

1 Melphalan × 2yr
2 (Melphalan + 5-Fluoro-Uracil) × 2yr

4703 76J Protocol B-08: N+; Entry MAR-1976 to APR-1977 (737 patients were entered; 16 'ineligible' patients missing)

1 (Melphalan + 5-Fluoro-Uracil) × 2yr
2 (Melphalan + 5-Fluoro-Uracil + Methotrexate) × 2yr

4704 77K Protocol B-09: N+; Entry JAN-1977 to MAY-1980 (1891 patients were entered)

1 (Melphalan + 5-Fluoro-Uracil) × 2yr
2 (Melphalan + 5-Fluoro-Uracil) × 2yr + Tamoxifen [10mg bd] × 2yr

4706 58A1 Protocol B-01 (Part I): Entry APR-1958 to OCT-1958 (103 patients were entered; no recurrence site information)

1 Control
2 Triethylenephosphoramide perioperative

4707 77Q Protocol B-10: N+; Entry MAY-1977 to MAR-1981 (265 patients were entered)

1 Melphalan + 5-Fluoro-Uracil
2 Melphalan + 5-Fluoro-Uracil + Corynebacterium Parvum + Hydrocortisone

4708 81C1 Protocol B-11: N+; ER-; Entry JUN-1981 to JAN-1982 (154 patients were entered; up to 5 additional 'ineligible' patients might be missing)

1 Melphalan + 5-Fluoro-Uracil
2 Melphalan + 5-Fluoro-Uracil + Doxorubicin

4709 81D1 Protocol B-12: N+; ER+; Entry JUN-1981 to JAN-1982 (216 patients were entered; up to 10 additional 'ineligible' patients might be missing)

1 Melphalan + 5-Fluoro-Uracil + Tamoxifen [20mg/d] × 2yr
2 Melphalan + 5-Fluoro-Uracil + Doxorubicin + Tamoxifen [20mg/d] × 2yr

4710 81E Protocol B-13: N-; ER-; Entry AUG-1981 to JAN-1988 (760 patients were entered)

1 Control
2 ((Methotrexate then 5-Fluoro-Uracil) + Folinic Acid) × 11m

4711 82%1 Protocol B-14 (randomised subset): N-; ER+; Entry JAN-1982 to JAN-1988 (2892 patients were entered)

1 Control
2 Tamoxifen [20mg/d] × 5/10yr

4712 84B Protocol B-15: N+; Age < 60; Entry OCT-1984 to OCT-1988 (2338 patients were entered)

1 Doxorubicin + Cyclophosphamide
2 Doxorubicin + Cyclophosphamide + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) re-induction therapy
3 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

4713 84C1 Protocol B-16 (first series): N+; Age 51+; Postmenopausal; Entry OCT-1984 to JUN-1985 (224 patients were entered)

1 (Melphalan + 5-Fluoro-Uracil) × 2yr + Tamoxifen [20mg/d] × 4yr or indefinitely
2 (Doxorubicin + Cyclophosphamide) × 3m + Tamoxifen [20mg/d] × 4yr or indefinitely
3 Tamoxifen [20mg/d] × 4yr or indefinitely

4714 84C2 Protocol B-16 (second series): N+; Age 51+; Postmenopausal; Entry JUN-1985 to APR-1989 (1072 patients were entered)

1 (Melphalan + Doxorubicin + 5-Fluoro-Uracil) × 2yr + Tamoxifen [20mg/d] × 5yr or indefinitely
2 (Doxorubicin + Cyclophosphamide) × 3m + Tamoxifen [20mg/d] × 5yr or indefinitely
3 Tamoxifen [20mg/d] × 5yr or indefinitely

4715 76B Protocol B-06: N-/N+; Axillary Clearance; Entry APR-1976 to JAN-1984 (2163 patients were entered including 58 'ineligibles')

1 Total Mastectomy + Nil/(Melphalan + 5-Fluoro-Uracil)
2 Segmental Mastectomy + Nil/(Melphalan + 5-Fluoro-Uracil)
3 Segmental Mastectomy + Radiotherapy [50Gy in 5wk] + Nil/(Melphalan + 5-Fluoro-Uracil)

4716 71C1 Protocol B-04: N- subset; Entry JUL-1971 to SEP-1974 (1159 patients were entered)

1 Radical Mastectomy
2 Simple Mastectomy + Radiotherapy [megavoltage]
3 Simple Mastectomy

4717 61H1 Protocol B-03, Option C (Part I): Premenopausal; Age 30-49; 1:2:1 Randomisation; Entry OCT-1961 to APR-1967 (246 patients were entered; no recurrence site information)

1 Control
2 Oöphorectomy
3 Triethylenephosphoramide perioperative

4718 61B1 Protocol B-02, Option A: Premenopausal; Entry OCT-1961 to APR-1967 (320 patients were entered; no recurrence site information)

1 Triethylenephosphoramide perioperative
2 5-Fluoro-Uracil perioperative

4719 71C2 Protocol B-04: N+ subset; Entry JUL-1971 to SEP-1974 (606 patients were entered)

1 Radical Mastectomy
2 Simple Mastectomy + Radiotherapy

4720 Protocol B-17 (randomised subset): Lumpectomy; Ductal Carcinoma in Situ (DCIS); N-; Entry OCT-1985 to DEC-1990 (818 patients were entered)

1 Radiotherapy [50Gy to breast]
2 Control

4721 88A1 Protocol B-18: Age < 50; Entry OCT-1988 to APR-1993 (781 patients were entered)

1 (Doxorubicin + Cyclophosphamide) postoperative
2 (Doxorubicin + Cyclophosphamide) preoperative

4722 88A2 Protocol B-18: Age 50+; Entry OCT-1988 to APR-1993 (742 patients were entered)

1 (Doxorubicin + Cyclophosphamide) postoperative + Tamoxifen [20mg/d] × 5yr
2 (Doxorubicin + Cyclophosphamide) preoperative + Tamoxifen [20mg/d] × 5yr

4723 88B Protocol B-19: N-; ER-; Entry OCT-1988 to JUL-1990 (1095 patients were entered)

1 Methotrexate + 5-Fluoro-Uracil + Folinic Acid rescue
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

4724 88C Protocol B-20: N-; ER+; Entry OCT-1988 to MAR-1993 (2363 patients were entered)

1 Tamoxifen [20mg/d] × 5yr
2 Methotrexate + 5-Fluoro-Uracil + Folinic Acid rescue + Tamoxifen [20mg/d] × 5yr
3 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Tamoxifen [20mg/d] × 5yr

4725 89L1 Protocol B-21: Part 1: No Small (< 1 cm) Invasive Tumours; N-; ER Unknown; Lumpectomy with Axillary Clearance; Entry JUN-1989 to DEC-1998 (1009 patients were entered; closed early)

1 Radiotherapy
2 Radiotherapy + Tamoxifen [20mg/d] × 5yr
3 Tamoxifen [20mg/d] × 5yr

4726 89M Protocol B-22: N+; Entry JUL-1989 to MAY-1991 (2305 patients were entered)

1 (Doxorubicin + Cyclophosphamide) [standard dose]
2 (Doxorubicin + Cyclophosphamide) [intensification, standard dose]
3 (Doxorubicin + Cyclophosphamide) [intensification, high dose]

4727 81C2 Protocol B-11: N+; (Age < 50, ER-/PR-)/(Age 50-59, PR-); Entry FEB-1982 to SEP-1984 (553 patients were entered; up to 5 additional 'ineligible' patients might be missing)

1 Melphalan + 5-Fluoro-Uracil
2 Melphalan + 5-Fluoro-Uracil + Doxorubicin

4728 81D2 Protocol B-12: N+; (Age < 50, ER+, PR+)/(Age 50-59, PR+)/(Age 60+); Entry FEB-1982 to SEP-1984 (890 patients were entered; 1 additional 'ineligible' patient might be missing)

1 Melphalan + 5-Fluoro-Uracil + Tamoxifen [20mg/d] × 2yr
2 Melphalan + 5-Fluoro-Uracil + Doxorubicin + Tamoxifen [20mg/d] × 2yr

4729 82%2 Protocol B-14 (second randomisation): N-; ER+; Entry JUN-1987 to MAY-1994 (1172 patients were entered)

1 Tamoxifen [20mg/d] × 5yr
2 Tamoxifen [20mg/d] × 10yr

4730 Tamoxifen Chemoprevention in High-Risk Women: Entry 1992 ff. (11000 patients were entered when study suspended; resumed; not received)

1 Tamoxifen [20mg/d] × 5yr
2 Control

4731 58A2 Protocol B-01 (Part II): Entry OCT-1958 to MAR-1961 (603 patients were entered; no recurrence site information)

1 Control
2 Triethylenephosphoramide perioperative

4732 58A3 Protocol B-01 (Part III): Entry APR-1961 to OCT-1961 (119 patients were entered; no recurrence site information)

1 Control
2 Triethylenephosphoramide perioperative

4733 61B2 Protocol B-02, Option D: Postmenopausal; Entry OCT-1961 to MAY-1967 (728 patients were entered; no recurrence site information)

1 Triethylenephosphoramide perioperative
2 5-Fluoro-Uracil perioperative

4734 61H2 Protocol B-03, Option F (N- Sub-Set): Postmenopausal; Entry OCT-1961 to MAY-1967 (186 patients were entered; no recurrence site information)

1 Triethylenephosphoramide perioperative
2 5-Fluoro-Uracil perioperative

4735 61H3 Protocol B-03, Option C (Part II): Premenopausal; 1:2 Randomisation; Entry MAY-1967 to SEP-1970 (74 patients were entered; no recurrence site information)

1 Triethylenephosphoramide perioperative
2 Oöphorectomy

4736 61H4 Protocol B-03, Option B (Part I): Premenopausal; 1:2:1 Randomisation; Entry OCT-1961 to MAY-1967 (118 patients were entered; no recurrence site information)

1 Control
2 Radiotherapy
3 Triethylenephosphoramide perioperative

4737 61H5 Protocol B-03, Option E (Part I): Postmenopausal; 1:2:1 Randomisation; Entry OCT-1961 to MAY-1967 (562 patients were entered; no recurrence site information)

1 Control
2 Radiotherapy
3 Triethylenephosphoramide perioperative

4738 61H6 Protocol B-03, Option F (N+ Sub-Set, Part I): Postmenopausal; 1:2:1 Randomisation; Entry OCT-1961 to APR-1967 (164 patients were entered; no recurrence site information)

1 Control
2 Radiotherapy
3 Triethylenephosphoramide perioperative

4739 61H7 Protocol B-03, Option B (Part II): Premenopausal; 1:2 Randomisation; Entry MAY-1967 to JUL-1968 (17 patients were entered; no recurrence site information)

1 Triethylenephosphoramide perioperative
2 Radiotherapy

4740 61H8 Protocol B-03, Option E (Part II): Postmenopausal; 1:2 Randomisation; Entry MAY-1967 to AUG-1968 (107 patients were entered; no recurrence site information)

1 Control
2 Radiotherapy

4741 61H9 Protocol B-03, Option F (N+ Sub-Set, Part II): 1:2 Randomisation; Entry MAY-1967 to AUG-1968 (23 patients were entered; no recurrence site information)

1 Control
2 Radiotherapy

4742 Protocol B-24: DCIS; Lumpectomy; Entry MAY-1991 to APR-1994 (1804 patients were entered)

1 Radiotherapy
2 Radiotherapy + Tamoxifen [20mg/d]

4743 91H Protocol B-23 (Herberman): N-; ER-; Entry MAY-1991 to DEC-1998 (2008 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 + Tamoxifen [10mg bd] × 5yr
3 (Doxorubicin + Cyclophosphamide) × 4
4 (Doxorubicin + Cyclophosphamide) × 4 + Tamoxifen [10mg bd] × 5yr

4744 92F Protocol B-25: N+; Entry APR-1992 to FEB-1994 (2548 patients were entered)

1 Doxorubicin + Cyclophosphamide + G-Colony Stimulating Factor [C-1200] × 4
2 Doxorubicin + Cyclophosphamide + G-Colony Stimulating Factor [C-2400] × 2
3 Doxorubicin + Cyclophosphamide + G-Colony Stimulating Factor [C-2400] × 4

4745 Protocol B-26: Entry ? (109 patients were entered by APR-1995; not received)

1 Paclitaxel infusion × 3h + G-Colony Stimulating Factor
2 Paclitaxel infusion × 12h

4746 89L2 Protocol B-21, Part 2 (Intergroup): No Small (1 cm or less) Invasive Tumours; N-; Lumpectomy with Axillary Clearance; Entry MAR-1996 ff. (target 1690 patients; not received)

1 Radiotherapy
2 Radiotherapy + Tamoxifen [20mg/d] × 5yr
3 Tamoxifen [20mg/d] × 5yr

4747 95J Protocol B-27: Entry 1995 ff. (765 patients were entered by OCT-1997; not received)

1 (Doxorubicin + Cyclophosphamide) × 4 preoperative then Surgery then Tamoxifen × 5yr
2 (Doxorubicin + Cyclophosphamide) × 4 preoperative then Docetaxel × 4 preoperative then Surgery then Tamoxifen × 5yr
3 (Doxorubicin + Cyclophosphamide) × 4 preoperative then Surgery then Docetaxel × 4 then Tamoxifen × 5yr

4748 95K1 Protocol B-28: N+; Age < 50; ER+; Entry 1995 ff. (457 patients were entered to 4748-4750 by MAR-1996; not received)

1 (Doxorubicin + Cyclophosphamide) × 4 then Tamoxifen × 5yr
2 (Doxorubicin + Cyclophosphamide) × 4 then Paclitaxel × 4 then Tamoxifen × 5yr

4749 95K2 Protocol B-28: N+; Age < 50; ER-/ER?; Entry 1995 ff. (457 patients were entered to 4748-4750 by MAR-1996; not received)

1 (Doxorubicin + Cyclophosphamide) × 4
2 (Doxorubicin + Cyclophosphamide) × 4 then Paclitaxel × 4

4750 95K3 Protocol B-28: N+; Age 50+; Entry 1995 ff. (457 patients were entered to 4748-4750 by MAR-1996; not received)

1 (Doxorubicin + Cyclophosphamide) × 4 then Tamoxifen × 5yr
2 (Doxorubicin + Cyclophosphamide) × 4 then Paclitaxel × 4 then Tamoxifen × 5yr

4751 96F Protocol B-29: N-; ER+; Entry 1996 ff. (not received)

1 Tamoxifen × 5yr
2 Octreotide + Tamoxifen × 5yr
3 Doxorubicin + Cyclophosphamide + Tamoxifen × 5yr
4 Doxorubicin + Cyclophosphamide + Octreotide + Tamoxifen × 5yr

49 Southeastern Cancer Study Group, U.S.A. {Carpenter, Raney, Stagg: OCT-1995 (REVISED VERSION)}

4901 76A1 Southeastern Cancer Study Group Adjuvant Breast Trial 1: N1-3; Entry JUN-1976 to JUL-1982 (311 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12m

4902 76A2 Southeastern Cancer Study Group Adjuvant Breast Trial 1: Axillary Clearance; N4+; Entry NOV-1976 to JUL-1981 (169 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12m
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m + Radiotherapy

4903 76A3 Southeastern Cancer Study Group Adjuvant Breast Trial 1: Axillary Clearance; N4+; Entry FEB-1980 to DEC-1983 (147 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m + Radiotherapy

4904 76A4 Southeastern Cancer Study Group Adjuvant Breast Trial 2: N+; Entry AUG-1983 to NOV-1990 (528 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) [escalating dose] × 6m
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) [escalating dose] × 6m

50 Scottish Cancer Trials Office {Chetty, Dean, Forrest, Stewart, Stroner: JUN-2000 (REVISED VERSION)}

5001 74C Trial II: Age < 71; Radical Radiotherapy; Entry APR-1974 to MAY-1978 (297 patients were entered)

1 Radiotherapy
2 Radiotherapy + 5-Fluoro-Uracil × 1yr

5002 78D1 Pilot B: Postmenopausal; N+; Entry APR-1978 to MAR-1980 (107 patients were entered)

1 Tamoxifen [10mg bd] × 5yr or more
2 Control

5003 78D2 Scottish B: Postmenopausal; N+; Entry MAR-1980 to SEP-1984 (365 patients were entered)

1 Tamoxifen [10mg bd] × 5yr or indefinitely until recurrence
2 Control

5004 78D3 Scottish C: N-; Entry MAR-1980 to SEP-1984 (758 patients were entered)

1 Tamoxifen [10mg bd] × 5yr or indefinitely until recurrence
2 Control

5005 78D4 Scottish D: No node biopsy; Stage I-II; Age < 70; Entry APR-1980 to MAY-1984 (93 patients were entered)

1 Radiotherapy [orthovoltage/megavoltage] + Tamoxifen [10mg bd] × 5yr or indefinitely until recurrence
2 Radiotherapy [orthovoltage/megavoltage]
3 Tamoxifen [10mg bd] × 5yr or indefinitely until recurrence
4 Control

5006 64D1 South-East Scotland Radiotherapy Trial: 'Eligible' Patients; Entry APR-1964 to MAR-1971 (561 patients were entered)

1 Radiotherapy + Simple Mastectomy
2 Radical Mastectomy

5007 74B Edinburgh Radiotherapy Trial I: Age < 71; Simple Mastectomy; N- (sample/clinical); Entry APR-1974 to JAN-1980 (348 patients were entered)

1 Radiotherapy [megavoltage]
2 Control

5008 80Y Surgery: Entry JAN-1980 to OCT-1983 (406 patients were entered)

1 Mastectomy + Node Sampling + (Radiotherapy [selective] if N+)
2 Mastectomy + Node Clearance

5010 Breast Reconstruction (Chetty and Dean): Quality of Life Endpoint; Entry NOV-1978 to JUN-1980 (68 patients were entered; synthetic data only; no recurrence nor death information)

1 Immediate Breast Reconstruction
2 Delayed Breast Reconstruction (optional)

5011 85B1 Conservation Trial: Local Excision; Age < 71; ER < 20; Entry MAY-1985 to OCT-1991 (161 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6

5012 82T Surgery: Age < 70; Entry MAY-1982 to NOV-1983 (16 patients were entered; terminated early; synthetic data only; no recurrence information)

1 Local Excision
2 Mastectomy

5013 83P1 Conservation Trial - Original Protocol: Lumpectomy; ER < 20 mg/fmol protein; Entry NOV-1983 to MAR-1985 (52 patients were entered)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 Radiotherapy

5014 80Q Scottish/Guy's Trial A: Lumpectomy or Mastectomy; Axillary Clearance, or Sample and Radiotherapy; N+; Entry MAR-1980 to MAY-1990 (332 patients were entered; awaiting restoration of missing death information)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisolone
3 Oöphorectomy
4 Oöphorectomy + Prednisolone

5015 85E Trial E: Optional Optimal Local Surgery; Age 70+; Entry NOV-1985 to MAR-1991 (194 patients were entered)

1 Tamoxifen [20mg/d]
2 Tamoxifen [160mg] then Tamoxifen [20mg/d]

5016 Trial II: Inoperable Disease Subset; Age < 71; Entry JUL-1974 to AUG-1978 (48 patients were entered) {'reject'}

1 Radiotherapy
2 Radiotherapy + 5-Fluoro-Uracil × 1yr

5017 83P2 Conservation Trial - Original Protocol: Lumpectomy; ER?/(ER 20+ mg/fmol protein); Entry NOV-1983 to MAR-1985 (84 patients were entered)

1 Tamoxifen
2 Radiotherapy

5018 78D5 Scottish B: Second Randomisation from Tamoxifen; Postmenopausal; N+; Entry FEB-1985 to AUG-1989 (78 patients were entered)

1 Tamoxifen [10mg bd] × 5yr
2 Tamoxifen [10mg bd] indefinitely until recurrence

5019 78D6 Scottish C: Second Randomisation from Tamoxifen; N-; Entry MAR-1985 to NOV-1989 (240 patients were entered)

1 Tamoxifen [10mg bd] × 5yr
2 Tamoxifen [10mg bd] indefinitely until recurrence

5020 78D7 Scottish D: Second Randomisation from Tamoxifen; No Node Biopsy; Stage I-II; Age < 70; Entry JUN-1985 to NOV-1988 (24 patients were entered)

1 Tamoxifen [10mg bd] × 5yr
2 Tamoxifen [10mg bd] indefinitely until recurrence

5022 64D2 South-East Scotland Radiotherapy Trial: 'Ineligible' Patients (benign disease, not operated); Entry APR-1964 to MAR-1971 (510 patients were entered)

1 Radiotherapy + Simple Mastectomy
2 Radical Mastectomy

5023 85B2 Conservation Trial: Local Excision; Age < 71; ER 20+; Entry APR-1985 to AUG-1991 (428 patients were entered)

1 Tamoxifen [20mg/d] × 5yr
2 Radiotherapy + Tamoxifen [20mg/d] × 5yr

5024 Scottish B: Second Randomisation from Tamoxifen ('Exclusion' Sub-Set); Postmenopausal; N+; Entry MAY-1985 to JUL-1989 (18 patients were entered)

1 Tamoxifen [10mg bd] × 5yr
2 Tamoxifen [10mg bd] indefinitely until recurrence

5025 Scottish C: Second Randomisation from Tamoxifen ('Exclusion' Sub-Set); N-; Entry MAY-1985 to MAY-1990 (29 patients were entered)

1 Tamoxifen [10mg bd] × 5yr
2 Tamoxifen [10mg bd] indefinitely until recurrence

5026 Scottish D: Second Randomisation from Tamoxifen ('Exclusion' Sub-Set); No Node Biopsy; Stage I-II; Age < 70; Entry AUG-1984 to SEP-1987 (6 patients were entered)

1 Tamoxifen [10mg bd] × 5yr
2 Tamoxifen [10mg bd] indefinitely until recurrence

5027 93K SCTN-BR 9403: Entry 1993 ff. (not received)

1 Chemotherapy
2 Chemotherapy + Antioestrogen

5028 BASO II: Wide Local Excision; Entry ? (277 patients were entered by JUN-2000; not received)

1 Control
2 Radiotherapy and/or Tamoxifen

5029 Scottish CMF vs. Epirubicin Trial: Entry ? (326 patients were entered by 2000; not received)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 8
2 4-Epi-Doxorubicin × 4 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4

52 Saskatchewan Cancer Foundation, Canada {Bryant, Dietrich, Ewing, Krushen-Kosloski, Robson, Weir: APR-1995 (UPDATED NINE TIMES)}

5201 64A Prophylactic Oöphorectomy (Bryant and Weir): Premenopausal; Stage I-II; Entry JAN-1964 to OCT-1974 (379 patients were entered) {Potential problems from some premenopausal withdrawals and replacements}

1 Control
2 Oöphorectomy

53 National Kyushu Cancer Center, Japan {Nomura: DEC-1995 (REVISED VERSION, UPDATED TWICE)}

5301 78S1 NKCC: ER+; Premenopausal; Entry APR-1981 to DEC-1991 (402 patients were entered)

1 Mitomycin-C perioperative + Cyclophosphamide × 2yr
2 Mitomycin-C perioperative + Cyclophosphamide × 2yr + Tamoxifen [20mg/d] × 2yr
3 Tamoxifen [20mg/d] × 2yr + Oöphorectomy

5302 78S2 NKCC: ER+; Postmenopausal; Entry MAR-1981 to OCT-1991 (351 patients were entered)

1 Mitomycin-C perioperative + Cyclophosphamide × 2yr
2 Tamoxifen [20mg/d] × 2yr + Mitomycin-C perioperative + Cyclophosphamide × 2yr
3 Tamoxifen [20mg/d] × 2yr

5303 78S3 NKCC: ER-; Premenopausal; Entry NOV-1978 to DEC-1991 (329 patients were entered)

1 Mitomycin-C perioperative + Cyclophosphamide × 2yr
2 Tamoxifen [20mg/d] × 2yr + Mitomycin-C perioperative + Cyclophosphamide × 2yr

5304 78S4 NKCC: ER-; Postmenopausal; Entry SEP-1978 to NOV-1991 (318 patients were entered)

1 Mitomycin-C perioperative + Cyclophosphamide × 2yr
2 Tamoxifen [20mg/d] × 2yr + Mitomycin-C perioperative + Cyclophosphamide × 2yr

5305 78S5 NKCC: ER?; Entry SEP-1978 to NOV-1991 (79 patients were entered)

1 Mitomycin-C perioperative + Cyclophosphamide × 2yr
2 Tamoxifen [20mg/d] × 2yr + Mitomycin-C perioperative + Cyclophosphamide × 2yr

5306 78S6 NKCC: ER+; Premenopausal; Entry SEP-1978 to MAR-1981 (60 patients were entered)

1 Mitomycin-C perioperative + Cyclophosphamide × 2yr
2 Tamoxifen [20mg/d] × 2yr + Oöphorectomy

5307 78S7 NKCC: ER+; Postmenopausal; Entry SEP-1978 to MAR-1981 (52 patients were entered)

1 Mitomycin-C perioperative + Cyclophosphamide × 2yr
2 Tamoxifen [20mg/d] × 2yr

54 Alabama Breast Cancer Project, U.S.A. {Carpenter, Cloud, Conner, Maddox: OCT-1995 (UPDATED FIVE TIMES)}

5401 Chemotherapy: N+; Entry MAR-1975 to NOV-1978 (172 patients were entered; nonstandard randomisation) {note: although allocation was made by telephone it used the month of birth, the system being known by some clinicians}

1 Melphalan × 1yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr

5402 Surgery: Entry MAR-1975 to DEC-1978 (311 patients were entered; year-of-birth treatment allocation)

1 Modified Radical Mastectomy
2 Radical Mastectomy

56 Dublin, Ireland {Corcoran, Smith: AUG-1990 (UPDATED TWICE)}

5601 76D Edinburgh Primary Breast Trial: Entry SEP-1976 to DEC-1978 (41 patients were entered)

1 5-Fluoro-Uracil × 1yr
2 Control

57 ONCOFRANCE, Villejuif, France {Gil-Delgado, Itzhaki, Mathé, Misset, Di Palma, Sakek: OCT-1991 (REVISED VERSION, UPDATED)}

5701 78L1 ONCOFRANCE 1: N-; Groups 2 and 3 differed only by patient-dependent addition of A, and were merged and described as VCF; Entry MAR-1978 to APR-1981 (77 patients were entered) {Do not use until imbalanced allocation proportions are clarified}

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr
2 (Cyclophosphamide + 5-Fluoro-Uracil + Vincristine) × 1yr

5702 78L2 ONCOFRANCE 1: N+; Groups 2 and 3 differed only by patient-dependent addition of A, and were merged and described as AVCF; Entry MAR-1978 to JUN-1981 (251 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr
2 (Cyclophosphamide + 5-Fluoro-Uracil + Vincristine + Doxorubicin) × 1yr

5703 78L3 ONCOFRANCE 1: Second randomisation from CMF; Patients from 5701+5702; Entry MAR-1979 to MAY-1981 (96 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr + Bacillus Calmette-Guèrin

5704 78L4 ONCOFRANCE 1: Second randomisation from CFV; Patients from 5701; Entry MAR-1979 to APR-1981 (31 patients were entered)

1 (Cyclophosphamide + 5-Fluoro-Uracil + Vincristine) × 1yr
2 (Cyclophosphamide + 5-Fluoro-Uracil + Vincristine) × 1yr + Bacillus Calmette-Guèrin

5705 78L5 ONCOFRANCE 1: Second randomisation from CFVA; Patients from 5702; Entry FEB-1979 to JUN-1981 (70 patients were entered)

1 (Cyclophosphamide + 5-Fluoro-Uracil + Vincristine + Doxorubicin) × 1yr
2 (Cyclophosphamide + 5-Fluoro-Uracil + Vincristine + Doxorubicin) × 1yr + Bacillus Calmette-Guèrin

5706 81U1 ONCOFRANCE 2: N+; ER+; Entry DEC-1981 to OCT-1985 (not received)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil + Vincristine) × 6
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil + Vincristine) × 6 + Tamoxifen [30mg/d 15d/m] + Medroxyprogesterone Acetate [500mg/d 15d/m]

5707 81U2 ONCOFRANCE 2: N-/N+; ER-; Entry DEC-1981 to OCT-1985 (not received)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil + Vincristine) × 6
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil + Vincristine) × 6 + Etretinate [25mg/d] × 6m

5708 81U3 ONCOFRANCE 2: N+; ER?; Entry DEC-1981 to OCT-1985 (not received)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil + Vincristine) × 6
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil + Vincristine) × 6 + Etretinate [25mg/d] × 6m

58 Heidelberg and GABG, Germany {Bastert, Jonat, Kaufmann, Maass, von Minckwitz, Schumacher, Zander: JUN-2001 (SECOND REVISED VERSION, UPDATED TWICE)}

5801 79D1 GABG 1 (Kaufmann, von Minckwitz): Stage III; High Risk; N4+/(ER-, PR-); Age < 66; Entry JAN-1981 to MAY-1986 (478 patients were entered)

1 (Doxorubicin [30mg/m² iv d1] + Cyclophosphamide [300mg/m² iv d1,8]) q3wk × 8
2 (Doxorubicin [30mg/m² iv d1] + Cyclophosphamide [300mg/m² iv d1,8]) q3wk × 8 + Tamoxifen [10mg tid] × 2yr

5802 79D2 HD 2 (Kaufmann, von Minckwitz): Stage II; N-; Postmenopausal; Age < 73; Entry AUG-1979 to APR-1985 (136 patients were entered)

1 Control
2 Tamoxifen [10mg tid] × 2yr

5803 79D3 GABG 1 (Kaufmann, von Minckwitz): Stage II; Low Risk; N1-3; ER+/PR+; Age < 66; Entry FEB-1981 to APR-1986 (281 patients were entered)

1 Tamoxifen [10mg tid] × 2yr
2 (Cyclophosphamide [500mg/m² iv d1,8] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q4wk × 6

5804 76K HD 1 (Kaufmann, von Minckwitz): Adjuvant Chemotherapy; N+; Entry JUL-1976 to MAY-1979 (124 patients were entered)

1 Control
2 (Chlorambucil [5mg/d (<70kg) / 7·5mg/d (70+kg) d1-14] + 5-Fluoro-Uracil [500mg/d (<70kg) / 750mg/d (70+kg) d1,8,15]) q43d × 18

5805 87D1 GABG 3A. Modified Radical Mastectomy (Breast Conserving Therapy) (Jonat, Kaufmann, Maass & Bastert): Stage II; N1-9; Premenopausal; Entry JAN-1986 to AUG-1992 (586 patients were entered)

1 (Cyclophosphamide [500mg/m² iv d1,8] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q28d × 3 then Radiotherapy then (Cyclophosphamide [500mg/m² iv d1,8] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q28d × 3
2 (Cyclophosphamide [500mg/m² iv d1,8] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q28d × 3 then Radiotherapy

5806 87D2 GABG 3A. Modified Radical Mastectomy (Breast Conserving Therapy) (Jonat, Kaufmann, Maass & Bastert): Stage II; N1-9; Postmenopausal; ER-; PR-; Entry JAN-1986 to SEP-1992 (180 patients were entered)

1 (Cyclophosphamide [500mg/m² iv d1,8] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q28d × 3 then Radiotherapy then (Cyclophosphamide [500mg/m² iv d1,8] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q28d × 3
2 (Cyclophosphamide [500mg/m² iv d1,8] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q28d × 3 then Radiotherapy

5807 87D3 GABG 3B. Modified Radical Mastectomy (Breast Conserving Therapy) (Jonat, Kaufmann, Maass & Bastert): Stage II; N1-9; Postmenopausal; ER+/PR+; Entry NOV-1984 to OCT-1992 (526 patients were entered)

1 Radiotherapy then Tamoxifen [30mg/d] × 2yr
2 (Cyclophosphamide [500mg/m² iv d1,8] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q28d × 3 then Radiotherapy then (Cyclophosphamide [500mg/m² iv d1,8] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q28d × 3 + Tamoxifen [30mg/d] × 2yr

5808 87D4 GABG 3C (Jonat, Kaufmann, Maass & Bastert): Stage II; N10+; Premenopausal; ER+/PR+; Entry APR-1986 to SEP-1992 (86 patients were entered)

1 (Cyclophosphamide [600mg/m² iv d1] + 4-Epi-Doxorubicin [60mg/m² iv d1] + 5-Fluoro-Uracil [600mg/m² iv d1]) q28d × 6 + Tamoxifen [30mg/d] × 2yr
2 (Cyclophosphamide [500mg/m² iv d1,8] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q28d × 6 + Tamoxifen [30mg/d] × 2yr

5809 87D5 GABG 3C (Jonat, Kaufmann, Maass & Bastert): Stage II; N10+; Premenopausal; ER-; PR-; Entry AUG-1986 to JUN-1992 (34 patients were entered)

1 (Cyclophosphamide [600mg/m² iv d1] + 4-Epi-Doxorubicin [60mg/m² iv d1] + 5-Fluoro-Uracil [600mg/m² iv d1]) q28d × 6
2 (Cyclophosphamide [500mg/m² iv d1,8] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q28d × 6

5810 87D6 GABG 3C (Jonat, Kaufmann, Maass & Bastert): Stage II; N10+; Postmenopausal; Entry APR-1986 to NOV-1992 (168 patients were entered)

1 (Cyclophosphamide [600mg/m² iv d1] + 4-Epi-Doxorubicin [60mg/m² iv d1] + 5-Fluoro-Uracil [600mg/m² iv d1]) q28d × 6 + Tamoxifen [30mg/d] × 2yr
2 (Cyclophosphamide [500mg/m² iv d1,8] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q28d × 6 + Tamoxifen [30mg/d] × 2yr

5811 80P GABG 2 (Kaufmann, von Minckwitz): N-; Postmenopausal; Entry DEC-1980 to AUG-1990 (580 patients were entered)

1 Tamoxifen [10mg tid] × 2yr
2 Control

5812 93C1 GABG-4-A-93 (Kaufmann, Jonat): N0; ER+; Premenopausal; Entry 1993 ff. (677 patients were entered by DEC-1999; not received)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3
2 Goserelin × 2yr

5813 93C2 GABG-4-B-93 (Kaufmann, Jonat): N0-3; ER-; Premenopausal; Entry 1993 to 2000 (696 patients were entered to 5813-5814 by DEC-1999; not received)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 + Goserelin × 2yr

5814 93C3 GABG-4-B-93 (Kaufmann, Jonat): N4-9; ER-; Premenopausal; Entry 1993 to 2000 (696 patients were entered to 5813-5814 by DEC-1999; not received)

1 (Cyclophosphamide + 4-Epi-Doxorubicin) × 4 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3
2 (Cyclophosphamide + 4-Epi-Doxorubicin) × 4 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 + Goserelin × 2yr

5815 93C4 GABG-4-C-93 (Kaufmann, Jonat): N0-9; ER+; Postmenopausal; Age < 71; Entry 1993 ff. (not received)

1 Tamoxifen × 5yr
2 Tamoxifen × 5yr then 4-OHA × 3yr

5816 93C5 GABG-4-D-93 (Kaufmann, Jonat): N0-3; ER-; Postmenopausal; Age < 71; Entry 1993 to 2000 (764 patients were entered to 5816-5817 by DEC-1999; not received)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 + Tamoxifen × 5yr

5817 93C6 GABG-4-D-93 (Kaufmann, Jonat): N4-9; ER-; Postmenopausal; Age < 71; Entry 1993 to 2000 (764 patients were entered to 5816-5817 by DEC-1999; not received)

1 (Cyclophosphamide + 4-Epi-Doxorubicin) × 4 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3
2 (Cyclophosphamide + 4-Epi-Doxorubicin) × 4 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 + Tamoxifen × 5yr

5818 93C7 GABG-4-E-93 (Kaufmann, Jonat): N10+; Premenopausal; Entry 1993 to 2000 (385 patients were entered to 5818-5819 by DEC-1999; not received)

1 (Cyclophosphamide + 4-Epi-Doxorubicin) × 4 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 + Goserelin × 2yr
2 E-120 × 4 then Goserelin × 2yr

5819 93C8 GABG-4-E-93 (Kaufmann, Jonat): N10+; Postmenopausal; Age < 71; Entry 1993 to 2000 (385 patients were entered to 5818-5819 by DEC-1999; not received)

1 (Cyclophosphamide + 4-Epi-Doxorubicin) × 4 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 + Tamoxifen × 5yr
2 E-120 × 4 then Tamoxifen × 5yr

5820 93D GABG-4-G-93/IBCSG-10 (Kaufmann, Jonat): Tumour < 3cm; N0 clinical; Age 71+; Entry 1993 ff. (not received)

1 Mastectomy with Axillary Clearance + Tamoxifen × 5yr
2 Mastectomy + Tamoxifen × 5yr

5821 93E1 GABG-4/EH-93 (Zander): N10+; Premenopausal; Age < 56; Entry 1993 to 2000 (300 patients were entered to 5821-5822 by DEC-1999; not received)

1 (Cyclophosphamide + 4-Epi-Doxorubicin) × 4 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 + Goserelin × 2yr
2 (Cyclophosphamide + 4-Epi-Doxorubicin) × 4 then G-Colony Stimulating Factor then CTM + Stem Cell Transplantation

5822 93E2 GABG-4/EH-93 (Zander): N10+; Postmenopausal; Age < 56; Entry 1993 to 2000 (300 patients were entered to 5821-5822 by DEC-1999; not received)

1 (Cyclophosphamide + 4-Epi-Doxorubicin) × 4 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 + Tamoxifen × 5yr
2 (Cyclophosphamide + 4-Epi-Doxorubicin) × 4 then G-Colony Stimulating Factor then CTM + Stem Cell Transplantation

5823 79D4 HD 2 (Kaufmann, von Minckwitz): Stage II; N+; Postmenopausal; Age < 73; Entry OCT-1979 to JUL-1985 (59 patients were entered)

1 Tamoxifen [10mg tid] × 2yr
2 (Cyclophosphamide [500mg/m² iv d1,8] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q4wk × 6

5824 90F Zoladex Versus CMF (ZEBRA): Premenopausal; Stage II; N1-9; ER+; Age < 50; Entry 1990 to 2000 (1640 patients were entered; not received)

1 Goserelin × 2yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6

5825 ZEBRA Trial: Stage II; Age < 50; Entry 1990 ff. (nonexistent; not received)

1 Goserelin × 2yr
2 Goserelin × 5yr

5828 96G1 GABG-IMA(1): Stage III; N10+; Age < 50; Entry 1996 ff. (5 patients were entered by 1997; not received)

1 (4-Epi-Doxorubicin + Cyclophosphamide) × 3 then Chemotherapy [high-dose]
2 (4-Epi-Doxorubicin + Cyclophosphamide) × 3 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3

5829 96G2 GABG-IMA(2): Stage II; N10+; Age < 60; Entry 1996 ff. (10 patients were entered by 1997; not received)

1 (Etoposide + Ifosfamide + Cis-Platinum + 4-Epi-Doxorubicin) × 2 then Etoposide + Ifosfamide + Carboplatin
2 (4-Epi-Doxorubicin + Cyclophosphamide) × 4 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3

60 Israel Technion {Borovik, Robinson: JUN-1995 (UPDATED THREE TIMES)}

6001 Br-02-83: N+; Entry JUL-1983 to MAR-1985 (105 patients were entered; thought to be same trial as 4005; 'retired' pro temp.)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vinblastine + Doxorubicin

62 Ontario Cancer Treatment and Research Foundation, Canada {Clarke, Fetterley, Ryan: MAY-1995 (UPDATED FOUR TIMES)}

6201 68B Comparative Effect of Ovarian Irradiation in Carcinoma of the Breast: Postmenopausal; Entry JUL-1968 to JUN-1973 (332 patients were entered)

1 Control
2 Ovarian Irradiation

63 E.O.R.T.C. Breast Cancer Coöperative Group, Belgium {Bruning, Cooke, van Dongen, Lebesque, Mignolet, Nooij, Paridaens, Peterse, Piccart, Repelaer van Driel, Schueren, Sylvester, van de Velde, Welvaart: JUN-2000 (SECOND REVISED VERSION)}

6301 76E E.O.R.T.C. Trial 09771 (BCCG, DBCWP, Welvaart): N+; Entry OCT-1976 to NOV-1980 (452 patients were entered)

1 Control
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 2y

6302 76R E.O.R.T.C. Trial 10761 (BCCG, Paridaens): N+; Entry JUL-1976 to OCT-1980 (316 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr + Levamisole

6303 86A1 E.O.R.T.C. Trial 10854 (van de Velde): Stage I-II; Entry JUN-1986 to MAR-1991 (2402 patients were entered)

1 Control
2 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) perioperative

6304 80G E.O.R.T.C. Trial 10801 (BCCG, van Dongen): T1-2 N0-1; Stage I-II; Entry MAY-1980 to MAY-1986 (902 patients were entered; deliberate early 1:2 imbalance; N+ patients receive CMF and, for medially or centrally located tumours, parasternal radiotherapy)

1 Modified Radical Mastectomy
2 Lumpectomy and Axillary Clearance + Iridium [20Gy implant] + Radiotherapy [50Gy to breast]

6305 89N E.O.R.T.C. Trial 10882/22881 (BCCG, Schueren): T1-2 N0-1 M0; Breast Conservation; Entry 1989 ff. (5669 patients were entered; not received)

1 Radiotherapy [50Gy]
2 Radiotherapy [50Gy] + Radiotherapy [10-15Gy boost]

6307 91C E.O.R.T.C. Trial 10901: Entry MAR-1991 ff. (1845 patients were entered; not received)

1 Chemotherapy × 6 + Tamoxifen [20mg/d] × 3yr
2 Chemotherapy × 6

6308 91E E.O.R.T.C. Trial 10902: Entry 1991 ff. (698 patients were entered; not received)

1 Chemotherapy preoperative
2 Chemotherapy postoperative

6309 95C EORTC 10932: Complete Local Excision With Axillary Surgery; Age 50+; Entry JUN-1995 to MAR-1997 (874 patients were entered; not received)

1 Control
2 Radiotherapy [66Gy]

6310 86A2 E.O.R.T.C. Trial 10854 (van de Velde): Stage I-II; Premenopausal; N+; Entry JUN-1986 to JAN-1991 (393 patients were entered)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) perioperative then Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

6311 EORTC 10952: N+/(T2-3 N-); Entry ? (not received)

1 Tamoxifen
2 Tamoxifen + Fenretinide

65 Norwegian Radium Hospital, Oslo {Høst, Sjolie: SEP-2000 (REVISED VERSION)}

6501 64B X-Ray (Høst): Axillary Clearance; Entry JAN-1964 to DEC-1967 (552 patients were entered)

1 Ovarian Irradiation
2 Ovarian Irradiation + Radiotherapy [orthovoltage]

6502 64E Cobalt 60 (Høst): Axillary Clearance; Entry DEC-1967 to DEC-1972 (563 patients were entered)

1 Ovarian Irradiation + Radiotherapy [megavoltage]
2 Ovarian Irradiation

66 Dana-Farber Cancer Institute, Boston, U.S.A. {Gelman, Harris, Hayes, Henderson, Shapiro: JUL-1995 (UPDATED FIVE TIMES)}

6601 74D1 Adjuvant Breast 74-063 A (Henderson): Entry JUN-1974 to OCT-1974 (8 patients were entered) {note: original randomisation lists reviewed and all patients restored}

1 Control
2 (Cyclophosphamide + Doxorubicin) × 15wk
3 (Cyclophosphamide + Doxorubicin) × 30wk

6602 74D2 Adjuvant Breast 74-063 B (Henderson): N+; Entry DEC-1974 to FEB-1976 (32 patients were entered) {note: original randomisation lists reviewed and all patients restored}

1 Melphalan × 2yr
2 (Cyclophosphamide + Doxorubicin) × 15wk
3 (Cyclophosphamide + Doxorubicin) × 30wk

6603 74D3 Adjuvant Breast 75-122 A (Henderson): N0-3; Entry DEC-1975 to MAR-1985 (256 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 8m
2 (Methotrexate + 5-Fluoro-Uracil) × 6m

6604 74D4 Adjuvant Breast 75-122 B (Henderson): N4+; Entry DEC-1975 to FEB-1985 (268 patients were entered)

1 (Cyclophosphamide + Doxorubicin) × 15wk
2 (Cyclophosphamide + Doxorubicin) × 30wk

6605 84R Lumpectomy Trial (Harris): Axillary Dissection; Entry MAY-1984 to NOV-1992 (244 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Doxorubicin + P) × 4 then Radiotherapy
2 Radiotherapy then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Doxorubicin + P) × 4

6606 74D5 74-063/75-122 Second Randomisation (Henderson): Axillary Clearance; Entry MAR-1976 to OCT-1985 (218 patients were entered)

1 Control
2 Radiotherapy

67 London Northwick Park, U.K. {Kark, Kissin: JUN-1990 (UPDATED TWICE)}

6701 75G VCR + L-Pam versus Nil: Entry AUG-1975 to FEB-1980 (140 patients were entered)

1 Control
2 (Vincristine + Melphalan) × 1yr

68 Innsbruck University, Austria {Margreiter: SEP-1995 (UPDATED FOUR TIMES)}

6801 78H Austrian Tamoxifen Trial: ER+ Subset; Entry DEC-1978 to DEC-1981 (237 patients were entered) {only ER+ randomised, so ER- were excluded}

1 Tamoxifen [10mg bd] × 1yr
2 Control

70 British Columbia Cancer Agency, Vancouver, Canada {Baird, Jackson, Ragaz: SEP-2000 (SIXTH REVISED VERSION)}

7001 78G1 B.C.C.A. G1 Adjuvant Breast Trial (Ragaz and Jackson): Premenopausal; Axillary Clearance; N+; Entry SEP-1978 to MAY-1986 (318 patients were entered)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Radiotherapy
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

7002 78G2 B.C.C.A. G1 Adjuvant Breast Trial (Ragaz and Jackson): Second Randomisation; Premenopausal; Axillary Clearance; ER+; N+; Entry SEP-1978 to OCT-1984 (134 patients were entered)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Ovarian Irradiation + Prednisone × 2yr
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

7004 83L1 Preoperative Neoadjuvant Randomised Study (Ragaz and Baird): Low Risk; N-; Entry MAR-1983 to MAY-1990 (123 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1 preoperative + Radiotherapy
2 Radiotherapy

7005 83L2 Preoperative Neoadjuvant Randomised Study (Ragaz and Baird): High Risk; N+; Entry FEB-1983 to JUL-1990 (81 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1 preoperative then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) q1m × 8 postoperative + Radiotherapy
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) q1m × 9 postoperative + Radiotherapy

71 Western Cancer Study Group, U.S.A. {Chlebowski: JUN-2000 (UPDATED FIVE TIMES)}

7101 74F1 WCG-146 Phase III Study: N4+; Entry NOV-1974 to MAY-1976 (40 patients were entered)

1 5-Fluoro-Uracil [high dose] × 1yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) [high dose] × 1yr

7102 74F2 WCG-146 Phase III Study: N4+; Entry OCT-1974 to NOV-1976 (22 patients were entered)

1 Radiotherapy then 5-Fluoro-Uracil [low dose] × 1yr
2 Radiotherapy then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) [low dose] × 1yr

72 Michigan, U.S.A. {Kerry: 6-AUG-1985}

7201 "Randomisation based on willingness to participate": Postmenopausal; N+; Entry JAN-1975 to MAY-1985 (40 patients were entered)

1 Adjuvant
2 Disseminated
3 Control

73 Evanston Hospital, Illinois, U.S.A. {Scanlon: SEP-1995 (REVISED VERSION)}

7301 75F1 N.C.I. Contract No. N01-CB-53917, Adjuvant Chemotherapy for Stage II-III Disease: N+; Entry JUN-1975 to OCT-1977 (115 patients were entered)

1 Melphalan × 1yr
2 (Cyclophosphamide + 5-Fluoro-Uracil + Prednisone) × 1yr
3 (Cyclophosphamide + 5-Fluoro-Uracil + Prednisone) × 1yr + Bacillus Calmette-Guèrin

7302 75F2 N.C.I. Contract No. N01-CB-53917, Adjuvant Chemotherapy for Stage II-III Disease: N+; Entry NOV-1977 to JUN-1979 (81 patients were entered)

1 (Cyclophosphamide + 5-Fluoro-Uracil + Prednisone) × 1yr
2 (Cyclophosphamide + 5-Fluoro-Uracil + Prednisone) × 1yr + Bacillus Calmette-Guèrin

75 Eastern Coöperative Oncology Group, U.S.A. {Abeloff, Carbone, Cummings, Davidson, Davis, Falkson, Gilchrist, Gray, LeMaistre, Mansour, Olson, Robert, Roseman, Tallman, Taylor, Tormey, Vaughan, Wood: FEB-2000 (FOURTH REVISED VERSION)}

7501 78J EST 1178: Postmenopausal; Age 66+; Stage II; N+; Entry SEP-1978 to FEB-1982 (181 patients were entered)

1 Control
2 Tamoxifen [10mg bd] × 2yr

7502 78V1 EST 5177: Premenopausal; Stage II; N+; Entry MAR-1978 to FEB-1982 (662 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisone) × 1yr
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisone) × 1yr + Tamoxifen [10mg bd] × 1yr

7503 78V2 EST 6177: Postmenopausal; Age < 66; Stage II; N+; Entry MAR-1978 to JUL-1981 (265 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisone) × 1yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisone) × 1yr + Tamoxifen [10mg bd] × 1yr
3 Control

7504 82D1 EST 5181: Premenopausal; N+; Entry MAR-1982 to JUN-1987 (658 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisone + Tamoxifen [20mg/d]) × 12
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisone + Tamoxifen [20mg/d] + Halotestin then Triethylenephosphoramide + Doxorubicin + Vinblastine + Tamoxifen + Halotestin) × 12

7505 82D2 EST 5181: Second Randomisation; Premenopausal; N+; Entry DEC-1982 to JAN-1989 (478 patients were entered)

1 Tamoxifen [20mg/d] × 1yr
2 Tamoxifen [20mg/d] × 5yr

7506 82D3 EST 4181: Phase III Adjuvant Therapy; Postmenopausal; N+; Entry MAR-1982 to DEC-1986 (962 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisone + Tamoxifen) × 12 then Tamoxifen to 5yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisone + Tamoxifen) × 12
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisone + Tamoxifen) × 4

7507 81H EST 1180 = INT 0011 = SWOG 8294: N-; Entry JUL-1981 to MAR-1988 (541 patients were entered)

1 Control
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisone) × 6

7508 82Q EST 3181 (Olson): Locally Advanced; Axillary Clearance; N+; Entry JUL-1982 to SEP-1987 (332 patients were entered)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil + Tamoxifen [20mg/d po] + Halotestin) × 6m then Radiotherapy [megavoltage]
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil + Tamoxifen [20mg/d po] + Halotestin) × 6m

7509 82D4 EST 5181: Third Randomisation; Premenopausal; N+; Entry MAY-1987 to AUG-1992 (107 patients were entered)

1 Tamoxifen [20mg/d] × 5yr
2 Tamoxifen [20mg/d] indefinitely

7510 82D5 EST 4181: Second Randomisation; Postmenopausal; N+; Entry APR-1987 to JAN-1992 (87 patients were entered)

1 Tamoxifen [20mg/d] × 5yr
2 Tamoxifen [20mg/d] indefinitely

7511 89F EST 5188: Premenopausal; N+; ER+; Entry AUG-1989 to FEB-1994 (1536 patients were entered)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6 then Goserelin × 5yr
3 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6 then (Goserelin + Tamoxifen [20mg/d]) × 5yr

7512 89G EST 3189 = INT 0108: Premenopausal/Postmenopausal; N+; ER-; Entry SEP-1989 to APR-1993 (646 patients were entered)

1 Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil + Vincristine + Methotrexate + Folinic Acid) × 16wk

7513 91L1 EST 2190 = INT 0121 (Tallman): Early-Stage Breast Cancer; N10+; ER-; Entry AUG-1991 ff. (377 patients were entered into 7513+7514 by MAY-1996; target 536; not received)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6 then Radiotherapy
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6 then Cyclophosphamide [6g/m² over 4d iv] + Triethylenephosphoramide [800mg/m² over 4d iv] then (Autologous Stem Cell Transplantation / Autologous Bone Marrow Transplant) then Radiotherapy

7514 91L2 EST 2190 = INT 0121 (Tallman): Early-Stage Breast Cancer; N10+; ER+; Entry AUG-1991 ff. (377 patients were entered into 7513+7514 by MAY-1996; target 536; not received)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6 then Radiotherapy + Tamoxifen
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6 then Cyclophosphamide [6g/m² over 4d iv] + Triethylenephosphoramide [800mg/m² over 4d iv] then (Autologous Stem Cell Transplantation / Autologous Bone Marrow Transplant) then Radiotherapy + Tamoxifen

7515 96H1 EST 2193: Postmenopausal; History of N- Breast Cancer; No Hysterectomy; Taking Tamoxifen; Entry 1996 ff. (not received)

1 Tamoxifen
2 Tamoxifen + Medroxyprogesterone Acetate

7516 96H2 EST 2193: Postmenopausal; History of N- Breast Cancer; Hysterectomy; Taking Tamoxifen; Entry 1996 ff. (not received)

1 Tamoxifen
2 Tamoxifen + Ogen

7517 96J Phase III Fenretinide Trial: N+; Postmenopausal; ER+; PR+; Entry 1996 ff. (supersedes 16506; not received)

1 Tamoxifen [20mg/d]
2 Tamoxifen [20mg/d] + Fenretinide [400mg/d, 3d holiday per month]

76 International Breast Cancer Study Group (Ludwig), Bern, Switzerland {Castiglione, Coates, Forbes, Gelber, Goldhirsch, Price, Rudenstam, Thürlimann: APR-2001 (THIRD REVISED VERSION, UPDATED)}

7601 78K3 IBCSG/Ludwig Trial III (Forbes): Postmenopausal; N+; Age < 66; Entry JUL-1978 to AUG-1981 (503 patients were entered)

1 Control
2 Prednisone [low dose] + Tamoxifen [20mg od] × 1yr
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisone [low dose]) × 1yr + Tamoxifen [20mg od] × 1yr

7602 78K4 IBCSG/Ludwig Trial IV (Castiglione): Postmenopausal; N+; Age 66-80; Entry JUL-1978 to AUG-1981 (349 patients were entered)

1 Control
2 Prednisone [low dose] + Tamoxifen [20mg od] × 1yr

7603 78K1 IBCSG/Ludwig Trial I (Goldhirsch and Gelber): Premenopausal/Perimenopausal; N1-3; Entry JUL-1978 to AUG-1981 (505 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisone [low dose]) × 1yr

7604 78K2 IBCSG/Ludwig Trial II (Coates): Premenopausal/Perimenopausal; N4+; Entry JUL-1978 to AUG-1981 (356 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisone [low dose]) × 1yr
2 Oöphorectomy then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisone [low dose]) × 1yr

7605 81F1 IBCSG/Ludwig Trial V (Gelber): Premenopausal; N+; Entry NOV-1981 to DEC-1985 (715 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Folinic Acid) × 1 perioperative
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Folinic Acid) × 1 perioperative then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisone [low dose]) × 6m
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisone [low dose]) × 6m

7606 81F2 IBCSG/Ludwig Trial V (Gelber): Postmenopausal; N+; Entry NOV-1981 to DEC-1985 (514 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Folinic Acid) × 1 perioperative
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Folinic Acid) × 1 perioperative then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisone [low dose]) × 6m + Tamoxifen [20mg/d]
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Prednisone [low dose]) × 6m + Tamoxifen [20mg/d]

7607 81F3 IBCSG/Ludwig Trial V (Gelber): N-; 1:2 Randomisation; Entry NOV-1981 to DEC-1985 (1275 patients were entered)

1 Control
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Folinic Acid) × 1 perioperative

7608 86H1 IBCSG Trial VI (Goldhirsch): Premenopausal/Perimenopausal; N+; Entry JUL-1986 to APR-1993 (1554 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1m at m9, m12, m15
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3m
4 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3m then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1m at m6, m9, m12

7609 86H2 IBCSG Trial VII (Rudenstam): Postmenopausal; N+; Entry JUL-1986 to APR-1993 (1266 patients were entered)

1 Tamoxifen × 5yr
2 Tamoxifen × 5yr + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1m at m9, m12, m15
3 Tamoxifen × 5yr + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3m
4 Tamoxifen × 5yr + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3m then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1m at m9, m12, m15

7610 88D IBCSG Trial IX (Castiglione, Gelber and Goldhirsch): Postmenopausal; N-; Entry OCT-1988 to JUL-1999 (1715 patients were entered)

1 Tamoxifen [20mg/d] × 5yr
2 (Cyclophosphamide [100mg/m²/d po d1-14] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) × 3m then Tamoxifen × 57m [20mg/d]

7614 90S1 IBCSG Trial VIII 4-Way (Gelber and Goldhirsch): Premenopausal; N-; Entry MAR-1990 to 1-APR-1992 (200 patients were entered; not received)

1 Control
2 (Cyclophosphamide [100mg/m²/d po d1-14] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) × 6m
3 Goserelin × 2yr
4 (Cyclophosphamide [100mg/m²/d po d1-14] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) × 6m then Goserelin × 18m

7615 90S2 IBCSG Trial VIII 3-Way (Gelber and Goldhirsch): Premenopausal; N-; Entry 2-APR-1992 to 1999 (911 patients were entered; not received)

1 (Cyclophosphamide [100mg/m²/d po d1-14] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) × 6m
2 Goserelin × 2yr
3 (Cyclophosphamide [100mg/m²/d po d1-14] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) × 6m then Goserelin × 18m

7616 93L IBCSG Trial 10-93: Elderly; Entry 1993 ff. (414 patients were entered by JAN-2000; not received)

1 Axillary Clearance then Tamoxifen × 5yr
2 No Axillary Clearance then Tamoxifen × 5yr

7617 93H IBCSG Trial 11-93 (Thürlimann): Premenopausal; N+; Suitable for Endocrine Therapy Alone; Entry JUN-1993 to OCT-1998 (174 patients were entered)

1 Ovarian Ablation + Tamoxifen × 5yr
2 Ovarian Ablation then (Doxorubicin + Cyclophosphamide) × 4 then Tamoxifen × 5yr

7618 93M1 IBCSG Trial 12a-93: Perimenopausal/Postmenopausal; N+; Suitable for Endocrine Therapy Alone; Entry MAY-1993 to JAN-1997 (154 patients were entered; not received)

1 (Doxorubicin + Cyclophosphamide) × 4 + Tamoxifen × 5yr (concurrent)
2 (Doxorubicin + Cyclophosphamide) × 4 then Tamoxifen × 5yr sequential
3 Tamoxifen × 5yr
4 (Doxorubicin + Cyclophosphamide) × 4 + Toremifene × 5yr (concurrent)
5 (Doxorubicin + Cyclophosphamide) × 4 then Toremifene × 5yr sequential
6 Toremifene × 5yr

7619 93N IBCSG 13-93: Premenopausal; N+; Not Suitable for Endocrine Therapy Alone; Entry 1993 to AUG-1999 (1294 patients were entered; not received)

1 (Doxorubicin + Cyclophosphamide) × 4 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3
2 (Doxorubicin + Cyclophosphamide) × 4 then 16wk off-treatment then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3
3 (Doxorubicin + Cyclophosphamide) × 4 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 then Tamoxifen × 5yr
4 (Doxorubicin + Cyclophosphamide) × 4 then 16wk off-treatment then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 then Tamoxifen × 5yr

7620 93P IBCSG 14-93: Perimenopausal/Postmenopausal; N+; Not Suitable for Endocrine Therapy Alone; Entry 1993 to AUG-1999 (969 patients were entered; not received)

1 (Doxorubicin + Cyclophosphamide) × 4 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 then Tamoxifen/Toremifene × 5yr
2 (Doxorubicin + Cyclophosphamide) × 4 then 16wk off-treatment then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 then Tamoxifen/Toremifene × 5yr

7621 93Q IBCSG 15-95: N10+/(ER-, N5+)/(N5+, T3); Age < 65; Entry 1995 to MAR-2000 (344 patients were entered; not received)

1 (4-Epi-Doxorubicin/Doxorubicin + Cyclophosphamide) × 4 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 then Tamoxifen × 5yr
2 PBPC Support + (4-Epi-Doxorubicin + Cyclophosphamide) [high dose] × 4 then Tamoxifen × 5yr

7622 93M2 IBCSG Trial 12b-93: Centres with No Access to Toremifene; Perimenopausal/Postmenopausal; N+; Suitable for Endocrine Therapy Alone; Entry MAY-1993 to JAN-1997 (59 patients were entered; not received)

1 (Doxorubicin + Cyclophosphamide) × 4 + Tamoxifen × 5yr (concurrent)
2 (Doxorubicin + Cyclophosphamide) × 4 then Tamoxifen × 5yr sequential
3 Tamoxifen × 5yr

7623 93M3 IBCSG Trial 12c-93: Perimenopausal/Postmenopausal; N+; Suitable for Endocrine Therapy Alone; Entry FEB-1997 to AUG-1999 (239 patients were entered; not received)

1 Tamoxifen × 5yr
2 Toremifene × 5yr

77 Mayo Clinic, U.S.A. {Ahmann, Ingle, Moertel, O'Fallon, Suman, Wieand: JUN-2000 (FOURTH REVISED VERSION)}

7701 73C1 Mayo Clinic Breast Surgical Adjuvant Protocol 70-56-32 4-way (Ahmann): Axillary Clearance; N+; Entry JUL-1973 to NOV-1974 (34 patients were entered)

1 (Cyclophosphamide + 5-Fluoro-Uracil + Prednisone) × 1yr
2 Radiotherapy [megavoltage] + (Cyclophosphamide + 5-Fluoro-Uracil + Prednisone) × 1yr
3 Control
4 Radiotherapy [megavoltage]

7702 73C2 Mayo Clinic Breast Surgical Adjuvant Protocol 70-56-32 3-way (Ahmann): Postmenopausal; Axillary Clearance; N+; Entry DEC-1974 to SEP-1980 (192 patients were entered)

1 Melphalan × 1yr
2 (Cyclophosphamide + 5-Fluoro-Uracil + Prednisone) × 1yr
3 Radiotherapy [megavoltage] + (Cyclophosphamide + 5-Fluoro-Uracil + Prednisone) × 1yr

7703 73C3 Mayo Clinic Breast Surgical Adjuvant Protocol 70-56-32 3-way (Ahmann): Premenopausal; Axillary Clearance; N+; Entry DEC-1974 to SEP-1977 (53 patients were entered)

1 Melphalan × 1yr
2 (Cyclophosphamide + 5-Fluoro-Uracil + Prednisone) × 1yr
3 Radiotherapy [megavoltage] + (Cyclophosphamide + 5-Fluoro-Uracil + Prednisone) × 1yr

7704 73C4 Mayo Clinic Breast Surgical Adjuvant Protocol 70-56-32 2-way (Ahmann): Premenopausal; Axillary Clearance; N+; Entry NOV-1977 to AUG-1980 (49 patients were entered)

1 (Cyclophosphamide + 5-Fluoro-Uracil + Prednisone) × 1yr
2 Radiotherapy [megavoltage] + (Cyclophosphamide + 5-Fluoro-Uracil + Prednisone) × 1yr

7705 78M1 Protocol NCCTG/Mayo-77-30-51 (Ingle): Premenopausal; Age < 76; Entry MAR-1978 to FEB-1986 (432 patients were entered)

1 (Cyclophosphamide + 5-Fluoro-Uracil + Prednisone) × 10
2 (Cyclophosphamide + 5-Fluoro-Uracil + Prednisone) × 10 + Tamoxifen [10mg bd] × 1yr

7706 78M2 Protocol NCCTG/Mayo-77-30-51 2-Way (Ingle): Postmenopausal; Age < 76; Entry MAR-1978 to APR-1979 (36 patients were entered)

1 (Cyclophosphamide + 5-Fluoro-Uracil + Prednisone) × 10
2 (Cyclophosphamide + 5-Fluoro-Uracil + Prednisone) × 10 + Tamoxifen [10mg bd] × 1yr

7707 78M3 Protocol NCCTG/Mayo-77-30-51 3-Way (Ingle): Postmenopausal; Age < 76; Entry MAY-1979 to AUG-1985 (261 patients were entered)

1 (Cyclophosphamide + 5-Fluoro-Uracil + Prednisone) × 10
2 (Cyclophosphamide + 5-Fluoro-Uracil + Prednisone) × 10 + Tamoxifen [10mg bd] × 1yr
3 Control

7708 E-PBT01 Intergroup: Phase III; Metastatic Breast Cancer, Responding after 4-6 Courses Induction Chemotherapy; Age 18-60; Entry ? (not received)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 24m
2 Cyclophosphamide + Triethylenephosphoramide + Carboplatin then Autologous Bone Marrow Transplant + Peripheral Stem Cell Rescue

78 Heidelberg, Germany {Herfarth, Scheurlen: AUG-1991 (REVISED VERSION, UPDATED TWICE)}

7801 69A Heidelberg Radiotherapy Trial: Axillary Clearance; Entry JUN-1969 to MAY-1972 (143 patients were entered) {Imbalance in group sizes is reported to be due merely to an unusual run in the random number table used}

1 Radiotherapy [megavoltage]
2 Control

82 Glasgow W.S.S.A., Scotland {Ferguson, Litton: JUL-1987 (UPDATED)}

8201 72A W.S.S.A. Breast Survey: Axillary Clearance; Entry FEB-1972 to FEB-1977 (335 patients were entered; 1985 overview data only)

1 Simple Mastectomy + flap Radiotherapy [42Gy orthovoltage]
2 Simple Mastectomy + flap Radiotherapy [42Gy orthovoltage] + axillary Radiotherapy [42Gy megavoltage]
3 Total Mastectomy + flap Radiotherapy [42Gy orthovoltage]

83 Cancer and Leukaemia Group B, U.S.A. {Cirrincione, Crump, Korzun, Peters, Shpall, Wood: MAR-2001 (FOURTH REVISED VERSION, UPDATED)}

8301 75B1 C.A.L.G.B. Study 7581: N+; Entry JUN-1975 to OCT-1978 (560 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + P) × 1yr then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 2yr
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr + Bacillus Calmette-Guèrin then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr

8302 75B2 C.A.L.G.B. Study 7581: N+; Entry OCT-1978 to JAN-1981 (346 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + P) × 1yr then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 2yr

8303 80R1 C.A.L.G.B. Study 8082: First Randomisation; N+; Age < 76; Entry OCT-1980 to AUG-1984 (945 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + Prednisone) × 8wk then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + Prednisone) q4wk × 6
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + Prednisone) × 8wk then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + Prednisone) q6wk × 2

8304 80R2 C.A.L.G.B. Study 8082: Second Randomisation from (CMFVP × 8wk; q4wk × 6); N+; Entry MAR-1981 to MAR-1985 (383 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + Prednisone) q4wk × 6
2 (Vinblastine + Doxorubicin + Triethylenephosphoramide + Halotestin + Fluoxymesterone) q4wk × 6

8305 80R3 C.A.L.G.B. Study 8082: Second Randomisation from (CMFVP × 8wk; q6wk × 2); N+; Entry OCT-1980 to APR-1985 (361 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + Prednisone) q6wk × 2
2 (Vinblastine + Doxorubicin + Triethylenephosphoramide + Halotestin + Fluoxymesterone) q4wk × 6

8306 78N C.A.L.G.B. Study CLB-7784 (Frei): Stage III; Age < 75; Entry DEC-1978 ff. (87 patients were entered; synthetic data only; no recurrence information)

1 Surgery + (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil + V + P) / (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + V + P)
2 Radiotherapy + (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil + V + P) / (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + V + P)

8307 85A C.A.L.G.B. Study CLB-8541 (Budman): Stage II; N+; Entry JAN-1985 to MAR-1991 (1572 patients were entered)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) [low dose] × 4m
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) [standard dose] × 6m
3 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) [high dose] × 4m

8308 91G1 C.A.L.G.B. Study 9082 (Intergroup 0163): ER-; Entry APR-1991 to AUG-1998 (323 patients were entered)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 4 + Autologous Bone Marrow Transplant + Cyclophosphamide + Cis-Platinum + Carmustine + G-Colony Stimulating Factor + Radiotherapy
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 4 + Cyclophosphamide + Cis-Platinum + Carmustine + G-Colony Stimulating Factor + Radiotherapy

8309 91G2 C.A.L.G.B. Study 9082 (Intergroup 0163): ER+; Entry APR-1991 to AUG-1998 (462 patients were entered)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 4 + Autologous Bone Marrow Transplant + Cyclophosphamide + Cis-Platinum + Carmustine + G-Colony Stimulating Factor + Radiotherapy + Tamoxifen
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 4 + Cyclophosphamide + Cis-Platinum + Carmustine + G-Colony Stimulating Factor + Radiotherapy + Tamoxifen

8310 89S1 SWOG 8814: N+; Postmenopausal; Entry 1989/1990 (duplicated as 1208; not received)

1 Tamoxifen × 5yr
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6 then Tamoxifen × 5yr
3 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6 + Tamoxifen × 5yr

8311 ECOG EST5188: Premenopausal; N+; ER+; Entry 1989 ff. (duplicated as 7511; not received)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6 then Goserelin × 5yr
3 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6 then (Tamoxifen + Goserelin) × 5yr

8312 89S2 ECOG EST3189: N+; ER-; Premenopausal/Postmenopausal; Entry 1989/1990 (duplicated as 7512; not received)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) q28d × 6
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Doxorubicin + V) q14d × 8

8313 89S3 SWOG 8897: High Risk; N-; Premenopausal/Postmenopausal; Entry 1989/1990 (duplicated as 1210; not received)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 then Tamoxifen × 5yr
3 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6
4 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6 then Tamoxifen × 5yr

8314 C.A.L.G.B. Study 9082 (Intergroup 0163): Operable Breast Cancer; N10+; Entry APR-1991 to AUG-1998 (785 patients were entered; not randomised)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 4 then (Cyclophosphamide + Cis-Platinum + Carmustine) [high dose]
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 4 then (Cyclophosphamide + Cis-Platinum + Carmustine) [outpatient dose]

8315 94C C.A.L.G.B. Study 9343: Age 71+; Tumour < 4cm; N-; Entry 1994 ff. (647 patients were entered; not received)

1 Lumpectomy + Breast Irradiation + Tamoxifen [20mg/d] × 5yr
2 Lumpectomy + Tamoxifen [20mg/d] × 5yr

8316 94D C.A.L.G.B. Study 9344: N+; Entry MAY-1994 to APR-1997 (3170 patients were entered)

1 (Cyclophosphamide [600mg/m²] + Doxorubicin [60mg/m²]) q3wk × 4
2 (Cyclophosphamide [600mg/m²] + Doxorubicin [75mg/m²]) q3wk × 4
3 (Cyclophosphamide [600mg/m²] + Doxorubicin [90mg/m²]) q3wk × 4
4 (Cyclophosphamide [600mg/m²] + Doxorubicin [60mg/m²]) q3wk × 4 then Paclitaxel [175mg/m²] q3wk × 4
5 (Cyclophosphamide [600mg/m²] + Doxorubicin [75mg/m²]) q3wk × 4 then Paclitaxel [175mg/m²] q3wk × 4
6 (Cyclophosphamide [600mg/m²] + Doxorubicin [90mg/m²]) q3wk × 4 then Paclitaxel [175mg/m²] q3wk × 4

85 Glasgow Victoria Infirmary, Scotland {McArdle, Smith: AUG-1995 (UPDATED THRICE)}

8501 76C Victoria-Gartnavel Study: Axillary Clearance; N+; Entry JUN-1976 to JAN-1983 (322 patients were entered) {pre-randomisation imbalances are only moderately significant}

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr
2 Radiotherapy [orthovoltage] + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr
3 Radiotherapy [orthovoltage]

86 Berlin-Buch Akademie der Wissenschaften der D.D.R. {Berndt, Granetzny, Peek, Schön: MAY-1990 (UPDATED TWICE)}

8601 74A1 Berlin-Buch A.I.C.H.T. Trial in High Risk Breast Cancer: N+; (ER+, Premenopausal/Perimenopausal - oöphorectomy + nortestosterone; ER+ Postmenopausal, - nortestosterone); 1:1 Randomisation; Entry JAN-1974 to MAY-1978 (110 patients were entered)

1 Control (Chemotherapy on distant relapse)
2 (Chemotherapy or Tamoxifen) × 2yr, using one or more agents selected in light of in vitro pre-randomisation drug-sensitivity tests

8602 74A2 Berlin-Buch A.I.C.H.T. Trial in High Risk Breast Cancer: N+; (ER+, Premenopausal/Perimenopausal - oöphorectomy + nortestosterone; ER+, Postmenopausal - nortestosterone); 1:2 Randomisation; Entry MAY-1978 to MAR-1981 (90 patients were entered)

1 Control (Chemotherapy on distant relapse)
2 (Chemotherapy or Tamoxifen) × 2yr, using one or more agents selected in light of in vitro pre-randomisation drug-sensitivity tests

8603 62B1 ABC Trial (Peek): Rotter-Halsted Mastectomy; Axillary Clearance; Stage I-III; Entry JUN-1962 to SEP-1972 (380 patients were entered) {need clinical nodal status}

1 Control
2 Cyclophosphamide
3 Radiotherapy preoperative (megavoltage, except 16 patients orthovoltage)

8604 62B2 ab Trial (Peek): Rotter-Halsted Mastectomy; Stage I-III; Entry JUL-1964 to FEB-1974 (186 patients were entered)

1 Control
2 Cyclophosphamide

8605 76Q1 Medial Quadrant (MQ) Localised Lesions Stage I-II (Peek): Entry JAN-1976 to MAR-1981 (103 patients were entered)

1 Radical Mastectomy + Peripheral Radiotherapy
2 Extended Radical Mastectomy

8606 82U Inflammatory Breast Cancer: Entry MAY-1982 to DEC-1986 (38 patients were entered; synthetic data only; no recurrence information)

1 (Cyclophosphamide + Methotrexate + Ftorafur) preoperative then Cyclophosphamide + Methotrexate + Ftorafur
2 (Ftorafur + Doxorubicin + Cyclophosphamide) × 3 preoperative then Cyclophosphamide + Methotrexate + Ftorafur

8607 Chemotherapy and Surgery Trial: N1-6; Entry JUN-1982 ff. (131 patients were entered; synthetic data only; no recurrence information; missing patients - nonstandard randomisation)

1 Partial Mastectomy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 + Doxorubicin (some cases)
2 Radical Mastectomy

8608 76Q2 CMEA Multicentre Trial: Lateral Quadrant (LQ) Localised Breast Lesions; Stage I-II; Entry FEB-1976 to JUL-1980 (163 patients were entered)

1 Rotter-Halsted Mastectomy
2 Modified Radical (Patey) Mastectomy

87 St Petersburg Petrov Research Institute of Oncology, Russia {Barash, Ivanov, Ivanova, Semiglazov, Topuzov: JUN-2001 (REVISED VERSION, UPDATED SEVEN TIMES)}

8701 75J1 I/II: Entry JAN-1975 to DEC-1979 (615 patients were entered; nonstandard randomisation)

1 Control
2 Triethylenephosphoramide
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) / (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil) sometimes

8702 75J2 IIIA: N+; Entry JAN-1975 to DEC-1979 (328 patients were entered; nonstandard randomisation)

1 Triethylenephosphoramide
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) / (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil) sometimes

8703 75J3 I: N-; Entry JAN-1979 to DEC-1982 (83 patients were entered; nonstandard randomisation)

1 Control
2 Triethylenephosphoramide
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) / (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil) sometimes

8704 75J4 (a) II: Entry JAN-1979 to NOV-1982 (86 patients were entered; nonstandard randomisation)

1 Triethylenephosphoramide
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) / (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil) sometimes

8705 75J5 (b) III: N+; Entry JAN-1979 to NOV-1982 (201 patients were entered; nonstandard randomisation)

1 Triethylenephosphoramide
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) / (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil) sometimes

8706 82S1 (a): Premenopausal; Entry FEB-1982 to DEC-1984 (136 patients were entered; nonstandard randomisation; 13 patients incorrectly moved from 'treatment' to 'control')

1 Control
2 Tamoxifen [10mg bd] × 1yr

8707 82S2 (b): Postmenopausal; Entry JAN-1982 to DEC-1984 (116 patients were entered; nonstandard randomisation)

1 Control
2 Tamoxifen [10mg bd] × 1yr
3 Diethylstilboestrol/Synestrol × 6m

8708 85J1 Chemo/Hormonotherapy Trial: Stage I-IIa; Premenopausal/Perimenopausal; Patey Mastectomy or Sectoral Resection; Entry JAN-1985 to DEC-1989 (301 patients were entered)

1 Control
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4 then (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil) × 2
3 Tamoxifen [10mg bd] × 1yr
4 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4 then (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil) × 2 + Tamoxifen [10mg bd] × 1yr

8709 85J2 Tamoxifen and Synestrol Trial: Stage I-IIa; T1-2 N0; Postmenopausal; Patey Mastectomy; Entry JAN-1985 to DEC-1989 (236 patients were entered)

1 Control
2 Tamoxifen [10mg bd] × 1yr
3 Diethylstilboestrol/Synestrol × 6m

8710 85J3 Tamoxifen and CMF Trial: Stage IIb; T1-2 N1; Premenopausal; Modified Halsted Mastectomy; Entry FEB-1985 to DEC-1989 (126 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4 then (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil) × 2
2 Tamoxifen [10mg bd] × 1yr
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4 then (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil) × 2 + Tamoxifen [10mg bd] × 1yr

8711 85J4 Tamoxifen Versus Synestrol Trial: Stage IIb; T1-2 N1; Postmenopausal; Modified Halsted Mastectomy; Entry FEB-1985 to DEC-1989 (48 patients were entered)

1 Tamoxifen [10mg bd] × 1yr
2 Diethylstilboestrol × 6m

8712 85J5 CMF Versus A Versus CMF and Tamoxifen Trial: Stage IIIa; T3 N0; Operable; Modified Halsted Mastectomy; Premenopausal; Entry MAR-1985 to OCT-1989 (106 patients were entered)

1 Radiotherapy preoperative then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4 then (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil) × 2
2 Radiotherapy preoperative then Doxorubicin [50mg/m² iv d1,8] q4wk × 5
3 Radiotherapy preoperative then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4 then (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil) × 2 + Tamoxifen [10mg bd] × 1yr

8713 85J6 Tamoxifen Versus Synestrol Trial: Stage IIIa; Operable; T3 N0; Postmenopausal; Modified Halsted Mastectomy; Age 51+; Entry MAR-1985 to DEC-1989 (66 patients were entered)

1 Tamoxifen [10mg bd] × 1yr
2 Synestrol × 6m

8714 85J7 Tamoxifen Trial: Premenopausal; Entry JAN-1985 to 1985 (7 patients were entered; stopped early; not received)

1 Oöphorectomy + P + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4 then (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil) × 2
2 Oöphorectomy + P + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4 then (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil) × 2 + Tamoxifen [10mg bd] × 1yr

8715 86Q Ciba-Geigy Trial: Stage IIb-IIIb; Postmenopausal; T1-2 N1-2 M0; Entry MAR-1986 to DEC-1987 (47 patients were entered)

1 Aminoglutethimide [250mg bd] + Cortisone
2 Tamoxifen [10mg bd] × 1yr

8716 85J8 CMF/A/CMFTam Trial: Stage IIIb; Operable; Modified Halsted Mastectomy; Premenopausal; Entry JAN-1985 to DEC-1990 (403 patients were entered)

1 Radiotherapy preoperative then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4 then (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil) × 2
2 Radiotherapy preoperative then Doxorubicin/Carminomycin
3 Radiotherapy preoperative then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4 then (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil) × 2 + Tamoxifen [10mg bd] × 1yr

8717 Surgery and Radiotherapy Trial: Stage I-IIa; Entry JAN-1985 to DEC-1989 (164 patients were entered; nonstandard randomisation)

1 Sectoral Resection + Axillary Dissection + Radiotherapy
2 Patey Mastectomy

8718 85J9 Tamoxifen Versus Diethylstilboestrol Trial: Stage IIIb; Operable; (T2 N2)/(T3 N1+); Postmenopausal; Modified Halsted Mastectomy; Age 51+; Entry JAN-1985 to SEP-1989 (69 patients were entered)

1 Tamoxifen [10mg bd] × 1yr
2 Diethylstilboestrol × 6m

8719 83K Surgery and Radiotherapy Trial: Stage IIa-IIb; Entry 1983 to 1985 (stopped early; not received)

1 Modified Halsted Mastectomy + Radiotherapy [parasternal]
2 Urban Mastectomy

8720 85V Phase III Trial (Topuzov): Stage IIb-IIIa; Mastectomy with Complete Axillary Clearance; Age 27-55; Entry 1985 to 1990 (271 patients were entered; not received)

1 Radiotherapy preoperative + (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil) × 2 preoperative then (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil) × 4-6 postoperative
2 Radiotherapy preoperative then (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil) × 4-6 postoperative

89 Osaka Center for Adult Diseases, Japan {Koyama, Morimoto, Nakao, Sakai, Senoo, Taguchi, Terasawa: SEP-1990 (REVISED VERSION)}

8901 61G1 First Study (4-Way): Entry AUG-1961 to DEC-1978 (684 patients were entered; includes 8904 pro temp.; nonstandard randomisation)

1 Mitomycin-C perioperative
2 Cyclophosphamide × 6m
3 Control
4 Mitomycin-C perioperative + Cyclophosphamide × 6m

8902 Ftorafur Trial: randomisation deliberately chosen to be 1:1·2; Entry 1978 to 1982 (590 patients were entered; 1985 overview synthetic data only; no recurrence information; nonstandard randomisation)

1 Control
2 Ftorafur × 1yr

8903 79S Second Study: Entry OCT-1979 to MAR-1985 (335 patients were entered) {imbalance ascribed by Koyama to play of chance}

1 Mitomycin-C perioperative + (Cyclophosphamide + Ftorafur) × 1yr + Tamoxifen [20mg/d] × 1yr
2 Mitomycin-C perioperative + Cyclophosphamide × 1yr

8904 61G2 First Study (2-Way): Entry 1962 to 1978 (removed to 8901 pro temp; nonstandard randomisation)

1 Mitomycin-C perioperative + Cyclophosphamide × 6m
2 Control

8905 96P CUBC Study (Koyama): N+; Entry JUL-1996 to JUN-2000 (about 400 patients were entered; not received)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Tamoxifen
2 Uracil + Ftorafur + Tamoxifen

8906 91N Preoperative Tamoxifen Trial: ER+; PR+; Entry 1991 (20 patients were entered; not received)

1 Tamoxifen × 6-10d preoperative
2 Control

90 Herzen Oncology Institute, Moscow, Russia {Demidov: JUL-1989}

9001 __A1 Chemotherapy and Radiotherapy Trial: Stage II; N1; Halsted Mastectomy; Entry ? (506 patients were entered; nonstandard randomisation; not received)

1 (Triethylenephosphoramide/Cyclophosphamide + 5-Fluoro-Uracil) × 5 over 2yr
2 Control
3 Radiotherapy postoperative

9002 __A2 CMF Trial: Stage II; Entry ? (nonstandard randomisation; not received)

1 Control
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

9003 __A3 CMF Trial: Stage III; Entry ? (nonstandard randomisation; not received)

1 Control
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

91 Ghent University Hospital, Belgium {Mareel, De Schryver, Vakaet: AUG-2000 (REVISED VERSION, UPDATED)}

9101 78Y1 Nolvadex Study (excluding only Holy Family Hospital patients): N-; Age < 75; Postmenopausal; Entry OCT-1978 to JAN-1985 (138 patients were entered)

1 Control
2 Tamoxifen [20mg/d] × 2yr

9102 78Y2 CMFV Versus Nolvadex: N+; Entry NOV-1978 to DEC-1984 (149 patients were entered)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + V
2 Tamoxifen [20mg/d] × 2yr

93 Wessex Radiotherapy Centre, U.K. {Buchanan, Cross, Gardner, Royle, Williams: NOV-2000 (UPDATED EIGHT TIMES)}

9301 73A Mastectomy Patients: ER?; Entry MAR-1973 to JUL-1975 (151 patients were entered)

1 Radiotherapy [megavoltage] × 4·5wk postoperative
2 Control

9302 80Z1 Wessex Adjuvant Chemotherapy Trial: T1-2 N0 M0; ER-; Entry DEC-1980 to MAR-1986 (52 patients were entered)

1 Control
2 (Doxorubicin + Vincristine + P/Cyclophosphamide) × 6

9303 80Z2 Wessex Adjuvant Chemotherapy Trial: N+; ER-; Entry FEB-1981 to JAN-1983 (18 patients were entered)

1 Control
2 (Doxorubicin + Vincristine + P/Cyclophosphamide) × 6

9304 80Z3 Wessex Adjuvant Chemotherapy Trial: N+; ER+; Entry MAR-1981 to JAN-1983 (23 patients were entered)

1 Tamoxifen × 6m/12m
2 (Doxorubicin + Vincristine + P/Cyclophosphamide) × 6 + Tamoxifen × 6m/12m

94 Memorial Sloan-Kettering Cancer Center, U.S.A. {Hakes, Hudis, Norton, Wittes: MAY-2001 (SECOND REVISED VERSION, UPDATED)}

9401 76S M.S.K.C.C. (Hakes and Wittes): N+; Entry MAR-1976 to APR-1980 (256 patients were entered)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Levamisole

9402 M.S.K.C.C. (Hakes and Wittes): N-; Entry ? (never activated; not received)

1 Chlorambucil + Methotrexate + 5-Fluoro-Uracil
2 Chlorambucil + Methotrexate + 5-Fluoro-Uracil + Levamisole

9403 80T CMFVP(T) (Hakes and Wittes): N+; Entry MAY-1980 to NOV-1985 (324 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + P) [low dose] + Tamoxifen
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + P) [high dose] + Tamoxifen

9404 80V1 Chemohormonotherapy Trial: Locally Advanced; N+; ER-; Entry MAY-1980 to JUN-1984 (28 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + Prednisone) × 12m
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6m then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + Prednisone) × 6m

9405 80V2 Chemohormonotherapy Trial: Locally Advanced; N+; ER+; Entry AUG-1980 to DEC-1983 (13 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + Prednisone) × 12m + Tamoxifen [20mg bd] × 1yr
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6m then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine + Prednisone) × 6m + Tamoxifen [20mg bd] × 1yr

9407 Axillary Lymphadenectomy Arm Mobilisation Trial: Drainage Endpoint; Entry ? (57 patients were entered; not received)

1 Early mobilisation
2 Late mobilisation

9408 (Hudis): Entry post-1990 (never activated)

1 Doxorubicin then Cyclophosphamide
2 Doxorubicin then Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

9409 94E MSKCC 9485: Entry AUG-1994 to MAY-1995 (44 patients were entered)

1 Doxorubicin then Paclitaxel then Cyclophosphamide (sequential)
2 Doxorubicin then Paclitaxel + Cyclophosphamide (concurrent)

96 Piedmont Oncology Association, U.S.A. {Cooper, Jackson: AUG-1990 (UPDATED THRICE)}

9601 74Q P.O.A. Protocol No. 74176, Adjuvant Chemotherapy for Post-Operative Carcinoma of the Breast with Lymph Node Metastases - Phase III (Cooper): Axillary Clearance; N+; Entry DEC-1974 to DEC-1979 (280 patients were entered)

1 Melphalan × 2yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 2yr
3 Radiotherapy [megavoltage] + Melphalan × 2yr
4 Radiotherapy [megavoltage] + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 2yr

9602 83G Neurotoxicity Study (Jackson): Stage II; N+; Entry JUL-1983 to DEC-1985 (87 patients were entered; synthetic data; no event information)

1 Vincristine
2 Vincristine + Glutamic Acid

97 Bordeaux Institut Bergonié, France {Bonichon, Durand, Mauriac: OCT-2000 (REVISED VERSION, UPDATED TWICE)}

9701 81B Essai Randomisé d'Hormonotherapie Adjuvante: ER+/PR+; N+; Entry MAY-1981 to JAN-1985 (326 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m + Tamoxifen [30mg/d] × 2yr

9703 85M1 Patey Mastectomy and Adjuvant Chemotherapy Versus Preoperative Chemotherapy and Adjusted Locoregional Treatment: Entry JAN-1985 to APR-1989 (272 patients were entered)

1 Mastectomy (+ adjuvant (4-Epi-Doxorubicin + Vincristine + Methotrexate) × 3 + (Mitomycin-C + Triethylenephosphoramide + Vindesine) × 3 for N+ and/or ER-/PR-)
2 Induction (4-Epi-Doxorubicin + Vincristine + Methotrexate) × 3 + (Mitomycin-C + Triethylenephosphoramide + Vindesine) × 3 + ((Radiotherapy for absence of residual tumour) or (Radiotherapy + Tumorectomy for < 2cm residual tumour) or (Patey Mastectomy for > 2cm residual tumour))

9704 79M Immunotherapy: Age 51+; N4+; second randomisation from chemotherapy after remission; Entry JAN-1979 to NOV-1981 (62 patients were entered; synthetic data only; no death information; real data unavailable)

1 Control
2 Levamisole × 1yr
3 Bacillus Calmette-Guèrin × 1yr

9705 85M2 Adjuvant Chemotherapy: N+/(ER-, PR-); Entry JAN-1985 to MAY-1993 (390 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 9
2 (Methotrexate + Triethylenephosphoramide + Vindesine) × 3 + (Methotrexate + 4-Epi-Doxorubicin + Vincristine) × 3

9706 81Q F.B.B.G.S. Levamisole: Entry MAY-1981 to JAN-1985 (355 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m + Levamisole × 1yr

99 ACETBC, Japan {O. Abe, R. Abe, Enomoto, Hattori, Koyama, Masuda, Miura, Nomura, Sakai, Sakashita, Sawa, Sugimachi, Uchino, Yoshida: DEC-1995 (SECOND REVISED VERSION, UPDATED)}

9901 82$ ACETBC Pilot, Kanto (Prof. O. Abe and Dr K. Enomoto, Tokyo): Stage II-III; Entry ? (228 patients were entered; not received)

1 Ftorafur
2 Ftorafur + Tamoxifen [20mg/d] × 2yr

9902 82L1 ACETBC-1, Kanto (Prof. O. Abe and Dr K. Enomoto, Tokyo): Stage II-IIIa; Entry JUN-1982 to DEC-1984 (1725 patients were entered)

1 Mitomycin-C perioperative + Ftorafur × 2yr
2 Mitomycin-C perioperative + (Ftorafur + Tamoxifen [20mg/d]) × 2yr

9903 82L2 ACETBC-1, Hokkaido (Prof. J. Uchino, Sapporo): Stage II-IIIa; Entry SEP-1982 to FEB-1985 (546 patients were entered)

1 Doxorubicin + Ftorafur
2 Doxorubicin + Ftorafur + Tamoxifen [20mg/d] × 2yr

9904 82L3 ACETBC-1, Tohoku (Dr K. Kikuchi, Sendai and Prof. R. Abe, Fukushima): Stage II-IIIa; Entry OCT-1982 to JAN-1985 (619 patients were entered)

1 Mitomycin-C + Ftorafur × 1yr
2 Mitomycin-C + (Ftorafur + Tamoxifen [20mg/d]) × 1yr

9905 82L4 ACETBC-1, Chubu (Dr M. Yoshida, Central Japan Group, Nagoya): Stage II-III; Entry OCT-1982 to MAR-1985 (866 patients were entered)

1 Mitomycin-C + Ftorafur × 2yr
2 Mitomycin-C + (Tamoxifen [20mg/d] + Ftorafur) × 2yr
3 Mitomycin-C + Tamoxifen [20mg/d] × 2yr

9906 82L5 ACETBC-1, Kinki (Dr H. Koyama, Osaka and Dr K. Sakai, Tanabe): T1a-3a N0-1b; Entry MAR-1982 to FEB-1985 (1254 patients were entered)

1 Ftorafur
2 Ftorafur + Tamoxifen [20mg/d] × 1yr

9907 82L6 ACETBC-1, Nishinihon (Dr Y. Nomura and Prof. K. Sugimachi, Fukuoka): ER+; Stage II-IIIa; Entry JAN-1982 to FEB-1985 (587 patients were entered)

1 Mitomycin-C + Ftorafur
2 Mitomycin-C + Ftorafur + Tamoxifen [20mg/d] × 2yr

9908 82L7 ACETBC-1, Nishinihon (Dr Y. Nomura and Prof. K. Sugimachi, Fukuoka): ER-; Stage II-IIIa; Entry SEP-1982 to FEB-1985 (380 patients were entered)

1 Mitomycin-C + Ftorafur
2 Mitomycin-C + Ftorafur + Basidiomycetes Protein Polysaccharide

9909 85H1 ACETBC-2, Kanto (Prof. O. Abe and Dr K. Enomoto, Tokyo): ER+; Stage II; Entry JAN-1985 to APR-1988 (1427 patients were entered)

1 Mitomycin-C perioperative + Tamoxifen [30mg/d] × 2yr
2 Mitomycin-C perioperative + (Tamoxifen [30mg/d] + Ftorafur) × 2yr

9910 85H2 ACETBC-2, Kanto (Prof. O. Abe and Dr K. Enomoto, Tokyo): ER-; Stage II; Entry JAN-1985 to JUL-1988 (796 patients were entered)

1 Mitomycin-C perioperative + Ftorafur × 2yr
2 Mitomycin-C perioperative + Ftorafur × 2yr + Cyclophosphamide × 1yr

9911 85H3 ACETBC-2, Hokkaido (Prof. J. Uchino, Sapporo): ER+; Stage II; Entry FEB-1985 to OCT-1988 (392 patients were entered)

1 Mitomycin-C perioperative + Tamoxifen [30mg/d] × 2yr
2 Mitomycin-C perioperative + (Tamoxifen [30mg/d] + Ftorafur) × 2yr

9912 85H4 ACETBC-2, Hokkaido (Prof. J. Uchino, Sapporo): ER-; Stage II; Entry FEB-1985 to OCT-1988 (283 patients were entered)

1 Mitomycin-C perioperative + Ftorafur × 2yr
2 Mitomycin-C perioperative + (Ftorafur + Basidiomycetes Protein Polysaccharide) × 2yr

9913 85H5 ACETBC-2, Tohoku (Dr K. Kikuchi, Sendai and Prof. R. Abe, Fukushima): ER+; Stage II; Entry FEB-1985 to APR-1988 (404 patients were entered)

1 Mitomycin-C perioperative + Tamoxifen [30mg/d] × 2yr
2 Mitomycin-C perioperative + (Tamoxifen [30mg/d] + Ftorafur) × 2yr

9914 85H6 ACETBC-2, Tohoku (Dr K. Kikuchi, Sendai and Prof. R. Abe, Fukushima): ER-; Stage II; Entry JAN-1985 to MAR-1988 (222 patients were entered)

1 Mitomycin-C perioperative + Ftorafur × 2yr
2 Mitomycin-C perioperative + (Uracil + Ftorafur) × 2yr

9915 85H7 ACETBC-2, Chubu (Dr S. Miura and Dr M. Yoshida, Central Japan Group, Nagoya): ER+; Stage II; Entry FEB-1985 to JUN-1988 (542 patients were entered)

1 Mitomycin-C perioperative + Tamoxifen [30mg/d] × 2yr
2 Mitomycin-C perioperative + (Tamoxifen [30mg/d] + Ftorafur) × 2yr

9916 85H8 ACETBC-2, Chubu (Dr S. Miura and Dr M. Yoshida, Central Japan Group, Nagoya): ER-; Stage II; Entry MAR-1985 to FEB-1988 (396 patients were entered)

1 Mitomycin-C perioperative + Ftorafur × 2yr
2 Mitomycin-C perioperative + (Ftorafur + Tamoxifen [30mg/d]) × 2yr

9917 85H9 ACETBC-2, Kinki (Dr H. Koyama, Osaka and Dr K. Sakai, Tanabe): ER+; Stage II; Entry JAN-1985 to MAR-1988 (536 patients were entered)

1 (Tamoxifen [20mg/d] + Ftorafur) × 1yr
2 (Tamoxifen [20mg/d] + Uracil + Ftorafur) × 1yr

9918 85Ha ACETBC-2, Kinki (Dr H. Koyama, Osaka and Dr K. Sakai, Tanabe): ER-; Stage II; Entry JAN-1985 to SEP-1988 (329 patients were entered)

1 (Cyclophosphamide + Ftorafur) × 1yr
2 (Cyclophosphamide + Uracil + Ftorafur) × 1yr

9919 85Hb ACETBC-2, Nishinihon (Dr Y. Nomura and Prof. K. Sugimachi, Fukuoka): ER+; Stage II; Entry JAN-1985 to MAR-1988 (540 patients were entered)

1 Mitomycin-C perioperative + Tamoxifen [30mg/d] × 2yr
2 Mitomycin-C perioperative + (Tamoxifen [30mg/d] + Ftorafur) × 2yr
3 Mitomycin-C perioperative + (Tamoxifen [30mg/d] + Basidiomycetes Protein Polysaccharide) × 2yr

9920 85Hc ACETBC-2, Nishinihon (Dr Y. Nomura and Prof. K. Sugimachi, Fukuoka): ER-; Stage II; Entry FEB-1985 to MAR-1988 (376 patients were entered)

1 Mitomycin-C perioperative + Ftorafur × 2yr
2 Mitomycin-C perioperative + Basidiomycetes Protein Polysaccharide × 2yr

9921 85Hd ACETBC-2, Kanto (Prof. O. Abe and Dr K. Enomoto, Tokyo): ER+; Stage IIIa; Entry JAN-1985 to FEB-1988 (172 patients were entered)

1 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + Ftorafur × 2yr
2 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + (Ftorafur + Tamoxifen [30mg/d]) × 2yr

9922 85He ACETBC-2, Kanto (Prof. O. Abe and Dr K. Enomoto, Tokyo): ER-; Stage IIIa; Entry JAN-1985 to FEB-1988 (165 patients were entered)

1 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + Ftorafur × 2yr
2 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + Ftorafur × 2yr + Doxorubicin × 1yr

9923 85Hf ACETBC-2, Hokkaido (Prof. J. Uchino, Sapporo): ER+; Stage IIIa; Entry MAR-1985 to AUG-1988 (61 patients were entered)

1 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + Ftorafur × 2yr
2 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + (Ftorafur + Tamoxifen [30mg/d]) × 2yr

9924 85Hg ACETBC-2, Hokkaido (Prof. J. Uchino, Sapporo): ER-; Stage IIIa; Entry FEB-1985 to AUG-1988 (67 patients were entered)

1 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + Ftorafur × 2yr
2 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + Ftorafur × 2yr + Doxorubicin × 1yr

9925 85Hh ACETBC-2, Tohoku (Dr K. Kikuchi, Sendai and Prof. R. Abe, Fukushima): ER+; Stage IIIa; Entry FEB-1985 to MAR-1988 (44 patients were entered)

1 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + Ftorafur × 2yr
2 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + (Ftorafur + Tamoxifen [30mg/d]) × 2yr

9926 85Hj ACETBC-2, Tohoku (Dr K. Kikuchi, Sendai and Prof. R. Abe, Fukushima): ER-; Stage IIIa; Entry FEB-1985 to MAR-1988 (49 patients were entered)

1 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + Ftorafur × 2yr
2 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + Ftorafur × 2yr + Doxorubicin × 1yr

9927 85Hk ACETBC-2, Chubu (Dr S. Miura and Dr M. Yoshida, Central Japan Group, Nagoya): ER+; Stage IIIa; Entry MAR-1985 to FEB-1988 (79 patients were entered)

1 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + Ftorafur × 2yr
2 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + (Ftorafur + Tamoxifen [30mg/d]) × 2yr

9928 85Hm ACETBC-2, Chubu (Dr S. Miura and Dr M. Yoshida, Central Japan Group, Nagoya): ER-; Stage IIIa; Entry MAR-1985 to FEB-1988 (74 patients were entered)

1 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + Ftorafur × 2yr
2 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + Ftorafur × 2yr + Doxorubicin × 1yr

9929 85Hn ACETBC-2, Kinki (Dr H. Koyama, Osaka and Dr K. Sakai, Tanabe): ER+; Stage IIIa; Entry FEB-1985 to FEB-1988 (77 patients were entered)

1 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + Ftorafur × 2yr
2 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + (Ftorafur + Tamoxifen [30mg/d]) × 2yr

9930 85Hp ACETBC-2, Kinki (Dr H. Koyama, Osaka and Dr K. Sakai, Tanabe): ER-; Stage IIIa; Entry JAN-1985 to MAR-1988 (62 patients were entered)

1 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + Ftorafur × 2yr
2 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + Ftorafur × 2yr + Doxorubicin × 1yr

9931 85Hq ACETBC-2, Nishinihon (Dr Y. Nomura and Prof. K. Sugimachi, Fukuoka): ER+; Stage IIIa; Entry FEB-1985 to NOV-1987 (76 patients were entered)

1 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + Ftorafur × 2yr
2 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + (Ftorafur + Tamoxifen [30mg/d]) × 2yr

9932 85Hr ACETBC-2, Nishinihon (Dr Y. Nomura and Prof. K. Sugimachi, Fukuoka): ER-; Stage IIIa; Entry FEB-1985 to JAN-1988 (97 patients were entered)

1 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + Ftorafur × 2yr
2 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 + Ftorafur × 2yr + Doxorubicin × 1yr

103 Gunma University School of Medicine, Maebashi, Japan {Izuo, Morishita, Takei, Yokoe: JAN-2001 (UPDATED FIVE TIMES)}

10301 80K Adjuvant Chemotherapy with Immunotherapy, Gunma University: Entry JUN-1980 to MAY-1984 (55 patients were entered)

1 Cyclophosphamide + 5-Fluoro-Uracil + Mitomycin-C + Prednisone + Levamisole
2 Cyclophosphamide + 5-Fluoro-Uracil + Mitomycin-C + Prednisone + Basidiomycetes Protein Polysaccharide

10302 Surgery Trial: Stage I-II; Entry 1991 ff. (200 patients were entered; nonstandard randomisation; not received)

1 Modified Radical Mastectomy + Tamoxifen + (5-Fluoro-Uracil/Cyclophosphamide + Uracil + Ftorafur)
2 Breast Conserving Surgery + Tamoxifen + (5-Fluoro-Uracil/Cyclophosphamide + Uracil + Ftorafur)

10303 97B Gunma-Niigata-Saitama Surgical Adjuvant Study Group of Breast Cancer: Postmenopausal; Age 50+; Stage I-IIIa; ER+; Entry DEC-1997 ff. (not received)

1 Toremifene [40mg/d] × 3yr
2 Tamoxifen [20mg/d] × 3yr

104 University of Arizona, U.S.A. {Jones: 24-MAY-1984}

10401 Protocol UARIZ-674; UARIZ-IVB: Entry 1975 ff. (not randomised; not received)

1 Doxorubicin + Cyclophosphamide + Radiotherapy
2 Doxorubicin + Cyclophosphamide

105 Aichi Cancer Center Hospital, Nagoya, Japan {Miura, Yoshida: 1986}

10501 The Nagoya Cyclophosphamide Trial: Entry ? (350 patients were entered; not randomised; not received)

1 Control
2 Cyclophosphamide

106 Leicester, U.K. {Madden: JAN-1995}

10601 CFV/CMV Trial: Premenopausal; N+; Entry ? (never activated; not received)

1 (Cyclophosphamide + 5-Fluoro-Uracil + Vincristine then Cyclophosphamide + Methotrexate + Vincristine) × 3
2 Control

10602 90G1 Multicentre Study: Invasive Carcinoma; Age < 51; N1-9; Level 2 Axillary Dissection; Entry APR-1990 to 1996 (104 patients were entered into 10602+10603; not received)

1 Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) q4wk × 6
2 Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) q4wk × 3

10603 90G2 Multicentre Study: Invasive Carcinoma; Age < 51; N-; Entry APR-1990 to 1996 (104 patients were entered into 10602+10603; not received)

1 Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) q4wk × 6
2 Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) q4wk × 3

107 Children's Cancer Research Foundation and Harvard Medical School, U.S.A. {Henderson, Nevinny: 1969}

10701 61A Prophylactic Oöphorectomy: Entry 1961 ff. (179 patients were entered; synthetic data only, 36 'ineligibles' missing; a special follow-up is to be undertaken to get the patient information)

1 Control
2 Oöphorectomy

108 University of Lund, Malmö, Sweden {Landberg, Tengrup, Tennvall: OCT-2000 (UPDATED FOUR TIMES)}

10801 Prophylactic Oöphorectomy: Entry JAN-1961 to JUL-1985 (321 patients were entered; approximate dates; nonstandard randomisation)

1 Control
2 Oöphorectomy
3 Unknown

112 Osaka City Medical School, Japan {Morimoto, Sakai: JUN-2000 (UPDATED TWICE)}

11201 69B S44-48: Entry JAN-1969 to AUG-1973 (51 patients were entered; 1 patient missing)

1 Cyclophosphamide × 5yr
2 5-Fluoro-Uracil × 3d
3 Control

11202 S49-51: Entry MAR-1973 to DEC-1977 (102 patients were entered; allocation by surgery date)

1 F × 5yr
2 Cyclophosphamide × 5yr

11203 77M CQ Trial: Entry AUG-1977 to OCT-1982 (150 patients were entered)

1 Control
2 Carbazil Quinone × 5yr
3 (Carbazil Quinone + Basidiomycetes Protein Polysaccharide) × 5yr

11204 82M Tamoxifen and Levamisole Trial: Entry MAR-1982 to SEP-1986 (151 patients were entered)

1 Cyclophosphamide × 5yr
2 Cyclophosphamide × 5yr + Tamoxifen [20mg/d] × 5yr
3 Cyclophosphamide × 5yr + Levamisole

11205 88L Radical Mastectomy Trial: Entry 1988 ff. (not received)

1 Patey Mastectomy
2 Halsted Mastectomy

11206 88M Tamoxifen Trial: T1a N0; Entry 1988 ff. (not received)

1 Tamoxifen
2 Control

11207 88N HCFU Trial: Entry 1988 ff. (not received)

1 Carbazil Quinone
2 HCFU
3 HCFU + Basidiomycetes Protein Polysaccharide

113 Tokyo Cancer Institute Hospital, Japan {Kasumi, Nishi, Watanabe, Yoshimoto: JUN-2000 (REVISED VERSION)}

11301 89K Tamoxifen Trial: Entry 1989 ff. (220 patients were entered; not received)

1 Control
2 Tamoxifen [20mg/d] × 2/5yr

11302 Mitomycin-C Trial: Original Protocol; Entry JAN-1968 ff. (452 patients were entered into 11302+11303; alternate allocations; all in 11302 pro temp.)

1 Control
2 Mitomycin-C [lower dose] perioperative

11303 Mitomycin-C Trial: Modified Protocol; Entry 1969 to DEC-1970 (452 patients were entered into 11302+11303; alternate allocations; in 11302 pro temp.)

1 Control
2 Mitomycin-C [higher dose] perioperative

11304 85Z PS Trial: Parasternal Lymph Node Metastases Proven by Open Biopsy; Entry SEP-1985 to SEP-1993 (150 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 Extended Dissection + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
3 Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6

11305 88U N2 Trial: Infraclavicular Lymph Node Metastases; Entry MAR-1988 to MAY-1994 (100 patients were entered)

1 Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12

11306 90X1 N0 Trial: Pathological High Risk; Entry JUL-1990 to FEB-1997 (287 patients were entered)

1 Control
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6

11307 90X2 MCMF Trial: N+; Premenopausal; Entry JUL-1990 to SEP-1996 (282 patients were entered; nonstandard randomisation)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 Mitomycin-C + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6

114 Breast Cancer HCFU Study Group, Japan {Dr T. Tominaga: JUN-2000 (UPDATED)}

11401 Tegafur Trial: Stage I-II; Entry FEB-1980 ff. (duplicates part of Kanto ACETBC; not received)

1 Mitomycin-C + Tamoxifen [20mg/d]
2 Mitomycin-C + Tamoxifen [20mg/d] + Ftorafur

11402 Adriamycin Trial: Stage III; Entry FEB-1980 ff. (nonexistent; not received)

1 Mitomycin-C + Tamoxifen [20mg/d] + Ftorafur
2 Mitomycin-C + Tamoxifen [20mg/d] + Ftorafur + Doxorubicin

11403 88X HCFU Trial: Axillary Clearance; N+; Entry DEC-1988 to NOV-1990 (789 patients were entered)

1 Cyclophosphamide [50mg/d po] + Tamoxifen [20mg/d po]
2 Cyclophosphamide [50mg/d po] + Tamoxifen [20mg/d po] + HCFU [300mg/d po]

115 Japan Clinical Oncology Group - Breast Cancer Study Group {Aogi, Takashima, Yasutomi: DEC-2000 (SECOND REVISED VERSION)}

11501 59A First Study: Age 30-59; Entry 1959 to 1960 (possibly not randomised; not received)

1 Mitomycin-C
2 Triethylenephosphoramide

11502 61C Second Study: Age 30-59; Entry 1961 to 1962 (possibly not randomised; not received)

1 Control
2 Triethylenephosphoramide

11503 63C Third Study: Age 30-59; Entry 1963 to 1965 (possibly not randomised; not received)

1 Control
2 Cyclophosphamide
3 Mitomycin-C

11504 66A Fourth Study: Age 30-59; Entry 1966 to 1968 (possibly not randomised; not received)

1 Radiotherapy
2 Radiotherapy + Cyclophosphamide
3 Radiotherapy + Mitomycin-C

11505 69C Fifth Study: Radical Mastectomy; Entry 1969 to 1971 (possibly not randomised; not received)

1 Radiotherapy
2 Radiotherapy + F
3 Radiotherapy + C + F + Mitomycin-C

11506 72E Sixth Study: Age 30-59; Mastectomy plus Lymph Node Dissection; Entry 1972 to 1974 (possibly not randomised; not received)

1 Control
2 F
3 C + F + Mitomycin-C

11507 75R Seventh Study: Age < 70; Entry 1975 to 1977 (possibly not randomised; not received)

1 Ftorafur
2 Cyclophosphamide

11508 78T Eighth Study: Age < 65; Stage II; Entry JUL-1978 to APR-1981 (316 patients were entered)

1 Cyclophosphamide [70mg/m²/d, total 25g/m² po] × 18m
2 Cyclophosphamide [70mg/m²/d, total 6g/m² po] × 6m

11509 81J Ninth Study: Age < 65; Stage II; Entry FEB-1981 to JUN-1984 (248 patients were entered)

1 Mitomycin-C [20mg iv] perioperative then Cyclophosphamide [70mg/m²/d to 7g/m² within 6m po]
2 Cyclophosphamide [70mg/m²/d to 25g/m² within 18m po]

11510 84F Tenth Study: Age < 65; Stage II; Entry JUN-1984 to AUG-1987 (224 patients were entered)

1 Mitomycin-C [20mg iv] perioperative then Cyclophosphamide [70mg/m²/d, total 12·6mg/m² po] × 12m
2 Mitomycin-C [20mg iv] perioperative then (Cyclophosphamide [70mg/m²/d, total 12·6mg/m² po] + (Uracil + Ftorafur) [280mg/m², total 50·4g/m² po]) × 12m

11511 86G1 Eleventh Study: Age < 65; Stage II; N-; Entry 1986 to 1989 (99 patients were entered; not received)

1 (Tamoxifen [20mg/d, total 14·6g po] + (Uracil + Ftorafur) [280mg/m²/d, total 86g/m² po]) × 2yr
2 (Tamoxifen [20mg/d, total 14·6g po] + Cyclophosphamide [70mg/m²/d, total 22g/m² po]) × 2yr

11512 86G2 Eleventh Study: Age < 65; Stage II; N+; Entry 1986 to 1989 (100 patients were entered; not received)

1 (Cyclophosphamide [50mg/d d1-14, total 7g po] + Doxorubicin [20mg d1, total 200mg iv] + 5-Fluoro-Uracil [200mg/d d1-14, total 28g po]) q28d × 10 + Tamoxifen [20mg/d] × 2yr
2 (Cyclophosphamide [50mg/d d1-14, total 7g po] + Methotrexate [40mg d1, total 400mg iv] + 5-Fluoro-Uracil [200mg/d d1-14, total 28g po]) q28d × 10 + Tamoxifen [20mg/d] × 2yr

11513 94F JCOG 9401: Postmenopausal; N+; Entry DEC-1994 to JUL-1999 (129 patients were entered)

1 Tamoxifen [20mg/d] × 2yr
2 (Doxorubicin [40mg/m²] + Cyclophosphamide [500mg/m²]) × 6 + Tamoxifen [20mg/d] × 2yr

11514 94G JCOG 9404: Premenopausal; N+; Entry DEC-1994 to JUN-1999 (169 patients were entered)

1 (Doxorubicin [40mg/m²] + Cyclophosphamide [500mg/m²]) × 6 + Tamoxifen [20mg/d] × 2yr
2 ((Uracil + Ftorafur) [400mg/d] + Tamoxifen [20mg/d]) × 2yr

11515 95E JCOG 9208: Curatively-Operated Patients; Phase III; Stage I-IIIB; Age 15-55; N11+; Entry 1995 to 1999 (97 patients were entered; not received)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6 then (Cyclophosphamide [high dose] + Triethylenephosphoramide) × 3d + Peripheral Stem Cell Transplantation

119 Kumamoto University Group, Japan {Akagi, Misumi, Ogawa, Yamashita: JAN-1990}

11901 82N1 Stage I: Entry NOV-1982 to AUG-1986 (131 patients were entered)

1 Mitomycin-C perioperative
2 Mitomycin-C perioperative + Tamoxifen [20mg/d] × 2yr

11902 82N2 Stage II, IIIa: Entry DEC-1982 to SEP-1985 (53 patients were entered)

1 Mitomycin-C perioperative + 5-Fluoro-Uracil × 2yr
2 Mitomycin-C perioperative + (5-Fluoro-Uracil + Tamoxifen [20mg/d]) × 2yr

120 Tokushima University, Japan {Monden, Morimoto: 1985}

12001 82P1 Stage I, II, IIIa: N0; Entry OCT-1982 to SEP-1985 (not received)

1 Mitomycin-C perioperative + Tamoxifen [20mg/d] × 3yr
2 Mitomycin-C perioperative + (Tamoxifen [20mg/d] + Ftorafur intermittent) × 3yr

12002 82P2 Stage I, II, IIIa: N1-2; Entry OCT-1982 to SEP-1985 (not received)

1 Mitomycin-C perioperative + (Tamoxifen [20mg/d] + Ftorafur intermittent) × 3yr
2 Mitomycin-C perioperative + (Tamoxifen [20mg/d] + Ftorafur intermittent + Mitomycin-C intermittent) × 3yr

121 Oita Prefectural Hospital, Japan {Nakamura, Ueo: OCT-1996 (UPDATED TWICE)}

12101 83F1 Stage I: Entry MAY-1983 to JUN-1987 (197 patients were entered)

1 Cyclophosphamide [5mg/kg/d iv d0-5]
2 Cyclophosphamide [5mg/kg/d iv d0-5] + Cyclophosphamide [100mg/d po] × 1yr
3 Cyclophosphamide [5mg/kg/d iv d0-5] + Cyclophosphamide [100mg/d po] × 1yr + Tamoxifen [20mg/d po] × 2yr
4 Cyclophosphamide [5mg/kg/d iv d0-5] + (Cyclophosphamide [100mg/d po] + Prednisolone [5mg/d po]) × 1yr + Tamoxifen [20mg/d po] × 2yr

12102 83F2 Stage II: Entry APR-1983 to APR-1987 (50 patients were entered)

1 Cyclophosphamide [5mg/kg/d iv d0-5]
2 Cyclophosphamide [5mg/kg/d iv d0-5] + Cyclophosphamide [100mg/d po] × 1yr
3 Cyclophosphamide [5mg/kg/d iv d0-5] + Cyclophosphamide [100mg/d po] × 1yr + Tamoxifen [20mg/d po] × 2yr
4 Cyclophosphamide [5mg/kg/d iv d0-5] + (Cyclophosphamide [100mg/d po] + Prednisolone [5mg/d po]) × 1yr + Tamoxifen [20mg/d po] × 2yr

12103 83F3 Stage III: Entry APR-1983 to AUG-1989 (88 patients were entered)

1 Cyclophosphamide [5mg/kg/d iv d0-5] + Cyclophosphamide [100mg/d po] × 1yr + Tamoxifen [20mg/d po] × 2yr
2 Cyclophosphamide [5mg/kg/d iv d0-5] + (Cyclophosphamide [100mg/d po] + Prednisolone [5mg/d po]) × 1yr + Tamoxifen [20mg/d po] × 2yr

12104 87E1 Stage I and II: N-; Entry JUN-1987 to DEC-1994 (274 patients were entered)

1 Cyclophosphamide perioperative
2 Cyclophosphamide perioperative + Tamoxifen [20mg/d] × 2yr

12105 87E2 Stage I and II: N+; Entry MAY-1989 to JUL-1996 (110 patients were entered)

1 Cyclophosphamide perioperative + (Ftorafur + Prednisolone) × 1yr + Tamoxifen [20mg/d] × 2yr
2 Cyclophosphamide perioperative + (Ftorafur + Prednisolone) × 1yr + Tamoxifen [20mg/d] × 3yr

123 Copenhagen Radium Centre, Denmark {Johansen, Kaae: MAR-2000 (REVISED VERSION, UPDATED TEN TIMES)}

12301 51A Copenhagen Radiotherapy Trial: Entry NOV-1951 to DEC-1957 (666 patients were entered)

1 Simple Mastectomy + Radiotherapy
2 Extended Radical Mastectomy

126 Glasgow Institute of Radiotherapeutics and Oncology, Scotland {Yosef: DEC-2000 (UPDATED TWICE)}

12601 76N Adjuvant Chemotherapy of Operable Breast Carcinoma with Pathologically Involved Lymph Nodes: N+; Entry DEC-1976 to APR-1988 (45 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr
2 Melphalan × 9m

127 Amsterdam Integraal Kankercentrum, Netherlands {Borger, Bruning, van Dongen, Lebesque, Peterse, van de Velde, Vermorken: JUN-2000 (SECOND REVISED VERSION)}

12701 82R1 Adjuvant Tamoxifen C8209: Postmenopausal; Stage I-III; N-/N+; 1:2 Randomisation; Entry JUL-1982 to MAR-1988 (675 patients were entered)

1 Control
2 Tamoxifen [10mg tds] × 1yr

12702 82R2 Adjuvant Tamoxifen C8209: Postmenopausal; Stage I-III; second randomisation of treated N-/N+ patients at 1 year; Entry JUL-1983 to APR-1989 (342 patients were entered)

1 Tamoxifen [10mg tds] × 1yr
2 Tamoxifen [10mg tds] × 3yr

12703 82R3 Adjuvant Tamoxifen C8209: Postmenopausal; Stage I-III; N-; 1:2 Randomisation; Entry APR-1988 to FEB-1994 (586 patients were entered)

1 Control
2 Tamoxifen [10mg tds] × 1yr

12704 82R4 Adjuvant Tamoxifen C8209: Postmenopausal; Stage I-III; N+/(second randomisation of treated N- patients at 1 year); Entry MAR-1989 to JUN-1995 (649 patients were entered)

1 Tamoxifen [10mg tds] × 1yr
2 Tamoxifen [10mg tds] × 3yr

12705 90P CMF Versus Observation C8913: Morphometrically Unfavourable Breast Cancer (PREMIS); N-; Premenopausal; Entry DEC-1990 to MAY-1998 (271 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 Control

12706 92D Chemotherapy With EC C9203: N+; Postmenopausal; Entry OCT-1992 to OCT-1997 (102 patients were entered)

1 (4-Epi-Doxorubicin [iv] + Cyclophosphamide) × 4 + Tamoxifen [30mg/d] × 3yr
2 Tamoxifen [30mg/d] × 3yr

12707 90Q (Borger, van Dongen and Lebesque): Postmenopausal; N0; Entry FEB-1990 to JUL-1992 (18 patients were entered; not received)

1 Axillary Clearance
2 Radiotherapy [to axilla]

129 Tianjin Cancer Institute, China {Fang, Lang: JAN-1989}

12901 87F1 Randomised Clinical Trial of Adjuvant Therapy in Primary Breast Cancer A: Stage I-III; Premenopausal; ER+; N4+; Entry JUN-1987 to DEC-1989 (nonstandard randomisation; not received)

1 Oöphorectomy + Colchicine + Uraphetine + Tamoxifen [20mg/d] indefinitely
2 Oöphorectomy + Tamoxifen [20mg/d] indefinitely

12902 87F2 Randomised Clinical Trial of Adjuvant Therapy in Primary Breast Cancer A: Stage I-III; Premenopausal; ER+; N1-3; Entry JUN-1987 to DEC-1989 (nonstandard randomisation; not received)

1 Colchicine + Uraphetine + Tamoxifen [20mg/d] indefinitely
2 Tamoxifen [20mg/d] indefinitely

12903 87F3 Randomised Clinical Trial of Adjuvant Therapy in Primary Breast Cancer A: Stage I-III; Postmenopausal; ER+; N+; Entry JUN-1987 to DEC-1989 (nonstandard randomisation; not received)

1 Colchicine + Uraphetine + Tamoxifen [20mg/d] indefinitely
2 Tamoxifen [20mg/d] indefinitely

12904 87F4 Randomised Clinical Trial of Adjuvant Therapy in Primary Breast Cancer B: Stage I-III; ER-; N+; Entry JUN-1987 to DEC-1989 (nonstandard randomisation; not received)

1 Colchicine + Uraphetine
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

12905 87F5 Randomised Clinical Trial of Adjuvant Therapy in Primary Breast Cancer C: Stage I-II; ER+; N-; Entry JUN-1987 to DEC-1989 (nonstandard randomisation; not received)

1 Tamoxifen [20mg/d] indefinitely
2 Control

12906 87F6 Randomised Clinical Trial of Adjuvant Therapy in Primary Breast Cancer E: T3 Nonspecific; ER+; N-; Entry JUN-1987 to DEC-1989 (nonstandard randomisation; not received)

1 Oöphorectomy + Colchicine + Uraphetine + Tamoxifen [20mg/d] indefinitely
2 Oöphorectomy + Tamoxifen [20mg/d] indefinitely

12907 87F7 Randomised Clinical Trial of Adjuvant Therapy in Primary Breast Cancer E: T3 Nonspecific; ER-; N-; Entry JUN-1987 to DEC-1989 (nonstandard randomisation; not received)

1 Colchicine + Uraphetine
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

12908 87F8 Randomised Clinical Trial of Adjuvant Therapy in Primary Breast Cancer F: T3 Specific; ER+; N-; Entry JUN-1987 to DEC-1989 (nonstandard randomisation; not received)

1 Tamoxifen [20mg/d] indefinitely
2 Control

12909 Perioperative CU Adjuvant Chemotherapy in Operable Breast Cancer: Entry 1980 to 1981 (nonstandard randomisation; not received)

1 (Colchicine + Uraphetine) perioperative
2 Control

130 French Adjuvant Study Group {Bardonnet-Comte, Bobin, Bonnetere, Bremond, Fumoleau, Gerard, Hery, Hurteloup, Mercier, Namer, Roche, Schraub: MAY-2000 (SECOND REVISED VERSION)}

13001 86P1 GFEA 01 (Hurteloup, Fumoleau, Mercier): Premenopausal; N+; Entry JUL-1986 to JUL-1990 (621 patients were entered)

1 (4-Epi-Doxorubicin [50mg/m² iv] + 5-Fluoro-Uracil + Cyclophosphamide) × 3 then Radiotherapy then (4-Epi-Doxorubicin [50mg/m² iv] + 5-Fluoro-Uracil + Cyclophosphamide) × 3
2 (4-Epi-Doxorubicin [50mg/m² iv] + 5-Fluoro-Uracil + Cyclophosphamide) × 3 then Radiotherapy
3 (4-Epi-Doxorubicin [75mg/m² iv] + 5-Fluoro-Uracil + Cyclophosphamide) × 3 then Radiotherapy

13002 86P2 GFEA 02 (Hurteloup, Namer, Mercier): Postmenopausal; N+; Entry JUL-1986 to JUL-1990 (776 patients were entered)

1 Radiotherapy + Tamoxifen [30mg/d] × 3yr
2 (4-Epi-Doxorubicin + 5-Fluoro-Uracil + Cyclophosphamide) × 3 then Radiotherapy then (4-Epi-Doxorubicin + 5-Fluoro-Uracil + Cyclophosphamide) × 3
3 (4-Epi-Doxorubicin + 5-Fluoro-Uracil + Cyclophosphamide) × 3 then Radiotherapy then (4-Epi-Doxorubicin + 5-Fluoro-Uracil + Cyclophosphamide) × 3 + Tamoxifen [30mg/d] × 3yr
4 Radiotherapy

13003 86P3 GFEA 03 (Hurteloup, Hery, Schraub, Mercier): Premenopausal/Postmenopausal; N-; Entry OCT-1988 to DEC-1994 (328 patients were entered)

1 (4-Epi-Doxorubicin + 5-Fluoro-Uracil + Cyclophosphamide) × 6
2 Control

13004 90C1 GFEA 04 (Hurteloup, Gerard, Bremond, Bobin, Mercier): Premenopausal/Postmenopausal; Tumour > 3cm; N-; Entry 1990 ff. (not received)

1 (4-Epi-Doxorubicin + 5-Fluoro-Uracil + Cyclophosphamide) × 3 preoperative
2 (4-Epi-Doxorubicin + 5-Fluoro-Uracil + Cyclophosphamide) × 3 postoperative

13005 90C2 GFEA 04 (Hurteloup, Gerard, Bremond, Bobin, Mercier): Premenopausal/Postmenopausal; Tumour > 3cm; N+; Entry APR-1990 to JUL-1993 (565 patients were entered; not received)

1 (4-Epi-Doxorubicin + 5-Fluoro-Uracil + Cyclophosphamide) × 3 preoperative then (4-Epi-Doxorubicin + 5-Fluoro-Uracil + Cyclophosphamide) × 3 postoperative
2 (4-Epi-Doxorubicin + 5-Fluoro-Uracil + Cyclophosphamide) × 6 postoperative

13006 90C3 GFEA 05 (Hurteloup, Bonnetere, Mercier): Premenopausal; N+; SBR III; ER-/PR-; Age < 65; Entry APR-1990 to JUN-1993 (298 patients were entered)

1 (4-Epi-Doxorubicin [50mg/m²] + 5-Fluoro-Uracil + Cyclophosphamide) × 6
2 (4-Epi-Doxorubicin [100mg/m²] + 5-Fluoro-Uracil + Cyclophosphamide) × 6

13007 90C4 GFEA 06 (Hurteloup, Roche, Mercier): Premenopausal; Age < 50; N1-3; ER+; PR+; Entry JUL-1990 to SEP-1998 (333 patients were entered)

1 Buserelin × 3yr + Tamoxifen [30mg/d] × 3yr
2 (4-Epi-Doxorubicin + 5-Fluoro-Uracil + Cyclophosphamide) × 6

13008 90C5 GFEA 05 (Hurteloup, Bonnetere, Mercier): Postmenopausal; N+; SBR III; ER-/PR-; Age < 65; Entry APR-1990 to JUL-1993 (267 patients were entered)

1 (4-Epi-Doxorubicin [50mg/m²] + 5-Fluoro-Uracil + Cyclophosphamide) × 6 + Tamoxifen [30mg/d] × 3yr
2 (4-Epi-Doxorubicin [100mg/m²] + 5-Fluoro-Uracil + Cyclophosphamide) × 6 + Tamoxifen [30mg/d] × 3yr

13009 90C6 GFEA 07: Postmenopausal; Age 51-64; N1-3; ER+; PR+; Entry JAN-1991 to AUG-1998 (335 patients were entered)

1 Tamoxifen [30mg/d] × 3yr
2 (4-Epi-Doxorubicin [50mg/m²] + 5-Fluoro-Uracil + Cyclophosphamide) × 6 + Tamoxifen [30mg/d] × 3yr

13010 90C7 GFEA 08: Postmenopausal; Age 66+; N+; Entry MAR-1991 to OCT-1999 (326 patients were entered)

1 Tamoxifen [30mg/d] × 3yr
2 4-Epi-Doxorubicin [50mg/m²] × 6 + Tamoxifen [30mg/d] × 3yr

13011 90C8 GFEA 09: Premenopausal/Postmenopausal; N+; Entry JUN-1993 to APR-1998 (482 patients were entered)

1 (4-Epi-Doxorubicin [100mg/m²] + 5-Fluoro-Uracil + Cyclophosphamide) × 6
2 (4-Epi-Doxorubicin [50mg/m²] + Vinorelbine [25mg/m²]) × 6

131 C.I.O., Buenos Aires, Argentina {de Botto, Vico: AUG-1986}

13101 CMF, Radiotherapy and Tamoxifen Trial: Postmenopausal; N+; Stage II; Entry JAN-1978 to SEP-1981 (not randomised; not received)

1 Radiotherapy
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 + Tamoxifen [20mg/d] × 1yr

13102 FAC, Radiotherapy and BCG Trial: N+; Stage II; Entry ?1979 ff. (not randomised; not received)

1 Radiotherapy
2 5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide
3 5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide + Bacillus Calmette-Guèrin

132 Marseille, France {Aymé, Bardou, Martin, Romain: MAY-1990}

13201 80H1 High Risk Stage I-III: N+; Premenopausal; Entry FEB-1980 to AUG-1984 (76 patients were entered)

1 Triethylenephosphoramide × 3d perioperative + (Vincristine + Cyclophosphamide + 5-Fluoro-Uracil) × 18
2 Triethylenephosphoramide × 3d perioperative + (Vincristine + Cyclophosphamide + 5-Fluoro-Uracil) × 18 + Tamoxifen [30mg/d] × 3yr + Oöphorectomy
3 Triethylenephosphoramide × 3d perioperative + Tamoxifen [30mg/d] × 3yr + Oöphorectomy

13202 80H2 High Risk Stage I-III: N+; Postmenopausal; Entry FEB-1980 to DEC-1984 (107 patients were entered)

1 Triethylenephosphoramide × 3d perioperative + (Vincristine + Cyclophosphamide + 5-Fluoro-Uracil) × 18
2 Triethylenephosphoramide × 3d perioperative + (Vincristine + Cyclophosphamide + 5-Fluoro-Uracil) × 18 + Tamoxifen [30mg/d] × 3yr
3 Triethylenephosphoramide × 3d perioperative + Tamoxifen [30mg/d] × 3yr

133 Vienna University Hospital 1st. Department of Gynaecology, Austria {Krainer, Sevelda, Zielinski: MAR-2001 (UPDATED FIVE TIMES)}

13301 80J1 Trial 1: Postmenopausal; Age 50-72; N+; Stage II; Entry OCT-1980 to JUL-1985 (95 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 Tamoxifen [10mg bd] × 1yr
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 + Tamoxifen [10mg bd] × 1yr

13302 80J2 Trial 2: Postmenopausal; Age 50-75; N-; Entry SEP-1980 to NOV-1985 (99 patients were entered)

1 Tamoxifen [10mg bd] × 1yr
2 Control

13303 85N1 Vienna: ER+/PR+; N+; Entry NOV-1985 to NOV-1988 (68 patients were entered)

1 (4-Epi-Doxorubicin + Cyclophosphamide) intraoperative then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 + Tamoxifen [20mg/d] × 2yr
2 (4-Epi-Doxorubicin + Cyclophosphamide) [d22] postoperative then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 + Tamoxifen [20mg/d] × 2yr

13304 85N2 Vienna: ER-; PR-; N+; Entry NOV-1985 to SEP-1988 (21 patients were entered)

1 (4-Epi-Doxorubicin + Cyclophosphamide) intraoperative then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3
2 (4-Epi-Doxorubicin + Cyclophosphamide) [d22] postoperative then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3

13305 85N3 Vienna: ER+/PR+; N-; Entry DEC-1985 to DEC-1988 (85 patients were entered)

1 (4-Epi-Doxorubicin + Cyclophosphamide) intraoperative + Tamoxifen [20mg/d] × 2yr
2 (4-Epi-Doxorubicin + Cyclophosphamide) [d22] postoperative + Tamoxifen [20mg/d] × 2yr

13306 85N4 Vienna: ER-; PR-; N-; Operable; Entry OCT-1985 to OCT-1988 (29 patients were entered)

1 (4-Epi-Doxorubicin + Cyclophosphamide) intraoperative
2 (4-Epi-Doxorubicin + Cyclophosphamide) [d22] postoperative

134 Kawasaki Medical School, Kurashiki, Japan {Senoo, Sonoo: AUG-1990}

13401 Trial 1: Entry ? (100 patients were entered; not received)

1 Control
2 Tamoxifen × 1yr

13402 84S1 Trial 2: Stage I; ER+/ER?; Entry MAR-1984 to DEC-1985 (20 patients were entered)

1 (Uracil + Ftorafur + Tamoxifen [20mg/d]) × 1yr
2 (Uracil + Ftorafur) × 1yr

13403 84S2 Trial 2: Stage I; ER-; Entry MAR-1985 to MAY-1985 (3 patients were entered)

1 (Uracil + Ftorafur + Basidiomycetes Protein Polysaccharide) × 1yr
2 (Uracil + Ftorafur) × 1yr

135 Gruppo Interdisciplinare Valutazione Interventi in Oncologia (GIVIO), Italy {Fossati, Liberati, Mari, Nicolucci: JUN-2000 (THIRD REVISED VERSION)}

13501 89A1 Protocol SITAM-01: Low Risk; Age 50-70; (all N-)/(N1-3, ER+); Postmenopausal; Randomisation at 2-year point; Entry JUL-1989 to DEC-1998 (1429 patients were entered)

1 Tamoxifen [20mg/d] × 2yr
2 Tamoxifen [20mg/d] × 5yr

13502 89A2 Protocol SITAM-01: High Risk; Age 50-70; (N+, ER-)/(N4+, ER+/ER?); Postmenopausal; Optional initial randomisation; Entry MAR-1989 to APR-1995 (115 patients were entered)

1 (Cyclophosphamide [100mg/m² po d1-14] / Cyclophosphamide [600mg/m² iv d1,14] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q28d × 6 then Tamoxifen [20mg/d] × 2yr
2 Tamoxifen [20mg/d] × 2yr

13503 89A3 Protocol SITAM-01: High Risk; Age 50-70; (N+, ER-)/(N4+, ER+/ER?); Postmenopausal; Randomisation at 2-year point; Entry JUL-1989 to MAR-1998 (526 patients were entered)

1 Tamoxifen [20mg/d] × 2yr
2 Tamoxifen [20mg/d] × 5yr

13504 Efficacy of Periodic Follow-Up: Entry SEP-1986 to JUL-1988 (1441 patients were entered; not received)

1 Control
2 Intensive Follow-Up

13505 91K1 Protocol SITAM-02: Age < 50; Entry JAN-1991 to NOV-1996 (316 patients were entered)

1 Control
2 Tamoxifen [20mg/d] × 2yr
3 Goserelin × 2yr
4 (Goserelin + Tamoxifen [20mg/d]) × 2yr

13506 91K2 Protocol SITAM-02: N+; Age < 50; Entry JAN-1991 to OCT-1996 (81 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 then Tamoxifen [20mg/d] × 2yr
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 then Goserelin × 2yr
4 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 then (Goserelin + Tamoxifen [20mg/d]) × 2yr

136 London Guy's Hospital, U.K. {Bentley, Doran, Fentiman, Rubens, Smith, Sylvester: JUN-2000 (REVISED VERSION)}

13601 85P1 EORTC 10850 (Fentiman): Age 75+; Entry SEP-1985 to OCT-1991 (236 patients were entered)

1 Modified Radical Mastectomy
2 Tumorectomy + Tamoxifen [20mg/d] for life

13602 85P2 EORTC 10851 (Fentiman): Age 75+; Entry OCT-1985 to NOV-1991 (177 patients were entered)

1 Modified Radical Mastectomy
2 Tamoxifen [20mg/d] for life

13603 84H Bromocriptine (Fentiman): Entry NOV-1984 to OCT-1985 (38 patients were entered)

1 Bromocriptine preoperative
2 Control

13604 EORTC 10853 (Fentiman): DCIS; Local Excision; Age < 70; Entry MAR-1986 to JUN-1996 (1010 patients were entered)

1 Control
2 Radiotherapy

13605 85L2 Guy's and Manchester (Guy's part - Fentiman): Stage II; N+; Postmenopausal; Age < 70; Entry MAY-1986 to MAR-1992 (269 patients were entered; Manchester part is 3405)

1 Tamoxifen
2 Tamoxifen + Prednisolone

13606 Drain Removal Timing Trial: Drainage Endpoint; Entry ? (not received)

1 Drain Removal 3d postoperative
2 Drain Removal 6d postoperative

137 Streekarchenhuis Koningin Beatrix, Netherlands {Jonk: JUN-1989}

13701 Surgery using Human Fibrin-Glue: Drainage Endpoint; Entry 1986 to 1987 (not received)

1 Control
2 Fibrin-Glue

138 American Health Foundation, U.S.A. {Wynder: JUN-1989}

13801 87K1 Nutrition Adjuvant Study (Pilot): Stage II; N+; Postmenopausal; Age 50-75; Weight Endpoint; Entry ?1987 (49 patients were entered; abandoned)

1 Control
2 Intensive intervention to lower fat intake

13802 87K2 Women's Intervention Nutrition Study: Postmenopausal; Weight Endpoint; Entry NOV-1988 ff. (not received)

1 Control
2 Intensive intervention to lower fat intake

139 Tokyo National Cancer Center, Japan {Watanabe, Yamamoto: JUN-1989}

13901 Group 2: Age < 66; (pT2 pN0)/(pT3 pN0)/(TX pN0); Entry 1983 to 1987 (date-of-birth allocations; not received)

1 Cyclophosphamide × 1yr
2 (Cyclophosphamide + Ftorafur) × 1yr

13902 Group 3: Age < 66; (pT1 pN+)/(pT2 pN(1-3 positive))/(TX pN(1-3 positive)); Entry 1983 to 1987 (date-of-birth allocations; not received)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12
2 (Cyclophosphamide + Ftorafur) × 1yr

13903 Group 4: Age < 66; 'others'; Entry 1983 to 1987 (date-of-birth allocations; not received)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Doxorubicin) × 12
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Doxorubicin) × 12 + Tamoxifen [30mg/d] × 2yr

13904 88T1 Adjuvant Therapy for Node Positive Breast Cancer: N+; Age < 66; Premenopausal; Entry 1988 ff. (not received)

1 (Cyclophosphamide [65mg/m² iv] + Methotrexate [13mg/m² iv] + 5-Fluoro-Uracil [300mg/m² iv] + Doxorubicin [13mg/m² iv]) × 12 + Tamoxifen [30mg/d po] × 2yr
2 (Cyclophosphamide [130mg/m² iv] + Methotrexate [26mg/m² iv] + 5-Fluoro-Uracil [600mg/m² iv] + Doxorubicin [26mg/m² iv]) × 6 + Tamoxifen [30mg/d po] × 2yr

13905 88T2 Adjuvant Therapy for Node Positive Breast Cancer: N+; Age < 66; Postmenopausal; Entry 1988 ff. (not received)

1 Tamoxifen [30mg/d] × 2yr
2 Medroxyprogesterone Acetate [600mg/d po] × 2yr

13906 95G (Watanabe): High Risk; Premenopausal (mainly); M0; Entry ?1995 ff. (not received)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Tamoxifen
2 (Uracil + Ftorafur) [po] + Tamoxifen

140 Washington University Mallinckrodt Institute of Radiology, U.S.A. {Fowble, Perez: JUN-1989}

14001 Conservation Surgery and Irradiation in Early Breast Carcinoma: Entry ? (295 patients were entered; not received)

1 Electron Beam
2 Interstitial Implant

141 Ontario Clinical Oncology Group, Canada {Chambers, Clark, Levine, Skingley: JUN-2000 (SECOND REVISED VERSION)}

14101 83Q O.C.O.G. Randomised Controlled Trial for Operable High-Risk Breast Carcinoma (Levine): Stage II; N+; Entry NOV-1983 to MAY-1987 (437 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + V + P + Doxorubicin + Tamoxifen) × 12wk
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + V + P) × 36wk

14103 84P O.C.O.G. (Clark): Stage I; Partial Mastectomy; N-; Entry APR-1984 to FEB-1989 (837 patients were entered)

1 Radiotherapy
2 Control

142 Hôpital Salpétrière, Paris, France {Jacquillat: JUN-1994}

14201 Salpétrière: Age < 75; N0; Entry ? (not randomised; not received)

1 Control
2 Melphalan

14202 Salpétrière: Age < 75; N1-3; Entry ? (not randomised; not received)

1 Melphalan
2 V + Methotrexate + 5-Fluoro-Uracil + Triethylenephosphoramide + Streptonigrin

14203 Salpétrière: Age < 75; N4+; Entry ? (not randomised; not received)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + V + Pr

14204 Tamoxifen with Neoadjuvant Chemotherapy: Premenopausal; Entry 1980 to 1986 (not randomised; not received)

1 (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil + V + Pr) then Radiotherapy [locoregional]
2 (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil + V + Pr) then Radiotherapy [locoregional] + Tamoxifen [30mg/d] × 3yr

14205 Tamoxifen with Neoadjuvant Chemotherapy: High Risk; Premenopausal; Entry 1980 to 1986 (not randomised; not received)

1 (Doxorubicin + Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil + V + Pr) then Radiotherapy [locoregional]
2 (Doxorubicin + Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil + V + Pr) then Radiotherapy [locoregional] + Tamoxifen [30mg/d] × 3yr

14206 Tamoxifen with Neoadjuvant Chemotherapy: Aggressive Cancer; Stage I; Entry 1986 ff. (not randomised; not received)

1 (Cis-Platinum + VP-16 + 5-Fluoro-Uracil + Mitomycin-C) × 3 then (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil + V + Pr) then Radiotherapy [locoregional]
2 (Cis-Platinum + VP-16 + 5-Fluoro-Uracil + Mitomycin-C) × 3 then (Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil + V + Pr) then Radiotherapy [locoregional] + Tamoxifen

14207 Tamoxifen with Neoadjuvant Chemotherapy: Aggressive Cancer; Stage II+; Entry 1986 ff. (not randomised; not received)

1 (Cis-Platinum + VP-16 + 5-Fluoro-Uracil + Mitomycin-C) × 3 then (Doxorubicin + Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil + V + Pr) then Radiotherapy [locoregional]
2 (Cis-Platinum + VP-16 + 5-Fluoro-Uracil + Mitomycin-C) × 3 then (Doxorubicin + Triethylenephosphoramide + Methotrexate + 5-Fluoro-Uracil + V + Pr) then Radiotherapy [locoregional] + Tamoxifen

14208 Local Radiotherapy Trial: Entry JAN-1980 to OCT-1987 (136 patients were entered; not received; not adjuvant)

1 Control
2 Radiotherapy [45Gy in 5wk or (2d × 2/m) × 2 local]

143 Centro Oncologico, Trieste, Italy {Mustacchi: JUN-2001 (SECOND REVISED VERSION)}

14301 87G GRETA: Early Breast Cancer; T1-3a N0-1 M0; Postmenopausal; Age 71+; Entry MAR-1987 to NOV-1992 (474 patients were entered {should not be stratified for ER/PR status})

1 Mastectomy + Tamoxifen [20mg bd]
2 Tamoxifen [160mg d1] then Tamoxifen [20mg bd]

144 Buenos Aires Instituto Nacional de Oncologia 'Angel H. Roffo', Argentina {Alvarez, Hecker: JUN-1989}

14401 __B1 Buenos Aires: Stage II; N+; ER+; Premenopausal; Entry ? (36 patients were entered; synthetic data only; no recurrence information)

1 Oöphorectomy + Tamoxifen + Medroxyprogesterone Acetate
2 V + Doxorubicin + Cyclophosphamide

14402 __B2 Buenos Aires: Stage II; N+; ER+; Postmenopausal; Entry ? (37 patients were entered; synthetic data only; no recurrence information)

1 Tamoxifen + Medroxyprogesterone Acetate
2 V + Doxorubicin + Cyclophosphamide

14403 Advanced Disease (Alvarez): Entry ? (not received)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 Methotrexate + 5-Fluoro-Uracil

145 Arbeitskreis für Perioperative Chemotherapie, Vienna, Austria {Rainer, Politzer, Wildauer: SEP-1990}

14501 Chemohormonotherapy Versus Radiotherapy (Advanced Disease): Premenopausal/Postmenopausal; N0/N+; Age < 71; ER-/ER+; PR-/PR+; Entry DEC-1983 to DEC-1988 (176 patients were entered; not received)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + V + Mitozantrone + Tamoxifen) preoperative/postoperative
2 Radiotherapy preoperative (and postoperative for non-responders)

146 Genova Istituto Nazionale per la Ricerca sul Cancro, Italy {Bertelli, Bruzzi, Sertoli: MAY-2000 (REVISED VERSION)}

14601 85C1 Postoperative Chemotherapy Trial: N+; Age < 65; Entry MAY-1985 to JUN-1992 (431 patients were entered)

1 ((Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) / (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil)) × 12 alternating + Tamoxifen (concomitant)
2 ((Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) / (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil)) × 12 alternating + Tamoxifen (sequential)

14602 85C2 Perioperative Chemotherapy Trial: Clinical Stage I; N-; Age < 65; Entry MAY-1985 to JUN-1992 (322 patients were entered)

1 (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) perioperative
2 Control

14603 85C3 Perioperative Chemotherapy Trial: N+; Age < 65; Entry MAY-1985 to JUL-1992 (278 patients were entered)

1 (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) perioperative then ((Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) / (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil)) × 12 alternating + Tamoxifen
2 ((Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) / (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil)) × 12 alternating + Tamoxifen

14604 Antiemetic Trial: Vomiting Endpoint; Entry OCT-1983 to MAR-1984 (not received)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Methylprednisolone) × 12
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Metoclopramide) × 12

14605 Pneumatic Compression Trial: Mild or Moderate Postmastectomy Lymphoedema; Oedema Endpoint; Entry JAN-1989 ff. (not received)

1 Maintenance Pneumatic Compression
2 Control

14606 86J Genova-Turin Trial: Entry 1986 ff. (92 patients were entered; closed early; not received; data not retrievable)

1 Modified Radical Mastectomy
2 Wide Excision + Axillary Dissection + Radiotherapy

14607 92E1 Genova: N+/(N-, High Risk); ER-; Entry NOV-1992 to JUN-1997 (537 patients were entered)

1 (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) q21d × 6
2 (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) q14d × 6

14608 92E2 Genova: ER+; Entry NOV-1992 to JUN-1997 (656 patients were entered)

1 (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) q21d × 6 + Tamoxifen [20mg/d] concurrent
2 (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) q14d × 6 + Tamoxifen [20mg/d] concurrent

14609 92E3 Genova: N+; ER?; Entry FEB-1993 to NOV-1996 (21 patients were entered)

1 (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) q21d × 6 + Tamoxifen [20mg/d] concurrent
2 (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) q14d × 6 + Tamoxifen [20mg/d] concurrent

147 Sardinia Oncology Hospital A. Businico {Demontis, Deshpande, di Martino, Mitchell: JUN-1990 (REVISED VERSION)}

14701 84E SAITAI Trial: High Risk; Postmenopausal; Entry MAR-1984 to FEB-1990 (120 patients were entered)

1 Tamoxifen [20mg bd]
2 Tamoxifen [20mg bd] + Prednisolone

148 Liverpool University, U.K. {George, Holt, Leinster, Winstanley: JUN-1989}

14801 79P Liverpool: Age < 70; Entry APR-1979 to MAY-1984 (157 patients were entered; synthetic data only; no recurrence information)

1 Control
2 (Cyclophosphamide + Doxorubicin + Vincristine + Tamoxifen [20mg bd]) × 6m

14802 Patient-Choice Trial: Entry ? (80 patients were entered; not received)

1 Patient's treatment choice
2 Surgeon's treatment choice

149 Nottingham City Hospital, U.K. {Blamey, Moloney, Morgan, Robertson, Williams: JUN-2000 (REVISED VERSION)}

14901 Stage III: Postmenopausal; No Surgery; Entry ? (90 patients were entered; not received)

1 Tamoxifen [20mg bd]
2 Radiotherapy

14902 82V Nottingham: Age 70+; Postmenopausal; Entry 1982 to 1987 (131 patients were entered; no date information)

1 Tamoxifen [20mg bd]
2 Wedge Mastectomy

14903 89Q Nottingham: ER+; Age 70+; Entry 1989 ff. (not received)

1 Tamoxifen
2 Surgery + Tamoxifen

14904 85F Grade III: Mastectomy with Axillary Sampling; N+; Entry SEP-1985 to FEB-1991 (82 patients were entered; 5 missing)

1 Control
2 Radiotherapy [45Gy in 15 fractions]

150 London St George's Hospital, U.K. {Gazet, Sutcliffe: SEP-2000 (REVISED VERSION, UPDATED)}

15001 82W St George's: Age 70+; Entry JAN-1982 to JAN-1990 (200 patients were entered)

1 Tamoxifen [20mg/d] × 2yr
2 Mastectomy / Local Excision

15002 82Y1 T1/T2 Study: ER-; N-; Premenopausal; Entry FEB-1982 to FEB-1990 (45 patients were entered; additional exclusions missing)

1 Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6

15003 82Y2 T1/T2 Study: ER-; N+; Premenopausal; Entry JUL-1982 to FEB-1990 (25 patients were entered; additional exclusions missing)

1 Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6

15004 82Y3 T1/T2 Study: ER+; N-; Premenopausal; Entry JAN-1982 to MAR-1990 (75 patients were entered; additional exclusions missing)

1 Radiotherapy + Tamoxifen [20mg/d] × 2yr
2 Tamoxifen [20mg/d] × 2yr

15005 82Y4 T1/T2 Study: ER+; N+; Premenopausal; Entry JAN-1982 to SEP-1989 (50 patients were entered; additional exclusions missing)

1 Radiotherapy + Tamoxifen [20mg/d] × 2yr
2 Tamoxifen [20mg/d] × 2yr

15006 82Y5 T1/T2 Study: ER-; N-; Postmenopausal; Entry AUG-1984 to JAN-1990 (32 patients were entered; additional exclusions missing)

1 Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6

15007 82Y6 T1/T2 Study: ER-; N+; Postmenopausal; Entry NOV-1983 to NOV-1989 (21 patients were entered; additional exclusions missing)

1 Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6

15008 82Y7 T1/T2 Study: ER+; N-; Postmenopausal; Entry FEB-1983 to FEB-1990 (98 patients were entered; additional exclusions missing)

1 Radiotherapy + Tamoxifen [20mg/d] × 2yr
2 Tamoxifen [20mg/d] × 2yr

15009 82Y8 T1/T2 Study: ER+; N+; Postmenopausal; Entry JUN-1982 to FEB-1990 (54 patients were entered; additional exclusions missing)

1 Radiotherapy + Tamoxifen [20mg/d] × 2yr
2 Tamoxifen [20mg/d] × 2yr

15010 90E1 Pre- Versus Postoperative Chemotherapy (Coombes, Gazet, Ford): T1-4; ER-; Entry APR-1990 to JUL-1993 (about 100 patients were entered; not received)

1 Chemotherapy preoperative
2 Chemotherapy postoperative

15011 90E2 Pre- Versus Postoperative Chemotherapy (Coombes, Gazet, Ford): T1-4; ER+; Entry APR-1990 to JUL-1993 (about 100 patients were entered; not received)

1 Endocrine Therapy preoperative
2 Endocrine Therapy postoperative

151 St Vincent's Hospital, New York, U.S.A. {Kemeny: JUN-1989}

15101 Overlapping part of NSABP B-06: Entry JUL-1980 to JAN-1984 (not received)

1 Total Mastectomy
2 Total Mastectomy + Chemotherapy
3 Segmental Mastectomy + Radiotherapy
4 Segmental Mastectomy + Radiotherapy + Chemotherapy
5 Segmental Mastectomy
6 Segmental Mastectomy + Chemotherapy

152 Central Oncology Group, Wisconsin, U.S.A. {Davis: FEB-1991}

15201 75P COG Wisconsin: N+; Entry JAN-1975 to DEC-1978 (272 patients were entered; synthetic data only; no recurrence information; 18 patients missing; no more information available)

1 Melphalan × 1yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Vincristine) × 1yr

153 Ontario Cancer Institute, Toronto, Canada {Boyd: JAN-1995}

15301 Mammary Dysplasia Endpoint Trial: Entry ? to 1997 (2100 patients were entered by JAN-1995; not received)

1 Control
2 Reduced-Fat Diet

154 North-Western British Surgeons, U.K. {Lister, Lythgoe, Ribeiro, Swindell, Turner: MAR-2001 (SECOND REVISED VERSION, UPDATED FIVE TIMES)}

15401 69D Lister Trial (Turner): Stage I-II; Entry SEP-1969 to SEP-1976 (534 patients were entered)

1 Radical Mastectomy
2 Modified Radical Mastectomy

15402 70A1 Regional Breast Study 1 (Lythgoe): Manchester Regional Stage I; Simple Mastectomy; Entry MAR-1970 to OCT-1975 (714 patients were entered)

1 Control
2 Radiotherapy

15403 70A2 Regional Breast Study 2 (Lythgoe): Manchester Regional Stage II; Entry MAR-1970 to OCT-1975 (308 patients were entered)

1 Radical Mastectomy
2 Radiotherapy + Simple Mastectomy

155 Cardiff Surgery Trialists, Wales {Forrest, Horgan, Roberts, Sillwood, Stewart: JUN-2000 (UPDATED SIXTEEN TIMES)}

15501 67B Cardiff Trial (Roberts) - Radical vs. Conservative Policy: Entry SEP-1967 to JUN-1973 (200 patients were entered)

1 Radical Mastectomy + (Radiotherapy [to chest wall] + Radiotherapy [to axilla] + Radiotherapy [to internal chain] only for N+)
2 Simple Mastectomy + Node Sampling + (Radiotherapy [to axilla] only for N+)

156 Oregon Health Science University, U.S.A. {Peterson: JUN-1989}

15601 Oregon: Entry 1940 to 1965 (148 patients were entered; nonstandard randomisation; synthetic data only; no recurrence information)

1 Radical Mastectomy
2 Ultra-Radical Mastectomy

157 Cambridge Addenbrooke's Hospital, U.K. {Brinkley, Haybittle: JUN-2000 (UPDATED THIRTEEN TIMES)}

15701 58B Stage II: Entry OCT-1958 to MAY-1965 (233 patients were entered)

1 Simple Mastectomy + Radiotherapy
2 Radical Mastectomy + Radiotherapy

158 Charing Cross Hospital, London, U.K. {Burn: JUN-1989}

15801 65C Hammersmith Trial: Entry JUL-1965 to JUN-1970 (195 patients were entered; synthetic data only; no events; no recurrence information; 43 patients missing)

1 Simple Mastectomy + Radiotherapy
2 Radical Mastectomy + Radiotherapy

159 Ostersund Hospital, Sweden {Christensen: JUN-1989}

15901 85Q Surgery Trial: Arm Oedema and Lymph Node Classification Endpoints; Entry MAY-1985 to APR-1987 (100 patients were entered; not received)

1 Axillary Clearance
2 Axillary Sampling

160 Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy {Galli: JUN-1989}

16001 Breast Reconstruction Following Radical Mastectomy: Cosmetic Outcome Endpoint; Entry 1984 to 1986 (42 patients were entered; synthetic data only; no recurrence information)

1 Transposition of Latissimus Dorsi Flap + Prosthesis
2 Transposition of Transverse Rectus Abdominus Flap

161 Cape Town Groote Schuur Hospital, Republic of South Africa {Dent, Gudgeon, Hacking, Helman, Murray, Werner: JUN-2000 (UPDATED SIX TIMES)}

16101 67C1 Prospective Trial: Stage I; T1-2 N0 M0; 1:2 Randomisation; Entry JUL-1967 to JUL-1971 (51 patients were entered)

1 Radical Mastectomy
2 Simple Mastectomy

16102 67C2 Prospective Trial: Stage II; T1-2 N1 M0; Entry SEP-1968 to SEP-1971 (47 patients were entered)

1 Radical Mastectomy
2 Simple Mastectomy + Axillary Biopsy

162 Institut Gustave-Roussy, Villejuif, France {Arriagada, Bonneterre, Hill, Lacour, Laplanche, Luboinski, May-Levin, Sarrazin, Spielmann, Spira: MAR-2000 (REVISED VERSION)}

16201 72F pA-pU Trial: Entry MAR-1972 to DEC-1979 (300 patients were entered)

1 Control
2 Polyadenylic-Polyuridylic Acid

16202 82X CMF and R + pA-pU Trial: N+; Entry MAR-1982 to JAN-1986 (517 patients were entered)

1 Radiotherapy + Polyadenylic-Polyuridylic Acid
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m

16203 63D1 Gustave-Roussy part of International Coöperative Study: Entry SEP-1963 to MAR-1968 (243 patients were entered)

1 Radical Mastectomy
2 Radical Mastectomy + Internal Mammary Dissection

16204 89C1 FNCLCC Trial: Entry JAN-1989 to FEB-1998 (435 patients were entered)

1 Chemotherapy
2 (Ovarian Irradiation / Oöphorectomy) + Chemotherapy

16207 89D1 Chemotherapy Trial: Premenopausal; N-; Entry MAR-1989 to JAN-1996 (314 patients were entered)

1 Control
2 (5-Fluoro-Uracil + Doxorubicin/4-Epi-Doxorubicin + Cyclophosphamide) × 6

16208 89D2 Chemotherapy Trial: Postmenopausal; Entry MAR-1989 to MAR-1996 (837 patients were entered)

1 Tamoxifen × 2yr
2 (5-Fluoro-Uracil + Doxorubicin/4-Epi-Doxorubicin + Cyclophosphamide) × 6 + Tamoxifen × 2yr

16209 72G Surgery and Radiotherapy Trial: Age < 70; Entry OCT-1972 to SEP-1979 (179 patients were entered)

1 Tumorectomy + Radiotherapy [to breast]
2 Total Mastectomy

16210 Tumorectomy (second randomisation from 16209): Age < 70; Axillary Clearance; N+; Entry JAN-1973 to AUG-1980 (72 patients were entered; some additional exclusions missing; nonstandard randomisation)

1 Radiotherapy [megavoltage to breast]
2 Radiotherapy [megavoltage to breast] + Radiotherapy [megavoltage to nodes]

16211 94H FNCLCC Radiotherapy Trial: N+; Entry 1994 ff. (250 patients were entered by 1997; not received)

1 (5-Fluoro-Uracil + Mitozantrone + Cyclophosphamide) q3wk × 4 + Radiotherapy (concurrent)
2 (5-Fluoro-Uracil + 4-Epi-Doxorubicin + Cyclophosphamide) q3wk × 4 then Radiotherapy (sequential)

16212 89C2 FNCLCC Trial: Entry JAN-1989 to JUL-1996 (491 patients were entered)

1 Chemotherapy
2 Buserelin/Goserelin + Chemotherapy

163 Chicago University, U.S.A. {Meier: JAN-1995 (UPDATED TWICE)}

16301 73D Surgery Trial: Stage I-II; Age < 70; Entry NOV-1973 to JUL-1982 (123 patients were entered)

1 Radical Mastectomy
2 Extended Radical Mastectomy

164 University of Leiden, Netherlands {de Haes: JUN-1989}

16401 Leiden: Entry JAN-1981 to JAN-1982 (40 patients were entered; subset of E.O.R.T.C. Trial 10801 - 'on ice'; not received)

1 Mastectomy
2 Tumorectomy + Radiotherapy

165 National Cancer Institute, Bethesda, U.S.A. {d'Angelo, Jacobson, Kunieff, Lippman, Steinberg: MAY-2001 (SECOND REVISED VERSION, UPDATED)}

16501 79J Radiation Oncology Branch Protocol 79-C-111: Stage I-II; Entry JUL-1979 to MAR-1988 (249 patients were entered)

1 Mastectomy + Axillary Dissection
2 Lumpectomy + Axillary Dissection + Radiotherapy

16502 Physiotherapy Trial - Breast Cancer Patients With Axillary Dissection: Drainage Endpoint; Entry 1979 to 1980 (21 patients were entered; not received; not required for overview; trial also includes additional melanoma patients)

1 Early Arm Motion
2 Delayed Arm Motion

16503 N.C.I. Women's Health Trial: > 38% calories from fat; (1+ 1st-degree relatives with breast cancer) / (2+ previous biopsies) / (1st birth aged 25+ years) / (nulliparous); Not Adjuvant; Entry ? (not received)

1 Low-Fat Diet Intervention
2 Control

16504 90U Pre- Versus Postoperative Chemotherapy Trial: Stage II; Entry AUG-1990 to AUG-1998 (53 patients were entered)

1 Chemotherapy preoperative
2 Chemotherapy postoperative

16505 93F GM-CSF Trial: Stage II-III Subset; Entry JUN-1993 to DEC-1994 (22 patients were entered)

1 Chemotherapy then GM-Colony Stimulating Factor
2 Chemotherapy then PIXY321

16506 Phase III Fenretinide Trial: N+; Postmenopausal; ER+; PR+; Entry 1996 ff. (duplicated as 7517; not received)

1 Tamoxifen [20mg/d]
2 Tamoxifen [20mg/d] + Fenretinide [400mg/d, 3d holiday per month]

167 London St Thomas' Hospital, U.K. {Bates: JUN-1989}

16701 68A Radiotherapy: Entry 1968 to 1974 (411 patients were entered; synthetic data only; no recurrence information)

1 Radiotherapy × 6 in 18d
2 Radiotherapy × 12 in 28d

169 Cheltenham General and Royal Marsden Hospitals, U.K. {Owen, Yarnold: NOV-1989}

16901 80U1 Radiotherapy (Owen): Entry JAN-1980 to JAN-1987 (381 patients were entered; nonstandard randomisation)

1 Radiotherapy [45Gy in 25 fractions over 5wk]
2 Radiotherapy [40Gy in 15 fractions over 5wk]
3 Radiotherapy [39Gy in 13 fractions over 5wk]

16902 Breast Radiotherapy Fractionation Trial A (Owen and Yarnold): Entry FEB-1986 ff. (earlier description of 3709; not received)

1 Radiotherapy [50Gy in 25 fractions over 5wk]
2 Radiotherapy [39Gy in 13 fractions over 5wk]
3 Radiotherapy [42·9Gy in 13 fractions over 5wk]

16903 80U2 Second Randomisation for Boost Dose to Tumour Bed (Owen and Yarnold): patients with complete histological excision; Entry FEB-1986 ff. (not received)

1 Control
2 Radiotherapy [boost]

16904 Breast Radiotherapy Fractionation Trial B (Owen and Yarnold): Age 18+; Complete Excision (Breast Conservation / Mastectomy); Entry 1994 ff. (earlier description of 3711; not received)

1 Radiotherapy [50Gy in 25 fractions over 5wk]
2 Radiotherapy [40Gy in 15 fractions over 3wk]

170 S.A.S.I.B., Lausanne, Switzerland {Day, Dent, Gudgeon, Hacking, Murray, Stjernsward, Werner: JUN-2000 (UPDATED FIVE TIMES)}

17001 71D SASIB Trial (Groote Schuur, Lausanne, Ljubo...; omitting Göteborg): Stage II; T1-2 N-/N+ M0; Age < 70; Axillary Clearance; Entry APR-1971 to DEC-1977 (377 patients were entered)

1 Control
2 Radiotherapy

171 Daniel den Hoed Cancer Centre, Rotterdam, Netherlands {van Assendelft, Klijn, van Putten, Treurniet-Donker: APR-2001 (THIRD REVISED VERSION)}

17101 77N DUT-LEVAM-RRTI: Stage II; N+; Age < 75; Entry OCT-1977 to MAY-1982 (199 patients were entered)

1 Control
2 Levamisole

17102 85U E²-FAC Trial CKVO 85-09: Age < 66; Stage II-III; T1-3 N+ M0; Modified Mastectomy; Entry OCT-1985 to MAY-1992 (328 patients were entered)

1 Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil
2 Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil + Ethinyloestradiol

172 Coimbra Instituto de Oncologia, Portugal {de Oliveira: AUG-2000 (UPDATED TWICE)}

17201 79F Radiotherapy Trial: Axillary Clearance; N+; Entry OCT-1979 to APR-1983 (124 patients were entered)

1 Doxorubicin + Cyclophosphamide
2 Doxorubicin + Cyclophosphamide + Radiotherapy

17202 83C Neoadjuvant Chemotherapy in Operable Breast Cancer; (T1 N+)/T2/(T3 N0): Entry JAN-1983 to SEP-1989 (213 patients were entered)

1 Surgery
2 (Doxorubicin [45mg/m² iv d1] + Cyclophosphamide [600mg/m² iv d1-28]) × 2 then Surgery

17203 90A Early Breast Cancer: High Risk; Surgery; N+; Entry 1990 ff. (94 patients were entered; not received)

1 (Doxorubicin [45mg/m² iv d1] + Cyclophosphamide [600mg/m² iv d1-28]) × 11
2 Radiotherapy then (Doxorubicin [45mg/m² iv d1] + Cyclophosphamide [600mg/m² iv d1-28]) × 11

173 Heidelberg and Ulm, Germany {Herfarth, Schreml: JUN-1989}

17301 76V Levamisole Trial: N+; Age < 68; Entry JUN-1976 to MAR-1979 (52 patients were entered; synthetic data only; no recurrence information)

1 (Doxorubicin + Cyclophosphamide) × 6
2 (Doxorubicin + Cyclophosphamide) × 6 + Levamisole × 2yr

174 Paris Institut Curie, France {Asselain, Pouillard, Scholl: FEB-1996}

17401 77P Stage II: Entry OCT-1977 to JAN-1980 (242 patients were entered)

1 Cyclophosphamide + Methotrexate + Melphalan
2 Cyclophosphamide + Methotrexate + Melphalan + Bacillus Calmette-Guèrin

17402 81S Radiotherapy Trial: Operable; No Surgery; T2-3 N0-1b; Entry 1981 to 1985 (255 patients were entered; not received)

1 Radiotherapy [55Gy, Co⁶⁰] then Radiotherapy [20Gy in 10 fractions, Co⁶⁰]
2 Radiotherapy [55Gy, Co⁶⁰] then Radiotherapy [20Gy, Ir¹⁹² implant]

17403 83T S5 Trial: Premenopausal/Postmenopausal; Entry 1983 ff. (196 patients were entered; terminated early; not received)

1 (Doxorubicin + Cyclophosphamide) × 2 preoperative then (Doxorubicin + Cyclophosphamide + 5-Fluoro-Uracil) × 4 postoperative
2 (Doxorubicin + Cyclophosphamide + 5-Fluoro-Uracil) × 6 postoperative

17404 86X S6 Trial: Premenopausal; Tumour 3-7cm; N0-16; Entry OCT-1986 to JUN-1990 (414 patients were entered; 24 missing)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil + P) × 4 then Radiotherapy ± Surgery
2 Radiotherapy ± Surgery then (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil + P) × 4

17405 82K S4 Trial: N- clinical; Premenopausal/Postmenopausal; Entry JUL-1982 to AUG-1987 (658 patients were entered; 1 missing)

1 Lumpectomy + Radiotherapy [to breast] + Radiotherapy [to nodes]
2 Lumpectomy + Axillary Dissection + Radiotherapy [to breast]

17406 BCG Trial: not early breast cancer; Entry 1977 ff. (255 patients were entered; not received)

1 V + Doxorubicin + Cyclophosphamide + 5-Fluoro-Uracil
2 V + Doxorubicin + Cyclophosphamide + 5-Fluoro-Uracil + Bacillus Calmette-Guèrin

175 Helsinki Deaconess Medical Centre, Finland {Gröhn, Heinonen, Holsti, Klefström: NOV-2000 (UPDATED TWICE)}

17501 76M Stage II: Age < 70; Entry JUL-1976 to JAN-1978 (72 patients were entered)

1 Radiotherapy postoperative
2 Radiotherapy postoperative + Levamisole

17502 Stage III: Age < 75; mixed allocation types; Entry AUG-1976 to FEB-1979 (60 patients were entered)

1 Radiotherapy + Levamisole
2 V + Doxorubicin + Cyclophosphamide + Levamisole
3 Radiotherapy + V + Doxorubicin + Cyclophosphamide + Levamisole

17503 Stage III: Age < 75 (mixed allocation types); Entry FEB-1978 to DEC-1980 (60 patients were entered)

1 Radiotherapy
2 V + Doxorubicin + Cyclophosphamide
3 Radiotherapy + V + Doxorubicin + Cyclophosphamide

17504 Phase II Study: Postoperative Radiotherapy; Entry ? (not randomised; not received)

1 Electron Beam
2 Tele-Cobalt

17505 82G Kuopio MPA/Bestatin Trial: Stage II; N+; Entry FEB-1982 to AUG-1982 (23 patients were entered)

1 Radiotherapy then (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 6
2 Radiotherapy + Medroxyprogesterone Acetate then (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 6 + Medroxyprogesterone Acetate
3 Radiotherapy + Bestatin + Medroxyprogesterone Acetate then (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 6 + Medroxyprogesterone Acetate then Bestatin
4 Radiotherapy + Bestatin then (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 6 then Bestatin

176 Italian Coöperative Chemo-Radio-Surgical Group, Bologna {Pannuti: MAR-1990}

17601 75S Bologna: N+; Entry JUN-1975 to JUL-1985 (288 patients were entered)

1 Radiotherapy
2 Medroxyprogesterone Acetate [high dose]

17602 79L1 Bologna: Premenopausal; Entry APR-1979 to NOV-1985 (151 patients were entered)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Medroxyprogesterone Acetate

17603 79L2 Bologna: Postmenopausal; Entry MAR-1979 to JUL-1985 (138 patients were entered)

1 Medroxyprogesterone Acetate
2 Control

177 Belgian Adjuvant Breast Cancer Project, Liège {Focan, Lobelle: MAR-1996 (UPDATED)}

17701 81M1 MPA Trial: N-; Entry OCT-1981 to AUG-1989 (260 patients were entered)

1 Control
2 Medroxyprogesterone Acetate [high dose]

17702 81M2 MPA Trial: N+; Age < 70; Entry FEB-1982 to MAY-1989 (292 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 + Medroxyprogesterone Acetate [high dose]

17703 89H MPA and Tamoxifen Trial: Low Risk; Entry 1989/1990 ff. (about 100 patients were entered; not received)

1 Medroxyprogesterone Acetate [high dose]
2 Tamoxifen

17704 MPA Trial: High Risk; Premenopausal; Entry 1989/1990 ff. (not activated; not received)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil then Medroxyprogesterone Acetate
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

178 Instituto Policlinico, Barcelona, Spain {Millá Santos, Sanchiz: MAY-1990 (UPDATED)}

17801 (Millá Santos): N+; Entry FEB-1984 to DEC-1984 (102 patients were entered; nonstandard randomisation)

1 Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12
2 Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12 + AM3

17802 (Sanchiz): N+; Entry JAN-1982 to JUN-1985 (702 patients were entered; nonstandard randomisation)

1 Radiotherapy
2 Radiotherapy + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12

17803 88G (Millá Santos): Infiltrating Ductal Carcinoma; High Risk; N-; ER-; Tumour > 3cm; Entry JAN-1988 to JAN-1998 (584 patients were entered; not received)

1 (Cyclophosphamide [600mg/m² d1] + Methotrexate [60mg/m² d1] + 5-Fluoro-Uracil [750mg/m² d1]) q21d × 8
2 Control

17804 (Millá Santos): Phase II; Advance Cancer; Postmenopausal; ER+; Entry MAY-1997 ff. (238 patients were entered; not received)

1 Anastrozole [1mg/d po] × 1yr
2 Tamoxifen [40mg/d po] × 1yr

179 Würzburg University, Germany {Caffier: SEP-1990 (UPDATED)}

17901 76U1 Trial 1 (A1): T1-2 N-; Age < 66; Entry JAN-1977 to MAR-1980 (203 patients were entered)

1 Radiotherapy
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 12

17902 76U2 Trial 3 (B): N+; Age < 66; Entry DEC-1976 to JUN-1983 (270 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil then Radiotherapy) × 2
2 (Radiotherapy then Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 2

17903 76U3 Tamoxifen Trial: Postmenopausal; N-; Age 61+; Entry 1980 ff. (173 patients were entered; nonstandard randomisation; synthetic data only; no recurrence information)

1 Radiotherapy
2 Radiotherapy + Tamoxifen [20mg/d] × 1yr

17904 76U4 Trial 2 (A2): T1-2 N-; Age < 61; Entry APR-1980 to MAY-1982 (97 patients were entered)

1 Radiotherapy
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6

180 Heidelberg University, Germany {von Fournier: SEP-1991}

18001 79N1 GER-UFH-BR-79: N+; Age < 60; Entry 1979 to 1982 (145 patients were entered into 18001-18002; not received)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Azimexon

18002 79N2 Azimexon Trial: N-; Age < 50; Entry 1979 to 1982 (145 patients were entered into 18001-18002; not received)

1 Control
2 Azimexon

18003 Wide Excision: N+ M0; Entry 1978 ff. (200 patients were entered; synthetic data only; no recurrence information; possibly subset of 5804)

1 Radiotherapy + (Chlorambucil + 5-Fluoro-Uracil) × 6m
2 Radiotherapy

181 Bradford Royal Infirmary, U.K. {Hancock, Masood, Parker, Price: MAY-1995 (UPDATED THRICE)}

18101 74J1 Stage I or II: Postmenopausal; Age < 65; Entry JUL-1974 to APR-1985 (81 patients were entered)

1 Radiotherapy [selective]
2 (Methotrexate + Triethylenephosphoramide) × 3

18102 74J2 Stage I or II: Premenopausal; Age < 65; Entry SEP-1974 to JUL-1985 (94 patients were entered)

1 Radiotherapy [selective]
2 (Methotrexate + Triethylenephosphoramide) × 3
3 Radiotherapy [selective] + Oöphorectomy
4 Oöphorectomy + (Methotrexate + Triethylenephosphoramide) × 3

18103 74J3 Positive Bone/Liver/Lung: Postmenopausal; Age < 65; Entry OCT-1974 to OCT-1981 (16 patients were entered)

1 Radiotherapy [selective]
2 (Methotrexate + Triethylenephosphoramide) × 3

18104 74J4 Positive Bone/Liver/Lung: Premenopausal; Age < 65; Entry NOV-1975 to FEB-1984 (12 patients were entered)

1 Radiotherapy [selective]
2 (Methotrexate + Triethylenephosphoramide) × 3
3 Radiotherapy [selective] + Oöphorectomy
4 Oöphorectomy + (Methotrexate + Triethylenephosphoramide) × 3

182 Louvain Academisch Ziekenhuis St Rafael, Belgium {Bonte: FEB-1990}

18201 79Q1 Louvain: N+; Postmenopausal; Entry ? (not received)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 Tamoxifen [20-40mg/d] × 1yr
3 Medroxyprogesterone Acetate × 1yr

18202 79Q2 GG-CMF-TAM-MPA: N+; Entry MAR-1979 to FEB-1983 (111 patients were entered; an additional 3 possibly missing)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 (Tamoxifen + Medroxyprogesterone Acetate) × 1yr / Tamoxifen/Medroxyprogesterone Acetate × 1yr /

183 Central Pennsylvania Oncology Group, U.S.A. {Lipton: JUN-1989}

18301 74H1 CPOG: N+; Age < 75; Entry OCT-1974 ff. (91 patients were entered; synthetic data only; no recurrence information)

1 Melphalan
2 Melphalan + 5-Fluoro-Uracil + Prednisone + Chlorambucil + Methotrexate

18302 74H2 CPOG: Stage II; N+; Entry ? (52 patients were entered; not received)

1 Melphalan
2 Cyclophosphamide + Doxorubicin/Methotrexate + 5-Fluoro-Uracil

184 Richmond Medical College of Virginia, U.S.A. {Schulz: JUN-1989}

18401 Virginia: Premenopausal/Postmenopausal; 15 different dose ratios; Entry ? (100 patients were entered; not received)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) [dose ratios 1-7]
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) [dose ratios 8-15]

185 Hopital Privado Guemes, Buenos Aires, Argentina {Cavarra, Loza: JUN-1989}

18501 Loza: Stage I-II; N+; Entry JUL-1979 to JUL-1981 (about 110 patients were entered; not randomised; not received)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Doxorubicin + V

18502 Cavarra: Stage II; Entry 1982 to 1989 (about 190 patients were entered; not randomised; not received)

1 (Doxorubicin + Cyclophosphamide) × 4
2 (Doxorubicin + Cyclophosphamide) × 8

186 Düsseldorf University, Germany {Faber, Trampisch: APR-1990}

18601 78Q1 Düsseldorf: N1-3; ER-; PR-; Entry MAR-1977 to OCT-1981 (134 patients were entered)

1 Melphalan × 6
2 (Chlorambucil + Methotrexate + 5-Fluoro-Uracil) × 6

18602 78Q2 Düsseldorf: N4+; ER-; PR-; Entry APR-1977 to OCT-1981 (88 patients were entered)

1 (Chlorambucil + Methotrexate + 5-Fluoro-Uracil) × 12
2 ((Chlorambucil + Methotrexate + 5-Fluoro-Uracil) × 3 then Radiotherapy [40Gy]) × 2 then (Chlorambucil + Methotrexate + 5-Fluoro-Uracil) × 6

187 Philadelphia Fox Chase Cancer Center, U.S.A. {Creech, Solin: JUL-1990}

18701 74P1 AOH 74-120, Alkeran Versus Low Dose CMF as Adjuvant Therapy for Breast Cancer Patients With Positive Axillary Nodes (Creech): Premenopausal/Postmenopausal; N+; Entry AUG-1974 to SEP-1984 (351 patients were entered)

1 Melphalan × 2yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 1yr

18702 86U (Solin): N-; Breast Conservation Surgery; Age 25-70; Entry 1986 ff. (20 patients were entered; terminated early; not received)

1 Radiotherapy
2 Radiotherapy + Electron Beam

18703 74P2 CMF-Refractory (Creech): Entry ? (not received)

1 Doxorubicin [low dose]
2 Mitomycin-C [low dose]

188 Wisconsin University, U.S.A. {DeMets, Love: SEP-2000 (SECOND REVISED VERSION)}

18801 86K Wisconsin Tamoxifen Study: Stage I; Postmenopausal; Age < 65; N-; Entry NOV-1986 to SEP-1988 (140 patients were entered)

1 Tamoxifen [20mg/d] × 2yr
2 Control

18802 93G NCI Hanoi 9201: Operable; Stage II-IIIa; Premenopausal; Entry 1993 ff. (262 patients were entered by 1-APR-1995; not received)

1 Oöphorectomy + Tamoxifen × 5yr
2 Control

189 New England Deaconess Hospital, Boston, U.S.A. {Lokich: JUL-1989}

18901 'Aborted' Trial: Entry ? (not received)

1 Unknown
2 Unknown

190 Glasgow Royal Infirmary, Scotland {Anderson, McArdle: JUL-1989}

19001 'Lost' Trial: Entry ? (?<10 patients were entered; not received)

1 Unknown
2 Unknown

191 Auckland Breast Cancer Study Group, New Zealand {Kay: JUN-2000 (UPDATED TWICE)}

19101 76T Levamisole Trial: Age < 65; N+; Entry OCT-1976 to OCT-1980 (135 patients were entered)

1 Melphalan + Levamisole
2 Melphalan

192 Cologne, Germany {Reusch-Kusche, Zippel: JUN-1989}

19201 76L1 Relatively Small Lymph Node Involvement: N+; Entry 1976 to 1980 (61 patients were entered; not received)

1 Doxorubicin + Cyclophosphamide
2 Control

19202 76L2 High Risk: Axillary Clearance; N+; Entry 1976 to 1980 (95 patients were entered; not received)

1 Doxorubicin + Cyclophosphamide
2 Doxorubicin + Cyclophosphamide + Radiotherapy [megavoltage]

193 Athens Metaxas Memorial Cancer Hospital, Greece {Foroglou, Giokas, Kondylis, Lissaios: SEP-2000 (REVISED VERSION)}

19301 79G1 Pericles A Stage II: Premenopausal/Postmenopausal; Entry JAN-1979 to SEP-1982 (90 patients were entered)

1 (Methotrexate + 5-Fluoro-Uracil + Doxorubicin) preoperative + (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Doxorubicin) × 5 postoperative
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Doxorubicin) × 6 postoperative

19302 79G2 Pericles A Stage III: Premenopausal; Entry FEB-1979 to OCT-1982 (30 patients were entered)

1 Chemotherapy × 2 preoperative + Oöphorectomy + Radiotherapy [50-60Gy] + Chemotherapy × 10 postoperative
2 Chemotherapy × 2 preoperative + Oöphorectomy + Chemotherapy × 10 postoperative

19303 79G3 Pericles A Stage III: Postmenopausal; Entry JAN-1979 to NOV-1982 (41 patients were entered)

1 Chemotherapy × 2 preoperative + Radiotherapy [50-60Gy] + Antioestrogen + Chemotherapy × 10 postoperative
2 Chemotherapy × 2 preoperative + Antioestrogen + Chemotherapy × 10 postoperative

19304 82Z1 Metaneira B Stage II and III: Premenopausal; N-; Entry APR-1983 to SEP-1984 (17 patients were entered)

1 Oöphorectomy + (V + Doxorubicin + Cyclophosphamide) × 3
2 Oöphorectomy + (V + Doxorubicin + Cyclophosphamide) × 1

19305 82Z2 Metaneira B Stage II and III: Premenopausal; N+; Entry JAN-1983 to DEC-1984 (30 patients were entered)

1 Oöphorectomy + (V + Doxorubicin + Cyclophosphamide) × 3 + (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 7
2 Oöphorectomy + (V + Doxorubicin + Cyclophosphamide) × 3

19306 82Z3 Metaneira B Stage II and III: Postmenopausal; N-; Entry DEC-1982 to DEC-1984 (44 patients were entered)

1 (V + Doxorubicin + Cyclophosphamide) × 3
2 (V + Doxorubicin + Cyclophosphamide) × 1

19307 82Z4 Metaneira B Stage II and III: Postmenopausal; N+; Entry JAN-1983 to DEC-1984 (44 patients were entered)

1 (V + Doxorubicin + Cyclophosphamide) × 3 + (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 7
2 (V + Doxorubicin + Cyclophosphamide) × 3

19308 82Z5 Pileas C Stage II and III: Premenopausal; N-; Entry MAR-1985 to NOV-1990 (51 patients were entered)

1 Oöphorectomy + (V + Doxorubicin + Cyclophosphamide) × 3 + Tamoxifen [30mg/d] × up to 5y
2 Oöphorectomy + (V + Doxorubicin + Cyclophosphamide) × 1 + Tamoxifen [30mg/d] × up to 5y

19309 82Z6 Pileas C Stage II and III: Premenopausal; N+; Entry FEB-1985 to NOV-1990 (74 patients were entered)

1 Oöphorectomy + (V + Doxorubicin + Cyclophosphamide) × 3 + (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 7 + Tamoxifen [30mg/d] × up to 5y
2 Oöphorectomy + (V + Doxorubicin + Cyclophosphamide) × 3 + Tamoxifen [30mg/d] × up to 5y

19310 82Z7 Pileas C Stage II and III: Postmenopausal; N-; Entry JAN-1985 to DEC-1990 (136 patients were entered)

1 (V + Doxorubicin + Cyclophosphamide) × 3 + Tamoxifen [30mg/d] × up to 5y
2 (V + Doxorubicin + Cyclophosphamide) × 1 + Tamoxifen [30mg/d] × up to 5y

19311 82Z8 Pileas C Stage II and III: Postmenopausal; N+; Entry JAN-1985 to DEC-1990 (160 patients were entered)

1 (V + Doxorubicin + Cyclophosphamide) × 3 + (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 7 + Tamoxifen [30mg/d] × up to 5y
2 (V + Doxorubicin + Cyclophosphamide) × 3 + Tamoxifen [30mg/d] × up to 5y

195 Illinois, U.S.A. {Briele: JUN-1989}

19501 Nitrogen Mustard Trial: Age < 70; Entry APR-1956 to 1964 (156 patients were entered; synthetic data only; no recurrence information; nonstandard randomisation; 'on ice')

1 Control
2 Nitrogen Mustard

196 Newcastle General Hospital, U.K. {Finney: JUN-1989}

19601 67D Perioperative Cyclophosphamide Trial: Stage I-II; Age < 70; Entry ? (83 patients were entered; synthetic data only; no recurrence information)

1 Radiotherapy postoperative + Cyclophosphamide perioperative
2 Radiotherapy postoperative

197 Paris, France {Espié, Marty: JUL-1996}

19701 79H G.E.M.M.: Premenopausal; N-; Entry SEP-1979 to APR-1991 (335 patients were entered)

1 Control
2 (Cyclophosphamide [400mg/m² d1,8] + Methotrexate [40mg/m² d1,8] + 5-Fluoro-Uracil [400mg/m² d1,8]) q1m × 6

19702 G.E.M.M.: Premenopausal; N+; Entry ? (not received; alternate description of 20001,20003)

1 5-Fluoro-Uracil + 4-Epi-Doxorubicin + Cyclophosphamide
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

198 University of the Witwatersrand, Johannesburg, Republic of South Africa {Bezwoda, Derman: DEC-1995 (UPDATED FOUR TIMES)}

19801 77T1 Stage III (surgery subset): Entry AUG-1980 to FEB-1981 (8 patients were entered)

1 Radiotherapy perioperative + (Cyclophosphamide [600mg/m² iv] + Methotrexate [40mg/m² iv] + 5-Fluoro-Uracil [600mg/m² iv]) × 12
2 Radiotherapy perioperative + (Cyclophosphamide [350mg/m² iv] + Methotrexate [35mg/m² iv] + 5-Fluoro-Uracil [350mg/m² iv]) × 12

19802 77T2 Stage III (surgery subset): 1:1 Randomisation; Entry FEB-1981 to DEC-1983 (19 patients were entered)

1 Radiotherapy perioperative
2 Radiotherapy perioperative + (Cyclophosphamide [350mg/m² iv] + Methotrexate [35mg/m² iv] + 5-Fluoro-Uracil [350mg/m² iv]) × 12

19803 Stage II: Entry ? to 1996 (not received)

1 Unknown
2 Unknown

19804 Stage III (non-operated subset): Entry JAN-1978 to JUN-1981 (77 patients were entered)

1 Radiotherapy + (Cyclophosphamide [600mg/m² iv] + Methotrexate [60mg/m² iv] + 5-Fluoro-Uracil [600mg/m² iv]) × 12
2 Radiotherapy + (Cyclophosphamide [350mg/m² iv] + Methotrexate [35mg/m² iv] + 5-Fluoro-Uracil [350mg/m² iv]) × 12

19805 Stage III (non-operated subset): Entry OCT-1981 to SEP-1986 (109 patients were entered)

1 Radiotherapy
2 Radiotherapy + (Cyclophosphamide [350mg/m² iv] + Methotrexate [35mg/m² iv] + 5-Fluoro-Uracil [350mg/m² iv]) × 12

19806 77T4 Stage III (surgery subset): 2:1 Randomisation; Entry FEB-1984 to JUL-1985 (21 patients were entered)

1 Radiotherapy perioperative
2 Radiotherapy perioperative + (Cyclophosphamide [350mg/m² iv] + Methotrexate [35mg/m² iv] + 5-Fluoro-Uracil [350mg/m² iv]) × 12

200 International Collaborative Cancer Group, Charing Cross Hospital, London, U.K. {Bliss, Chilvers, Coombes, Meyer: SEP-2001 (REVISED VERSION, UPDATED)}

20001 84L1 Premenopausal: N+; Entry FEB-1984 to APR-1992 (759 patients were entered; contains 19702)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) × 6/8

20002 88F Postmenopausal: N+; Entry APR-1988 to FEB-1995 (604 patients were entered)

1 4-Epi-Doxorubicin [50mg/m² d1,8] q4wk × 6 + Tamoxifen [20mg/d] × 4yr
2 Tamoxifen [20mg/d] × 4yr

20003 84L2 C/6/89: Poor Risk; Premenopausal; N-; Entry 1990 to JUL-2000 (950 patients were entered; not received; contains 19702)

1 (Cyclophosphamide [600mg/m² d1,8] + Methotrexate [40mg/m² d1,8] + 5-Fluoro-Uracil [600mg/m² d1,8]) q4wk × 6
2 (Cyclophosphamide [600mg/m² d1,8] + 4-Epi-Doxorubicin [50mg/m² d1] + 5-Fluoro-Uracil [600mg/m² d1,8]) q4wk × 6

20004 93T High Dose Therapy with PBSC Support in Primary Breast Cancer C/10/92: N4+; Age < 61; Entry JUL-1993 ff. (262 patients were entered by FEB-2000, target 300; not received)

1 (Cyclophosphamide [600mg/m² d1] + 4-Epi-Doxorubicin [50mg/m² d1] + 5-Fluoro-Uracil [600mg/m² d1] + GM-Colony Stimulating Factor [d2-11]) then (Cyclophosphamide [600mg/m² d1] + 4-Epi-Doxorubicin [50mg/m² d1] + 5-Fluoro-Uracil [600mg/m² d1,8]) q4wk × 2 then (Cyclophosphamide [6g/m²] + Triethylenephosphoramide [500mg/m²] + Carboplatin [800mg/m²]) continuous over 4d then Autologous Stem Cell Transplant then Radiotherapy + Tamoxifen × 5yr
2 (Cyclophosphamide [600mg/m² d1] + 4-Epi-Doxorubicin [50mg/m² d1] + 5-Fluoro-Uracil [600mg/m² d1]) q3wk × 1 then (Cyclophosphamide [600mg/m² d1] + 4-Epi-Doxorubicin [50mg/m² d1] + 5-Fluoro-Uracil [600mg/m² d1,8]) q4wk × 5 then Radiotherapy + Tamoxifen × 5yr

20005 96K Chemotherapy Trial: N6+; Stage II; Entry 1996 ff. (not received)

1 Cyclophosphamide + Triethylenephosphoramide + Carboplatin
2 Cyclophosphamide + 4-Epi-Doxorubicin

20006 91F1 C/9/91 (Coombes, Marty): Premenopausal; N1-5; Entry SEP-1991 to JUL-2000 (784 patients were entered to 20006-20007; not received)

1 (Cyclophosphamide [600mg/m² d1] + 4-Epi-Doxorubicin [50mg/m² d1] + 5-Fluoro-Uracil [600mg/m² d1]) q3wk × 8
2 (Cyclophosphamide [600mg/m² d1] + 4-Epi-Doxorubicin [75mg/m² d1] + 5-Fluoro-Uracil [600mg/m² d1]) q3wk × 8
3 (Cyclophosphamide [600mg/m² d1] + 4-Epi-Doxorubicin [50mg/m² d1] + 5-Fluoro-Uracil [600mg/m² d1]) q3wk × 8 + Tamoxifen × 5yr
4 (Cyclophosphamide [600mg/m² d1] + 4-Epi-Doxorubicin [75mg/m² d1] + 5-Fluoro-Uracil [600mg/m² d1]) q3wk × 8 + Tamoxifen × 5yr

20007 91F2 C/9/91 (Coombes, Marty): "Not Premenopausal"; N1-5; Entry SEP-1991 to JUL-2000 (784 patients were entered to 20006-20007; not received)

1 (Cyclophosphamide [600mg/m² d1] + 4-Epi-Doxorubicin [50mg/m² d1] + 5-Fluoro-Uracil [600mg/m² d1]) q3wk × 8
2 (Cyclophosphamide [600mg/m² d1] + 4-Epi-Doxorubicin [75mg/m² d1] + 5-Fluoro-Uracil [600mg/m² d1]) q3wk × 8
3 (Cyclophosphamide [600mg/m² d1] + 4-Epi-Doxorubicin [50mg/m² d1] + 5-Fluoro-Uracil [600mg/m² d1]) q3wk × 8 + GnRH Agonist × 3yr
4 (Cyclophosphamide [600mg/m² d1] + 4-Epi-Doxorubicin [75mg/m² d1] + 5-Fluoro-Uracil [600mg/m² d1]) q3wk × 8 + GnRH Agonist × 3yr

20008 97A1 Multicentre Randomised Trial of Sequential Epirubicin and Docetaxel versus Epirubicin in Node Positive Postmenopausal Breast Cancer Patients C/14/96 (Erdkamp, Hupperets, Marty): N+; Postmenopausal; 2-Way; Entry 1997 ff. (125 patients were entered into 20008-20009 by MAR-2000, target 800; not received)

1 4-Epi-Doxorubicin [50mg/m² d1,8] q4wk × 6 + Tamoxifen × 5yr concurrent
2 (4-Epi-Doxorubicin [50mg/m² d1,8] q4wk × 3 then Docetaxel [100mg/m² d1] q3wk × 3) + Tamoxifen × 5yr concurrent

20009 97A2 Multicentre Randomised Trial of Sequential Epirubicin and Docetaxel versus Epirubicin in Node Positive Postmenopausal Breast Cancer Patients C/14/96 (Erdkamp, Hupperets, Marty): N+; Postmenopausal; 4-Way; Entry 1997 ff. (125 patients were entered into 20008-20009 by MAR-2000, target 800; not received)

1 4-Epi-Doxorubicin [50mg/m² d1,8] q4wk × 6 + Tamoxifen × 5yr concurrent
2 (4-Epi-Doxorubicin [50mg/m² d1,8] q4wk × 3 then Docetaxel [100mg/m² d1] q3wk × 3) + Tamoxifen × 5yr concurrent
3 4-Epi-Doxorubicin [50mg/m² d1,8] q4wk × 6 then Tamoxifen × 5yr
4 (4-Epi-Doxorubicin [50mg/m² d1,8] q4wk × 3 then Docetaxel [100mg/m² d1] q3wk × 3) then Tamoxifen × 5yr

20010 98C Inter-Group Exemestane Study 960EXE031 (BIG 02/97) C/13/96: Postmemnopausal; Entry 1998 ff. (not received)

1 Tamoxifen × 5yr
2 Tamoxifen × 2-3yr then Exemestane × 3-2yr

201 Russian Academy of Medical Sciences, Moscow, Russia {Garin, Karev, Portnoj: DEC-1995 (REVISED VERSION)}

20101 Radical Mastectomy (Garin): Entry 1969 to 1970 (694 patients were entered; nonstandard randomisation; not received)

1 Control
2 Radiotherapy
3 Triethylenephosphoramide perioperative
4 Cyclophosphamide perioperative

20102 89J1 CRCRAMS Study (Portnoj): T1-2 N0 M0; Premenopausal; Entry OCT-1989 to AUG-1992 (28 patients were entered)

1 (Cyclophosphamide [550mg/m² iv d1,8] + Methotrexate [25mg/m² iv d1,8] + 5-Fluoro-Uracil [500mg/m² iv d1,8]) q3-4wk × 6
2 Triethylenephosphoramide [20mg 3/wk to 80mg im] q2·5-3m × 4
3 Control

20103 89J2 CRCRAMS Study (Portnoj): T1-2 N0 M0; Postmenopausal; ER+/ER? / PR+/PR?; Entry NOV-1989 to FEB-1993 (21 patients were entered)

1 Control
2 Triethylenephosphoramide [20mg 3/wk to 80mg im] q2·5-3m × 4
3 Tamoxifen [20mg/d] × 2yr
4 Triethylenephosphoramide [20mg 3/wk to 80mg im] q2·5-3m × 4 + Tamoxifen [20mg/d] × 2yr

20104 89J3 CRCRAMS Study (Portnoj): T1-2 N0 M0; Postmenopausal; ER-; PR-; Entry FEB-1990 to MAR-1991 (4 patients were entered)

1 Control
2 Triethylenephosphoramide [20mg 3/wk to 80mg im] q2·5-3m × 4

20105 CRCRAMS Study (Portnoj): (T1-2 N2)/(T3 N1); Entry 1991 ff. (not randomised; not received)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) [iv] × 2
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) [lymphatically] × 2 + Tumour Cells
3 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) [lymphatically] × 2

202 Tunis Institut Salah Azaiz, Tunisia {Bahi, Ben Moussa, Levine, Mourali, Muenz, Tabbane: MAY-1990}

20201 77U ISA1: Entry APR-1977 to NOV-1979 (91 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 then Surgery then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 15
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 then Radiotherapy then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 15

203 Chinese Academy of Medical Sciences, Beijing, China {Dr Y. Sun: JUN-1989}

20301 Traditional Chinese Medicine Trial: Entry ? (not randomised; not received)

1 Radiotherapy + Traditional Chinese Medicine
2 Radiotherapy

204 Harvard Medical School, Boston, U.S.A. {Harris, Platt: MAY-1994}

20401 Surgery: Entry ? (non-trial, probably part of 66...; not received)

1 Radical Mastectomy
2 Conservation Surgery + Radiotherapy

20402 Antibiotic Prophylaxis Trial: Patients Undergoing Herniorraphy or Breast Surgery; Infection Endpoint; Entry ? (not received)

1 Cefonicid [1g] preoperative
2 Control

206 Paris Centre René Huguenin, St-Cloud, France {Rambert, Tubiana-Hulin: SEP-1995 (UPDATED THRICE)}

20601 74M F.C.L.C.C. Chirurgie Radicale Versus Radiothérapie Exclusive: Age 35-70; Entry FEB-1974 to JUN-1977 (166 patients were entered; terminated early)

1 Radiotherapy
2 Mastectomy + Axillary Clearance

20602 Chemotherapy Trial: Entry post-1990 (<40 patients were entered; not received)

1 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 4 preoperative then (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 2 postoperative
2 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 6 postoperative

207 Prague Charles University, Czech Republic {Andrysek, Barkmanová, Friedmannová: MAY-1990}

20701 76X CZE-CHECO-1 (Phase III Adjuvant Immunotherapy with BCG): N-; Age 18-70; Entry NOV-1976 to OCT-1979 (20 patients were entered)

1 Control
2 Bacillus Calmette-Guèrin

208 Etela-Saimaa Central Hospital, Lappeenranta, Finland {Tiusanen: JUL-1989}

20801 Radiotherapy, Chemotherapy and Tamoxifen Trial (duplicated as 23301): N+; Entry ? (not received)

1 Radiotherapy
2 Chemotherapy
3 Radiotherapy + Chemotherapy
4 Radiotherapy + Chemotherapy + Tamoxifen

209 Cracow Institute of Oncology, Poland {Chrzanowska, Korzeniowski, Sko£yszewski: JUL-1996 (REVISED VERSION, UPDATED)}

20901 61D UICC68-83: Halsted Mastectomy; T3 N0-1; Entry AUG-1961 to JAN-1974 (164 patients were entered)

1 Radiotherapy preoperative
2 Radiotherapy postoperative

210 Los Angeles University of California, U.S.A. {Giuliano, Sparks: AUG-1989}

21001 74L1 Adjuvant Chemo-Immunotherapy in Stage II Carcinoma of the Breast (3-Way): N+; Entry JUL-1974 to OCT-1974 (130 patients were entered; not received)

1 Control
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Bacillus Calmette-Guèrin
3 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Bacillus Calmette-Guèrin + Tumour Cell Vaccine

21002 74L2 Adjuvant Chemo-Immunotherapy in Stage II Carcinoma of the Breast (2-Way): N+; Entry NOV-1974 ff. (not received)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Bacillus Calmette-Guèrin
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Bacillus Calmette-Guèrin + Tumour Cell Vaccine

21003 74L3 Adjuvant Chemo-Immunotherapy in Stage II Carcinoma of the Breast (3-Way): N+; Entry ? (not received)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Bacillus Calmette-Guèrin
3 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Bacillus Calmette-Guèrin + Tumour Cell Vaccine

21004 74L4 Adjuvant Chemo-Immunotherapy in Stage II Carcinoma of the Breast (2-Way): N+; Entry ? to JUL-1978 (not received)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Bacillus Calmette-Guèrin

21005 Post-Surgery Rehabilitation: Patients Newly Diagnosed with Breast Cancer; Stage I-II; Psychological Endpoint; Entry MAY-1987 to DEC-1988 (not received)

1 Experimental Case-Management Intervention
2 Control

211 Lodz, Poland {Jeziorski: OCT-1989}

21101 90D Axillary Dissection: Entry 1990 ff. (not received)

1 Tumorectomy + Radiotherapy
2 Quadrantectomy + Radiotherapy

21102 96L OCSGL Trial: N10+; Entry 1996 ff. (2 patients were entered by 1997; not received)

1 (5-Fluoro-Uracil [500mg/m² iv] + 4-Epi-Doxorubicin [50mg/m² iv] + Cyclophosphamide [500mg/m² iv]) q21d × 6 then Tamoxifen × 3yr
2 (Cyclophosphamide [75mg/m² po d1-4] + 4-Epi-Doxorubicin [60mg/m² iv d1,8] + 5-Fluoro-Uracil [500mg/m² iv d1,8]) q28d × 6 then Tamoxifen × 3yr
3 ((4-Epi-Doxorubicin [120mg/m² iv] + Cyclophosphamide [830mg/m² iv]) q14d + G-Colony Stimulating Factor [5µg/kg d5-10]) × 6 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 then Tamoxifen × 3yr

212 Napoli Istituto Tumori, Italy {D'Aiuto: SEP-1989}

21201 77R1 Surgery and Radiotherapy Trial: Age < 71; N0-1; Premenopausal/Postmenopausal; Entry 1977 to 1987 (340 patients were entered; synthetic data only; no recurrence information)

1 Modified Radical Mastectomy
2 Quadrantectomy + Full Axillary Dissection then Radiotherapy

21202 77R2 Surgery and Radiotherapy Trial: Entry 1985 to 1988 (342 patients were entered; not received)

1 Quadrantectomy + Full Axillary Dissection then Radiotherapy
2 Tumorectomy + Axillary Dissection

214 Bilbao Hospital de Cruces, Spain {Gimeno Alfós: SEP-1989}

21401 87J Toxicity Study: Patey Mastectomy; Stage IIa-IIIa; Entry 1987 ff. (35 patients were entered; not received)

1 Radiotherapy + (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6
2 Radiotherapy + (Cyclophosphamide + Mitozantrone + 5-Fluoro-Uracil) × 6

215 Tel Aviv University, Israel {Hercbergs: SEP-1989}

21501 84M Post-Mastectomy Therapy to Prevent Spinal Metastasis: Entry 1984 ff. (242 patients were entered; not received)

1 Radiotherapy
2 Electron Beam

216 Uppsala-Örebro Cancer Study Group, Sweden {Bergh, Holmberg, Liljegren, Nilsson, Rudenstam, Rydén, Wallgren: SEP-2000 (REVISED VERSION)}

21601 81L Sector Resection: Unifocal Tumour; Stage I; N- (dissection); Entry SEP-1981 to AUG-1988 (389 patients were entered; 8 exclusions missing)

1 Radiotherapy [megavoltage]
2 Control

21602 Second Study of Sector Resection; part of Swedish Multi-Centre Study: Unifocal Tumour; N- dissection; Entry JUL-1991 to FEB-1992 (35 patients were entered; not received; terminated early; part of 4405)

1 Radiotherapy [54Gy megavoltage in 27 fractions to chest wall/breast over 5wk]
2 Control

21603 94K Scandinavian Multi-Centre Study SBG9401 (Bergh): High Risk; (N8+ axilla)/(N5+, ER-, High S-Phase); Entry FEB-1994 to FEB-1998 (525 patients were entered)

1 (Cyclophosphamide [450-1800mg/m²] + 4-Epi-Doxorubicin [38-120mg/m²] + 5-Fluoro-Uracil [300-600mg/m²]) × 9 + G-Colony Stimulating Factor + Ciprofloxacin + Radiotherapy [locoregional] + Tamoxifen × 5yr
2 (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) × 2 then (Cyclophosphamide [1200mg/m²] + 4-Epi-Doxorubicin [60mg/m²] + 5-Fluoro-Uracil [600mg/m²]) × 1 then (Cyclophosphamide [6g/m²] + Triethylenephosphoramide [500mg/m²] + Carboplatin [800mg/m²]) + Peripheral Stem Cell Transplantation + Radiotherapy [locoregional] + Tamoxifen × 5yr

21604 Swedish Multi-Centre Study (Holmberg, Möller, Rudenstam, Rydén, Wallgren): Sector Resection; Unifocal Tumour; Entry 1991 to 1998 (duplicated as 4405; not received)

1 Radiotherapy
2 Control

21605 89U3 CSBII:2 (Uppsala-Örebro part of DBCG89b-Umeå-Uppsala-Örebro Trial) (Bergh): Premenopausal; ER+; N+; Entry JAN-1990 to JAN-1998 (153 patients were entered)

1 (Cyclophosphamide [600mg/m² iv] + Methotrexate [40mg/m² iv] + 5-Fluoro-Uracil [600mg/m² iv]) q3wk × 9
2 Ovarian Irradiation [3Gy × 5 in 1wk]

21606 89Wb Uppsala-Örebro part of DBCG89d-Umeå-Uppsala-Örebro Trial, 4-Way (Bergh): Premenopausal; ER-; N+; Entry FEB-1990 to JAN-1996 (101 patients were entered)

1 (Cyclophosphamide [600mg/m² iv] + Methotrexate [40mg/m² iv] + 5-Fluoro-Uracil [600mg/m² iv]) q3wk × 9
2 (Cyclophosphamide [600mg/m² iv] + 4-Epi-Doxorubicin [60mg/m² iv] + 5-Fluoro-Uracil [600mg/m²]) q3wk × 9
3 (Cyclophosphamide [600mg/m² iv] + Methotrexate [40mg/m² iv] + 5-Fluoro-Uracil [600mg/m² iv]) q3wk × 9 + Pamidronate [150mg × 2 po] × 4yr
4 (Cyclophosphamide [600mg/m² iv] + 4-Epi-Doxorubicin [60mg/m² iv] + 5-Fluoro-Uracil [600mg/m²]) q3wk × 9 + Pamidronate [150mg × 2 po] × 4yr

21607 89Wc Uppsala-Örebro part of DBCG89d-Umeå-Uppsala-Örebro Trial, 2-Way (Bergh): Premenopausal; ER-; N+; Entry JUN-1996 to OCT-1997 (11 patients were entered)

1 (Cyclophosphamide [600mg/m² iv] + Methotrexate [40mg/m² iv] + 5-Fluoro-Uracil [600mg/m² iv]) q3wk × 9
2 (Cyclophosphamide [600mg/m² iv] + 4-Epi-Doxorubicin [60mg/m² iv] + 5-Fluoro-Uracil [600mg/m²]) q3wk × 9

21608 79T6 Uppsala-Örebro part of SESBCG-Örebro-Karlstad Study (Bergh): Postmenopausal; Entry DEC-1990 to DEC-1994 (536 patients were entered)

1 Tamoxifen × 2yr
2 Tamoxifen × 5yr

21609 89Wd Uppsala-Örebro part of DBCG89d-Umeå-Uppsala-Örebro Trial, 4-Way (Bergh): Postmenopausal; ER-; N+; Entry SEP-1993 to JAN-1996 (20 patients were entered)

1 (Cyclophosphamide [600mg/m² iv] + Methotrexate [40mg/m² iv] + 5-Fluoro-Uracil [600mg/m² iv]) q3wk × 9
2 (Cyclophosphamide [600mg/m² iv] + 4-Epi-Doxorubicin [60mg/m² iv] + 5-Fluoro-Uracil [600mg/m²]) q3wk × 9
3 (Cyclophosphamide [600mg/m² iv] + Methotrexate [40mg/m² iv] + 5-Fluoro-Uracil [600mg/m² iv]) q3wk × 9 + Pamidronate [150mg × 2 po] × 4yr
4 (Cyclophosphamide [600mg/m² iv] + 4-Epi-Doxorubicin [60mg/m² iv] + 5-Fluoro-Uracil [600mg/m²]) q3wk × 9 + Pamidronate [150mg × 2 po] × 4yr

21610 89We Uppsala-Örebro part of DBCG89d-Umeå-Uppsala-Örebro Trial, 2-Way (Bergh): Postmenopausal; ER-; N+; Entry MAY-1996 to JUN-1997 (6 patients were entered)

1 (Cyclophosphamide [600mg/m² iv] + Methotrexate [40mg/m² iv] + 5-Fluoro-Uracil [600mg/m² iv]) q3wk × 9
2 (Cyclophosphamide [600mg/m² iv] + 4-Epi-Doxorubicin [60mg/m² iv] + 5-Fluoro-Uracil [600mg/m²]) q3wk × 9

217 Central Institute for Tumours and Allied Disease, Zagreb, Croatia {Kolaric: OCT-1989}

21701 Phase III Trial: Entry ? (not randomised; not received)

1 Cyclophosphamide + Doxorubicin + Cis-Platinum
2 Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil

220 Japanese Foundation for Multidisciplinary Treatment of Cancer {Abe, Ikeda, Inokuchi, Kikuchi, Sakashita, Sawa: SEP-2000 (SECOND REVISED VERSION)}

22001 88P1 Specific Study 12, Group I: ER+; Premenopausal/Postmenopausal; Entry APR-1988 to MAR-1991 (1164 patients were entered)

1 Mitomycin-C [13mg/m² iv d0] then Tamoxifen [20mg/d] × 2yr
2 Mitomycin-C [13mg/m² iv d0] then Tamoxifen [20mg/d] × 2yr + (Cyclophosphamide [100mg/d × 14 po]) q4wk × 2yr

22002 88P2 Specific Study 12, Group II: ER-; Premenopausal/Postmenopausal; Entry APR-1988 to MAR-1991 (730 patients were entered)

1 Mitomycin-C [13mg/m² iv d0] then (Cyclophosphamide [100mg/d × 14 po]) q4wk × 2yr
2 Mitomycin-C [13mg/m² iv d0] then ((Cyclophosphamide [100mg/d × 14 po]) / (Uracil + Ftorafur) [300mg/d × 14 po])) × 2yr alternating

22003 88Q1 Specific Study 13: Premenopausal; Entry APR-1988 to FEB-1990 (76 patients were entered)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 2 perioperative then Tamoxifen [20mg/d] × 2yr + Oöphorectomy
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 2 perioperative then (Tamoxifen [20mg/d] × 2yr + Cyclophosphamide [100mg/d × 14] q4wk) × 2yr

22004 88Q2 Specific Study 13: Postmenopausal; Entry APR-1988 to MAR-1990 (66 patients were entered)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 2 perioperative then (Tamoxifen [20mg/d] + Cyclophosphamide [100mg/d × 14] q4wk) × 2yr
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 2 perioperative then (Tamoxifen [20mg/d] + Cyclophosphamide [100mg/d × 14] q4wk) × 2yr + (Uracil + Ftorafur)

221 University of Granada, Spain {Lara: MAR-1990}

22101 79R1 HUG-1 - Mastectomy then Adjuvant Radiotherapy and Chemotherapy (3-Way): Entry JAN-1979 to DEC-1987 (248 patients were entered; nonstandard randomisation)

1 Radiotherapy then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 then Radiotherapy then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 then Radiotherapy

22102 79R2 HUG-1 - Mastectomy then Adjuvant Radiotherapy and Chemotherapy (2-Way): Entry JAN-1979 to DEC-1987 (99 patients were entered; nonstandard randomisation; not received)

1 Radiotherapy then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 then Radiotherapy then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3

222 People's Hospital, Beijing, China {Rong: NOV-1988}

22201 Adjuvant Chemotherapy: Stage I-III; Entry 1972 ff. (312 patients were entered; nonstandard randomisation; not received)

1 Control
2 Triethylenephosphoramide × 2-4
3 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6-12

223 C.A.M.S. Cancer Institute, Beijing, China {Zhang: MAR-1990}

22301 Mastectomy Trial: Entry 1990 ff. (never started)

1 Radical Mastectomy
2 Simple Mastectomy

224 National Medical Center, Mexico {García Sáinz, de la Huerta, Lira-Puerto, Morales, Sanchez, Torres, Trujillo: JUL-1990 (UPDATED)}

22401 72H Radical Mastectomy Versus Simple Mastectomy Plus Radiotherapy in Early Breast Cancer: Stage I-II; Entry JAN-1972 to FEB-1976 (283 patients were entered; nonstandard randomisation; first 256 patients retained)

1 Radical Mastectomy
2 Simple Mastectomy + Radiotherapy postoperative

22402 89T (Lira-Puerto): Stage III; Entry FEB-1989 to FEB-1990 (not received)

1 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 4 then Radiotherapy then (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 4
2 (5-Fluoro-Uracil + 4-Epi-Doxorubicin + Cyclophosphamide) × 4 then Radiotherapy then (5-Fluoro-Uracil + 4-Epi-Doxorubicin + Cyclophosphamide) × 4

225 Karolinska Hospital, Stockholm, Sweden {Holm: APR-1990}

22501 Dietary Fat Reduction: Age 50-65; Fat Intake Compliance Endpoint; Entry 1983 to 1986 (240 patients were entered; synthetic data only; no recurrence information)

1 Reduced-Fat Diet
2 Control

226 University of Dijon, France {Bartholomot: AUG-1990}

22601 Radiotherapy Trial: Entry 1966 to 1979 (464 patients were received; not randomised; not received)

1 Radiotherapy [locoregional] postoperative
2 Control

227 Dr Daniel den Hoed Cancer Centre, Rotterdam, Netherlands {Jansen: JUN-1991}

22701 Shoulder Exercises after Axillary Node Dissection: Drainage Endpoint; Entry 1987 to 1988 (168 patients were entered; not received)

1 Active Shoulder Exercises starting d1 postoperative
2 Active Shoulder Exercises starting d8 postoperative

228 Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru {Caceres: JUN-1991}

22801 63D3 Lima part of International Coöperative Study: Entry ? (not received)

1 Extended Radical Mastectomy
2 Halsted Mastectomy

22802 Chemotherapy Versus Hormonotherapy Trial: N+; ER+; Entry ? (not received)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 Tamoxifen

229 Hôpital Necker, Paris, France {Baillet: AUG-1991}

22901 82# Radiation Therapy: Entry JAN-1982 ff. (525 patients were entered; not received)

1 Hypofractionated Radiotherapy [23Gy in 4 fractions over 17d]
2 Classical Radiotherapy [45Gy in 25 fractions over 33d]

230 Karl-Franz University, Graz, Austria {Kroll: AUG-1991}

23001 Perioperative Subjective Emotional State: Psychological Endpoint; Entry ? (60 patients were entered; not received)

1 Control
2 Oxazepam

231 Virgina Mason Clinic, Seattle, U.S.A. {Rudolph: DEC-1994}

23101 Unknown: Entry ? (nonexistent; not received)

1 Unknown
2 Unknown

232 Cancer Care Ontario, Canada {Abu-Zahra: DEC-1995 (UPDATED)}

23201 75Q Radiotherapy and Chemotherapy Sequencing: Stage II; N+; Entry JUN-1975 to DEC-1976 (29 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4 then Radiotherapy then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4
2 Radiotherapy then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 8

233 University of Helsinki, Finland {Blomqvist, Tiusanen: JUN-2001 (REVISED VERSION, UPDATED THRICE)}

23301 80S1 Radiotherapy, Chemotherapy and Tamoxifen Trial: N+; Stage II; Entry DEC-1980 to DEC-1984 (200 patients were entered)

1 (Cyclophosphamide + Doxorubicin + Ftorafur) × 8
2 Radiotherapy
3 Radiotherapy + (Cyclophosphamide + Doxorubicin + Ftorafur) × 8
4 Radiotherapy + (Cyclophosphamide + Doxorubicin + Ftorafur) × 8 + Tamoxifen [40mg/d] × 2yr

23302 80S2 Tamoxifen Trial: N+; Locally Advanced; Stage III; Radical Mastectomy; Axillary Clearance; Entry AUG-1981 to FEB-1986 (61 patients were entered)

1 Radiotherapy + (Cyclophosphamide + Doxorubicin + Ftorafur) × 8
2 Radiotherapy + (Cyclophosphamide + Doxorubicin + Ftorafur) × 8 + Tamoxifen [40mg/d] × 2yr

23303 90@1 Toremifene Trial: T1-3 N1-2 M0; Postmenopausal; Second Randomisation from 23304; Entry MAY-1991 to JUN-1993 (114 patients were entered)

1 Tamoxifen
2 Toremifene

23304 90@2 Clodronate Adjuvant Trial: T1-3 N1-2 M0; Postmenopausal Sub-Set; Entry OCT-1990 to JUL-1993 (137 patients were entered)

1 Clodronate [1600mg/d]
2 Control

23305 90@3 Clodronate Adjuvant Trial: T1-3 N1-2 M0; Premenopausal Sub-Set; Entry OCT-1990 to JUL-1993 (162 patients were entered; not received)

1 Clodronate [1600mg/d]
2 Control

234 North Sweden Breast Cancer Group, Umeå, Sweden {Andersson, Bjurstam, Frisell, Nyström, Tabar: SEP-1992}

23401 77V1 WE Study (Kopparberg): 'Population Cluster' Randomisation; 'eligibles'; Entry JUL-1977 to FEB-1980 (56332 patients were entered)

1 Mammography
2 Control

23402 77V2 WE Study (Östergötland): 'Population Cluster' Randomisation; 'eligibles'; Entry MAY-1978 to MAR-1981 (75550 patients were entered)

1 Mammography
2 Control

23403 76Y1 MG Study (Malmö): 'eligibles'; Entry OCT-1976 to AUG-1978 (41477 patients were entered)

1 Mammography
2 Control

23404 76Y2 MG Study (Göteborg): 'eligibles'; Entry DEC-1982 to APR-1984 (51551 patients were entered)

1 Mammography
2 Control

23405 81G1 Stockholm Study: Birth-Date Randomisation; 'eligibles'; Entry MAR-1981 to MAY-1983 (59855 patients were entered)

1 Mammography
2 Control

23406 77V3 WE Study (Kopparberg): 'Population Cluster' Randomisation; 'ineligibles'; Entry JUL-1977 to FEB-1980 (7 patients were entered)

1 Mammography
2 Control

23407 77V4 WE Study (Östergötland): 'Population Cluster' Randomisation; 'ineligibles'; Entry MAY-1978 to MAR-1981 (1067 patients were entered)

1 Mammography
2 Control

23408 76Y3 MG Study (Malmö): 'ineligibles'; Entry OCT-1976 to AUG-1978 (806 patients were entered)

1 Mammography
2 Control

23409 76Y4 MG Study (Göteborg): 'ineligibles'; Entry DEC-1982 to APR-1984 (651 patients were entered)

1 Mammography
2 Control

23410 81G2 Stockholm Study: Birth-Date Randomisation; 'ineligibles'; Entry MAR-1981 to MAY-1983 (945 patients were entered)

1 Mammography
2 Control

23411 77V5 WE Study (Kopparberg): 'Population Cluster' Randomisation; Entry JUL-1977 to FEB-1980 (56339 patients were entered)

1 'Ineligible, arrived alive'
2 'Eligible'

23412 77V6 WE Study (Östergötland): 'Population Cluster' Randomisation; Entry MAY-1978 to MAR-1981 (76614 patients were entered)

1 'Ineligible, arrived alive'
2 'Eligible'

23413 76Y5 MG Study (Malmö): Entry OCT-1976 to AUG-1978 (42273 patients were entered)

1 'Ineligible, arrived alive'
2 'Eligible'

23414 76Y6 MG Study (Göteborg): Entry DEC-1982 to APR-1984 (52201 patients were entered)

1 'Ineligible, arrived alive'
2 'Eligible'

23415 81G3 Stockholm Study: Birth-Date Randomisation; Entry MAR-1981 to MAY-1983 (60776 patients were entered)

1 'Ineligible, arrived alive'
2 'Eligible'

23416 77V7 WE Study (Kopparberg), 'Screening' stratum: 'Population Cluster' Randomisation; Entry JUL-1977 to FEB-1980 (56339 patients were entered)

1 'Ineligible, arrived alive'
2 'Eligible'

23417 77V8 WE Study (Östergötland), 'Screening' stratum: 'Population Cluster' Randomisation; Entry MAY-1978 to MAR-1981 (76617 patients were entered)

1 'Ineligible, arrived alive'
2 'Eligible'

23418 76Y7 MG Study (Malmö), 'Screening' stratum: Entry OCT-1976 to AUG-1978 (42283 patients were entered)

1 'Ineligible, arrived alive'
2 'Eligible'

23419 76Y8 MG Study (Göteborg), 'Screening' stratum: Entry DEC-1982 to APR-1984 (52202 patients were entered)

1 'Ineligible, arrived alive'
2 'Eligible'

23420 81G4 Stockholm Study, 'Screening' stratum: Birth-Date Randomisation; Entry MAR-1981 to MAY-1983 (60800 patients were entered)

1 'Ineligible, arrived alive'
2 'Eligible'

23421 77V9 WE Study (Kopparberg), 'Control' stratum: 'Population Cluster' Randomisation; Entry JUL-1977 to FEB-1980 (56339 patients were entered)

1 'Ineligible, arrived alive'
2 'Eligible'

23422 77V@ WE Study (Östergötland), 'Control' stratum: 'Population Cluster' Randomisation; Entry MAY-1978 to MAR-1981 (76617 patients were entered)

1 'Ineligible, arrived alive'
2 'Eligible'

23423 76Y9 MG Study (Malmö), 'Control' stratum: Entry OCT-1976 to AUG-1978 (42283 patients were entered)

1 'Ineligible, arrived alive'
2 'Eligible'

23424 76Ya MG Study (Göteborg), 'Control' stratum: Entry DEC-1982 to APR-1984 (52202 patients were entered)

1 'Ineligible, arrived alive'
2 'Eligible'

23425 81G5 Stockholm Study, 'Control' stratum: Birth-Date Randomisation; Entry MAR-1981 to MAY-1983 (60800 patients were entered)

1 'Ineligible, arrived alive'
2 'Eligible'

235 Istituto di Clinica Oncologica e di Ricerca sui Tumori Universita' di Messina, Italy {Spadaro: MAY-1994}

23501 Surgery Trial: Age < 71; Tumour 3cm or less; T1-2 N0-1 M0; Entry ? (not started by JUN-1995; not received)

1 Tumorectomy
2 Quadrantectomy

236 Hospital 20 de Noviembre, ISSSTE, CMN Siglo XXI IMSS and CMO IMMS, Guadalajara, Mexico {Erazo Valle, García-Sancho, Lira Puerto, Olguín Erikson, Torrecillas, Yoma Medina, Zepeda del Río: FEB-1996 (UPDATED)}

23601 87M FEC vs. FAC: Entry FEB-1987 to AUG-1991 (153 patients were entered)

1 (5-Fluoro-Uracil + 4-Epi-Doxorubicin + Cyclophosphamide) × 4 induction preoperative then Radiotherapy then (5-Fluoro-Uracil + 4-Epi-Doxorubicin + Cyclophosphamide) × 5 consolidation
2 (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 4 induction preoperative then Radiotherapy then (5-Fluoro-Uracil + Doxorubicin + Cyclophosphamide) × 5 consolidation

237 Italian Oncology Group for Clinical Research {Buzzi, Camisa, Cocconi, Colozza, Di Sarra: JUL-2001 (SECOND REVISED VERSION)}

23701 OM Parma and OSMN R. Emilia Trial: Stage III; Locally Advanced; T3b-4/(T1-4 N2 M0); Radical Mastectomy; Premenopausal/Postmenopausal; ER-/ER?/ER+; Entry MAR-1978 to MAR-1983 (54 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4 preoperative then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4 then Radiotherapy
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Tamoxifen [10mg bd]) × 4 preoperative then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Tamoxifen [10mg bd]) × 4 then Radiotherapy

23702 89Z GOIRC SANG 3: Stage II; N10+; Premenopausal/Postmenopausal; Entry OCT-1989 to NOV-1993 (113 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 (Cis-Platinum + Etoposide) × 3 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 then (Doxorubicin + 5-Fluoro-Uracil + Folinic Acid) × 3

23703 GOIRC SANG 1 Pilot: Biological Parameters Endpoint; Entry 1990 (40 patients were entered; part of 23705-23706; not received)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4 preoperative
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + 4-Epi-Doxorubicin + Vincristine) × 4 rotational weave preoperative

23704 GOIRC SANG 4: Stage III; Locoregionally Recurrent; Premenopausal/Postmenopausal; Objective Response Endpoint; Entry OCT-1989 to NOV-1992 (132 patients were entered; not received)

1 (4-Epi-Doxorubicin [d1] + (Methotrexate + Vincristine + Folinic Acid) [d1,8] + Cis-Platinum [d2]) × 4 preoperative
2 (4-Epi-Doxorubicin [d1] + (Methotrexate + Etoposide) [d1,8] + Cis-Platinum [d2]) × 4 preoperative
3 ((Cis-Platinum + Etoposide) [d1,2] + Methotrexate [d1,8] + Mitomycin-C [d1,42]) × 4 preoperative

23705 90Y1 GOIRC SANG 1: (Stage I-II, Tumour > 2·5cm)/(any T, N+); Premenopausal; Entry DEC-1990 to MAR-1995 (98 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4 preoperative then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 postoperative
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + 4-Epi-Doxorubicin + Vincristine) × 4 rotational weave preoperative then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 postoperative

23706 90Y2 GOIRC SANG 1: (Stage I-II, Tumour > 2·5cm)/(any T, N+); Postmenopausal; Entry NOV-1990 to APR-1995 (113 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 4 preoperative then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 postoperative then Tamoxifen
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + 4-Epi-Doxorubicin + Vincristine) × 4 rotational weave preoperative then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 3 postoperative then Tamoxifen

23707 90Z1 GOIRC SANG 2: (Stage I, N-, Unfavourable)/(Stage II, N1-9); Premenopausal; Entry DEC-1990 to JAN-1994 (185 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 4-Epi-Doxorubicin [30mg/m²/wk] × 16wk

23708 90Z2 GOIRC SANG 2: (Stage I, N-, Unfavourable)/(Stage II, N1-9); Postmenopausal; Entry NOV-1990 to DEC-1993 (163 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 then Tamoxifen
2 4-Epi-Doxorubicin [30mg/m²/wk] × 16wk then Tamoxifen

23709 94J1 GOIRC SANG 2B R1: Moderate to High Risk; Stage I-II; N1-3; Premenopausal; ER-/ER?; Entry SEP-1994 to APR-2000 (489 patients were entered into 23709-23711; not received)

1 (Cyclophosphamide [600mg/m² d1,8] + Methotrexate [40mg/m² d1,8] + 5-Fluoro-Uracil [600mg/m² d1,8]) q28d × 6
2 (Cyclophosphamide [600mg/m² d1,8 c1,2,4,5] + Methotrexate [40mg/m² d1,8 c1,3,4,6] + 5-Fluoro-Uracil [600mg/m² d1,8 c2,3,5,6] + 4-Epi-Doxorubicin [40mg/m² d1,8] + Vincristine [1·4mg/m² d1]) q28d × 6 rotational weave

23710 94J2 GOIRC SANG 2B R1: Moderate to High Risk; Stage I-II; N1-3; Premenopausal; ER+; Entry SEP-1994 to APR-2000 (489 patients were entered into 23709-23711; not received)

1 (Cyclophosphamide [600mg/m² d1,8] + Methotrexate [40mg/m² d1,8] + 5-Fluoro-Uracil [600mg/m² d1,8]) q28d × 6 then Tamoxifen [20mg/d] × 5yr
2 (Cyclophosphamide [600mg/m² d1,8 c1,2,4,5] + Methotrexate [40mg/m² d1,8 c1,3,4,6] + 5-Fluoro-Uracil [600mg/m² d1,8 c2,3,5,6] + 4-Epi-Doxorubicin [40mg/m² d1,8] + Vincristine [1·4mg/m² d1]) q28d × 6 rotational weave then Tamoxifen [20mg/d] × 5yr

23711 94J3 GOIRC SANG 2B R1: Moderate to High Risk; Stage I-II; N1-3; Postmenopausal; Entry SEP-1994 to APR-2000 (489 patients were entered into 23709-23711; not received)

1 (Cyclophosphamide [600mg/m² d1,8] + Methotrexate [40mg/m² d1,8] + 5-Fluoro-Uracil [600mg/m² d1,8]) q28d × 6 then Tamoxifen [20mg/d] × 5yr
2 (Cyclophosphamide [600mg/m² d1,8 c1,2,4,5] + Methotrexate [40mg/m² d1,8 c1,3,4,6] + 5-Fluoro-Uracil [600mg/m² d1,8 c2,3,5,6] + 4-Epi-Doxorubicin [40mg/m² d1,8] + Vincristine [1·4mg/m² d1]) q28d × 6 rotational weave then Tamoxifen [20mg/d] × 5yr

23712 94J4 GOIRC SANG 2B R2: Stage II; N4-9; Premenopausal; ER-/ER?; Entry SEP-1994 to APR-2000 (142 patients were entered into 23712-23714; not received)

1 Doxorubicin [75mg/m² d1] q21d × 4 then (Cyclophosphamide [600mg/m² d1,8] + Methotrexate [40mg/m² d1,8] + 5-Fluoro-Uracil [600mg/m² d1,8]) q28d × 4
2 (Cyclophosphamide [600mg/m² d1,8 c1,2,4,5] + Methotrexate [40mg/m² d1,8 c1,3,4,6] + 5-Fluoro-Uracil [600mg/m² d1,8 c2,3,5,6] + 4-Epi-Doxorubicin [40mg/m² d1,8] + Vincristine [1·4mg/m² d1]) q28d × 6 rotational weave

23713 94J5 GOIRC SANG 2B R2: Stage II; N4-9; Premenopausal; ER+; Entry SEP-1994 to APR-2000 (142 patients were entered into 23712-23714; not received)

1 Doxorubicin [75mg/m² d1] q21d × 4 then (Cyclophosphamide [600mg/m² d1,8] + Methotrexate [40mg/m² d1,8] + 5-Fluoro-Uracil [600mg/m² d1,8]) q28d × 4 then Tamoxifen [20mg/d] × 5yr
2 (Cyclophosphamide [600mg/m² d1,8 c1,2,4,5] + Methotrexate [40mg/m² d1,8 c1,3,4,6] + 5-Fluoro-Uracil [600mg/m² d1,8 c2,3,5,6] + 4-Epi-Doxorubicin [40mg/m² d1,8] + Vincristine [1·4mg/m² d1]) q28d × 6 rotational weave then Tamoxifen [20mg/d] × 5yr

23714 94J6 GOIRC SANG 2B R2: Stage II; N4-9; Postmenopausal; Entry SEP-1994 to APR-2000 (142 patients were entered into 23712-23714; not received)

1 Doxorubicin [75mg/m² d1] q21d × 4 then (Cyclophosphamide [600mg/m² d1,8] + Methotrexate [40mg/m² d1,8] + 5-Fluoro-Uracil [600mg/m² d1,8]) q28d × 4 then Tamoxifen [20mg/d] × 5yr
2 (Cyclophosphamide [600mg/m² d1,8 c1,2,4,5] + Methotrexate [40mg/m² d1,8 c1,3,4,6] + 5-Fluoro-Uracil [600mg/m² d1,8 c2,3,5,6] + 4-Epi-Doxorubicin [40mg/m² d1,8] + Vincristine [1·4mg/m² d1]) q28d × 6 rotational weave then Tamoxifen [20mg/d] × 5yr

23715 93R1 GOIRC SANG 3B: Very High Risk; Premenopausal; N10+; ER-/ER?; Entry DEC-1993 ff. (target 100 patients for 23715-23717; not received)

1 Doxorubicin [75mg/m² d1] q21d × 4 then (Cyclophosphamide [600mg/m² d1,8] + Methotrexate [40mg/m² d1,8] + 5-Fluoro-Uracil [600mg/m² d1,8]) q28d × 4
2 ((Methotrexate [100mg/m² d1,8] then Folinic Acid [7·5mg q6h d2,9] × 4) + Cis-Platinum [80mg/m² d2] + 4-Epi-Doxorubicin [60mg/m² d?] + Etoposide [100mg/m² d1,2]) q21d × 2 then ((Methotrexate [100mg/m² d1,8] then Folinic Acid [7·5mg q6h d2,9] × 4) + Cis-Platinum [80mg/m² d2] + 4-Epi-Doxorubicin [60mg/m² d?] + Vincristine [1·4mg/m² d1,8]) q21d × 2 then ((Methotrexate [100mg/m² d1,8] then Folinic Acid [7·5mg q6h d2,9] × 4) + Cis-Platinum [80mg/m² d2] + Etoposide [100mg/m² d1,2] + Mitomycin-C [6mg/m² d1]) q21d × 2

23716 93R2 GOIRC SANG 3B: Very High Risk; Premenopausal; N10+; ER+; Entry DEC-1993 ff. (target 100 patients for 23715-23717; not received)

1 Doxorubicin [75mg/m² d1] q21d × 4 then (Cyclophosphamide [600mg/m² d1,8] + Methotrexate [40mg/m² d1,8] + 5-Fluoro-Uracil [600mg/m² d1,8]) q28d × 4 then Tamoxifen [20mg/d] × 5yr
2 ((Methotrexate [100mg/m² d1,8] then Folinic Acid [7·5mg q6h d2,9] × 4) + Cis-Platinum [80mg/m² d2] + 4-Epi-Doxorubicin [60mg/m² d?] + Etoposide [100mg/m² d1,2]) q21d × 2 then ((Methotrexate [100mg/m² d1,8] then Folinic Acid [7·5mg q6h d2,9] × 4) + Cis-Platinum [80mg/m² d2] + 4-Epi-Doxorubicin [60mg/m² d?] + Vincristine [1·4mg/m² d1,8]) q21d × 2 then ((Methotrexate [100mg/m² d1,8] then Folinic Acid [7·5mg q6h d2,9] × 4) + Cis-Platinum [80mg/m² d2] + Etoposide [100mg/m² d1,2] + Mitomycin-C [6mg/m² d1]) q21d × 2 then Tamoxifen [20mg/d] × 5yr

23717 93R3 GOIRC SANG 3B: Very High Risk; Postmenopausal; N10+; Entry DEC-1993 ff. (target 100 patients for 23715-23717; not received)

1 Doxorubicin [75mg/m² d1] q21d × 4 then (Cyclophosphamide [600mg/m² d1,8] + Methotrexate [40mg/m² d1,8] + 5-Fluoro-Uracil [600mg/m² d1,8]) q28d × 4 then Tamoxifen [20mg/d] × 5yr
2 ((Methotrexate [100mg/m² d1,8] then Folinic Acid [7·5mg q6h d2,9] × 4) + Cis-Platinum [80mg/m² d2] + 4-Epi-Doxorubicin [60mg/m² d?] + Etoposide [100mg/m² d1,2]) q21d × 2 then ((Methotrexate [100mg/m² d1,8] then Folinic Acid [7·5mg q6h d2,9] × 4) + Cis-Platinum [80mg/m² d2] + 4-Epi-Doxorubicin [60mg/m² d?] + Vincristine [1·4mg/m² d1,8]) q21d × 2 then ((Methotrexate [100mg/m² d1,8] then Folinic Acid [7·5mg q6h d2,9] × 4) + Cis-Platinum [80mg/m² d2] + Etoposide [100mg/m² d1,2] + Mitomycin-C [6mg/m² d1]) q21d × 2 then Tamoxifen [20mg/d] × 5yr

238 Universitäts-Frauenklinik and Poliklinik Homburg/Saar, Germany {Brandner: MAY-1994}

23801 Drain Trial: Drainage Endpoint; Entry ? (not received)

1 Redon Drain
2 Slit Drain

239 C.A.M.S., China {Chen, Pan: SEP-2000 (REVISED VERSION)}

23901 91R1 National Randomised Study of Early Breast Cancer Surgical Options (2-Way): Postmenopausal/(Without Living Child); Age < 70; Stage II; Entry OCT-1991 to AUG-1996 (4181 patients were entered)

1 Radical Mastectomy
2 Simple Mastectomy

23902 91R2 National Randomised Study of Early Breast Cancer Surgical Options (4-Way): Premenopausal with Living Child; Age < 70; Stage II; Entry OCT-1991 to AUG-1996 (2343 patients were entered)

1 Simple Mastectomy + Chemotherapy
2 Radical Mastectomy + Chemotherapy
3 Simple Mastectomy + Ovarian Ablation + Chemotherapy
4 Radical Mastectomy + Ovarian Ablation + Chemotherapy

240 U.K.C.C.C.R. National Adjuvant Breast Cancer Trial {Bliss, Yarnold: MAY-1994}

24001 93A1 ABC Trial: Postmenopausal; Entry JAN-1993 to SEP-2000 (1337 patients were entered by JUL-2000; not received)

1 Tamoxifen + Chemotherapy (according to local practice)
2 Tamoxifen

24002 93A2 ABC Trial: Premenopausal/Perimenopausal; Entry JAN-1993 to SEP-2000 (251 patients were entered by JUL-2000; not received)

1 Tamoxifen + Chemotherapy (according to local practice)
2 Tamoxifen

24003 93A3 ABC Trial: Premenopausal/Perimenopausal; Entry JAN-1993 to SEP-2000 (284 patients were entered by JUL-2000; not received)

1 Tamoxifen + Ovarian Suppression
2 Tamoxifen

24004 93A4 ABC Trial: Premenopausal/Perimenopausal; Entry JAN-1993 to SEP-2000 (279 patients were entered by JUL-2000; not received)

1 Tamoxifen + Chemotherapy (according to local practice)
2 Tamoxifen
3 Tamoxifen + Chemotherapy (according to local practice) + Ovarian Suppression
4 Tamoxifen + Ovarian Suppression

24005 93A5 ABC Trial: Premenopausal/Perimenopausal; Entry JAN-1993 to SEP-2000 (101 patients were entered by JUL-2000; not received)

1 Tamoxifen + Ovarian Suppression + Chemotherapy (according to local practice)
2 Tamoxifen + Ovarian Suppression

24006 93A6 ABC Trial: Premenopausal/Perimenopausal; Entry JAN-1993 to SEP-2000 (1532 patients were entered by JUL-2000; not received)

1 Tamoxifen + Chemotherapy (according to local practice) + Ovarian Suppression
2 Tamoxifen + Chemotherapy (according to local practice)

242 University of Pretoria, South Africa {Falkson, Jooste, Voges: NOV-1995 (UPDATED)}

24201 87P Buserelin Trial - Phase III Adjuvant Study: Premenopausal; N+ Operable; Axillary Dissection; CMF Patients; Entry AUG-1987 to JUN-1994 (149 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m + Buserelin × 5yr

243 Gruppo Sassari-Cagliari, Italy {Farris: MAY-1994}

24301 88E Surgery Trial: Age 71+; T1-3 N0-1 M0; Entry ?1988 ff. (137 patients were entered; not received)

1 Tamoxifen
2 Mastectomy + Tamoxifen

245 Hadassah University Hospital, Jerusalem, Israel {Gez: MAY-1994}

24501 Antiemetic Trial: Breast Cancer Patients Receiving CMF; Vomiting Endpoint; Entry ? (not received)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Methylprednisolone [125mg]
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Methylprednisolone [125mg] × 2

246 Hellenic Coöperative Oncology Group, Greece {Fountzilas, Papakostaki: APR-2001}

24601 86N Chemotherapy Trial: Stage II; N+; Entry MAY-1986 to DEC-1992 (392 patients were entered)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 Cyclophosphamide + Mitozantrone + 5-Fluoro-Uracil

24602 92B1 HE1092: Premenopausal; ER+; N+; Entry JUN-1992 to MAR-1998 (176 patients were entered)

1 (Cyclophosphamide + Mitozantrone + 5-Fluoro-Uracil) then Ovarian Ablation + Tamoxifen
2 (Cyclophosphamide + Mitozantrone + 5-Fluoro-Uracil) then Ovarian Ablation + Buserelin + Tamoxifen

24603 92B2 HE1092: Postmenopausal; ER+; N+; Entry JUN-1989 to OCT-1998 (280 patients were entered)

1 Tamoxifen
2 (Cyclophosphamide + Mitozantrone + 5-Fluoro-Uracil) + Tamoxifen

24604 97C HE1097: N+; Entry DEC-1996 to NOV-2000 (592 patients were entered; no events reported; blinded until publication)

1 4-Epi-Doxorubicin + Paclitaxel + Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 4-Epi-Doxorubicin + Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

247 Centre Hospitalier Lyon Sud, France {Lasset, Lehingue, Montbarbon, Romestaing: MAY-1996 (UPDATED)}

24701 85R Radiotherapy Trial: Lesions > 5mm; Age < 70; Conservative Surgery; Entry JAN-1985 to SEP-1992 (1024 patients were entered)

1 Control
2 Iridium [boost]

24702 90H Surgery and Chemo-Radiotherapy Trial: Lesions 3-7cm; Age < 66; Entry JAN-1990 ff. (not received)

1 Mastectomy
2 Tumorectomy + Chemotherapy + Radiotherapy

24703 Internal Mammary Chain Irradiation Trial: Mastectomy; Entry post-1995 (target 1400 patients; not received)

1 Radiotherapy including internal mammary chain
2 Radiotherapy excluding internal mammary chain

248 Ospedale San Raffaele, Milan, Italy {Ayala: MAY-1994}

24801 85X Oöphorectomy Trial: Operable; Radical Mastectomy; Premenopausal/Postmenopausal; T1-4 N0-2 M0; Entry ?1985 ff. (34 patients were entered; not received)

1 Control
2 Oöphorectomy

249 Hospital Universitario San Carlos, Madrid, Spain {Diaz Rubio: MAY-1994}

24901 Antiemetic Trial: Vomiting Endpoint; Entry ? (not received)

1 Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil + Thiethylperazine + Methylprednisolone
2 Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil + Thiethylperazine

24902 88V Cardiotoxicity Trial: Cardiac Function Endpoint; Entry JUN-1988 to JUN-1991 (158 patients were entered; not received)

1 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6

250 Georgetown University Medical Center, Washington, U.S.A. {Spear: MAY-1994}

25001 Methylprednisolone Trial: Patients Undergoing Immediate Breast Reconstruction (Gel-Saline Double-Lumen Implant, 40cc Saline); Cosmetic Outcome Endpoint; Entry ? (not received)

1 Control
2 Methylprednisolone [16mg]

251 Osaka Breast Cancer Study Group, Japan {Miyauchi, Sawa, Takatsuka, Yayoi: AUG-1995}

25101 86F1 Tamoxifen Trial: N0; Stage I-II; Entry DEC-1986 to NOV-1990 (251 patients were entered)

1 Tamoxifen [40mg/d] × 2yr
2 Control

25102 86F2 Tamoxifen Trial: N+; Stage I-II; Entry FEB-1987 to DEC-1991 (91 patients were entered)

1 Tamoxifen [40mg/d] × 2yr
2 Cyclophosphamide [100mg/d]

25103 Neoadjuvant Intra-Arterial Chemotherapy Trial: Locally Advanced; Stage IIIa-b; Radical Mastectomy; Age < 71; Entry JAN-1986 to JUN-1992 (76 patients were entered; not received)

1 4-Epi-Doxorubicin [20mg iv] q2wk × 1yr + (5-Fluoro-Uracil [200mg/d po] + Tamoxifen [20mg/d]) × 2yr
2 4-Epi-Doxorubicin [50mg ia d1,4,7] preoperative then 4-Epi-Doxorubicin [20mg iv] q2wk × 1yr + (5-Fluoro-Uracil [200mg/d po] + Tamoxifen [20mg/d]) × 2yr
3 4-Epi-Doxorubicin [50mg iv d1,4,7] preoperative then 4-Epi-Doxorubicin [20mg iv] q2wk × 1yr + (5-Fluoro-Uracil [200mg/d po] + Tamoxifen [20mg/d]) × 2yr

252 University of Edinburgh, Scotland {Cameron, Chetty, Forouhi: MAY-2001 (UPDATED)}

25201 90J1 Large Tumour Study: Operable; Tumour > 3cm; T2-3 N0 M0; ER-; Age < 70; Entry MAR-1990 to JUL-1995 (42 patients were entered)

1 (Systemic Chemotherapy) × 4 preoperative then (Systemic Chemotherapy) × 2 postoperative
2 Tamoxifen postoperative

25202 90J2 Large Tumour Study: Operable; Tumour > 3cm; T2-3 N1 M0; ER-; Premenopausal; Age < 70; Entry JAN-1990 to JUN-1995 (22 patients were entered)

1 (Systemic Chemotherapy) × 4 preoperative then (Systemic Chemotherapy) × 2 postoperative
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 postoperative

25203 90J3 Large Tumour Study: Operable; Tumour > 3cm; T2-3 N1 M0; ER-; Postmenopausal; Age < 70; Entry MAR-1990 to SEP-1995 (17 patients were entered)

1 (Systemic Chemotherapy) × 4 preoperative then (Systemic Chemotherapy) × 2 postoperative
2 Tamoxifen postoperative

25204 90J4 Large Tumour Study: Operable; Tumour > 3cm; T2-3 N0 M0; ER+; Premenopausal; Age < 70; Entry FEB-1990 to AUG-1995 (15 patients were entered)

1 Goserelin preoperative + Oöphorectomy postoperative
2 Tamoxifen postoperative

25205 90J5 Large Tumour Study: Operable; Tumour > 3cm; T2-3 N1 M0; ER+; Premenopausal; Age < 70; Entry JUN-1990 to AUG-1995 (22 patients were entered)

1 Goserelin preoperative + Oöphorectomy postoperative
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 postoperative

25206 90J6 Large Tumour Study: Operable; Tumour > 3cm; T2-3 N0-1 M0; ER+; Postmenopausal; Age < 70; Entry FEB-1990 to AUG-1995 (53 patients were entered)

1 Tamoxifen preoperative + Tamoxifen postoperative
2 Tamoxifen postoperative

253 National Institute of Oncology, Budapest, Hungary {Juhos: MAY-1994}

25301 85S Tamoxifen and Aminoglutethimide Trial: Primary Breast Cancer; Postmenopausal; ER+; N+; Entry SEP-1985 to NOV-1989 (not received)

1 Tamoxifen × 2yr
2 (Aminoglutethimide + Cortisone) × 2yr

254 Istituto Regina Elena, Rome, Italy {Pollera: MAY-1994}

25401 Antiemetics Trial: Stage II; CMF Patients; Vomiting Endpoint; Entry JUN-1986 to FEB-1987 (not received)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Dexamethasone
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Metoclopramide
3 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Dexamethasone + Metoclopramide
4 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

255 U.K. Screen-Detected DCIS Trial Group, U.K. {Joslin, Stewart: APR-1995}

25501 DCIS Trial (4-Way): Screen-Detected DCIS; Complete Local Excision; Entry MAY-1990 ff. (825 patients were entered by AUG-1995; target ?2000; not received)

1 Control
2 Radiotherapy
3 Tamoxifen [20mg/d] × 5yr
4 Radiotherapy + Tamoxifen [20mg/d] × 5yr

25502 DCIS Trial: Screen-Detected DCIS (2-Way Sub-Set); Complete Local Excision; Entry MAY-1990 ff. (339 patients were entered by 31-MAR-1995; not received)

1 Control
2 Tamoxifen [20mg/d] × 5yr

25503 DCIS Trial: Screen-Detected DCIS (2-Way Sub-Set); Complete Local Excision; Entry MAY-1990 ff. (30 patients were entered by 31-MAR-1995; not received)

1 Tamoxifen [20mg/d] × 5yr
2 Radiotherapy + Tamoxifen [20mg/d] × 5yr

256 Breast Cancer Study Group of the Comprehensive Cancer Centre Limburg, Netherlands {Blijham, Hupperets, Schouten, Wils: JUN-2000 (REVISED VERSION, UPDATED TWICE)}

25601 82@ Dutch MPA Trial: N+; Patients Receiving FAC; Entry FEB-1982 to AUG-1987 (409 patients were entered)

1 Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil
2 Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil + Medroxyprogesterone Acetate × 6m

25602 IKL Trial: Postmenopausal; N+; Entry 1988 to 1996 (duplicated as 20002; not received)

1 Tamoxifen [20mg/d] × 4yr
2 4-Epi-Doxorubicin [50mg/m² iv d1,8] + Tamoxifen [20mg/d] × 4yr

257 Jules Bordet Institute, Brussels, Belgium {Bartholomeus, Paesman, Piccart: JUN-2000 (REVISED VERSION)}

25701 88R Classical CMF Versus EC Standard Dose Versus EC High Dose in Node Positive Breast Cancer (Operable): N+; Age < 66; Entry JUN-1988 to APR-1997 (804 patients were entered)

1 (4-Epi-Doxorubicin + Cyclophosphamide) [high dose] × 6
2 (4-Epi-Doxorubicin + Cyclophosphamide) [conventional dose] × 6
3 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil

25702 98D BIG02-97: Intergroup Phase III; N+; Entry JUN-1998 ff. (1363 patients were entered by JUN-2000; target 2200; not received)

1 (Docetaxel + Doxorubicin) concurrent/sequential then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil)
2 Doxorubicin + Cyclophosphamide/Nil then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil)

258 St Vincent's Hospital, Dublin, Ireland {Coveney: MAY-1995}

25801 Suturing Trial (Coveney): Patients Eligible for Modified Radical Mastectomy (Axillary Clearance to Level III); Cosmetic Outcome Endpoint; Entry ? (not received)

1 Fixation of Skin Flaps
2 Control

259 Australia and New Zealand Breast Cancer Trials Group {Coates, Forbes: SEP-1994}

25901 Unknown: Entry ? (not received)

1 Unknown
2 Unknown

260 University of Florence, Italy {Del Turco: JAN-1995}

26001 85T Follow-Up Trial: Premenopausal/Postmenopausal; Unilateral Invasive Breast Carcinoma Without Metastases; Entry JAN-1985 to DEC-1986 (1243 patients were entered; not received)

1 Intensive Follow-Up
2 Clinical Follow-Up

261 National Cancer Institute of Canada Clinical Trials Group, Ontario, Canada {Albain, Bramwell, Levine, Myles, Pater: SEP-2000 (THIRD REVISED VERSION)}

26101 84D1 T.E.C.T.G. and NCI-C MA.4 (Pater): ER+/PR+; Postmenopausal; N+; Entry JAN-1984 to DEC-1990 (736 patients were entered)

1 Tamoxifen × 2yr
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m + Tamoxifen × 2yr

26102 84D2 T.E.C.T.G. and NCI-C MA.4 (Pater): ER-; Postmenopausal; N+; Entry JUN-1984 to JUL-1985 (22 patients were entered)

1 Control
2 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m

26103 89R NCI-C MA.5 (Levine): Premenopausal; N+; Entry DEC-1989 to JUL-1993 (716 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6m
2 (Cyclophosphamide + 4-Epi-Doxorubicin + 5-Fluoro-Uracil) [dose-intensive cycle] × 6m

26104 Intergroup Trial NCI-C MA.9 (Albain): Postmenopausal; N+; ER+; Entry 1989 ff. (duplicated as 1208, SWOG 8814; not received)

1 Tamoxifen × 5yr
2 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6m + Tamoxifen × 5yr concurrent
3 (Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil) × 6m then Tamoxifen × 5yr

26105 93B NCI-C MA.12 (Bramwell, Pater): Post-Chemotherapy Randomisation; Premenopausal; N+/(High Risk, N-); Entry JAN-1993 ff. (672 patients were entered; not received)

1 (Cyclophosphamide + Methotrexate/4-Epi-Doxorubicin + 5-Fluoro-Uracil) × 6m / (Doxorubicin + Cyclophosphamide) × 4m
2 (((Cyclophosphamide + Methotrexate/4-Epi-Doxorubicin + 5-Fluoro-Uracil) × 6m / (Doxorubicin + Cyclophosphamide) × 4m)) then Tamoxifen × 5yr

26106 96M NCIC MA.14: Postmenopausal; Stage I-II; Entry 1996 ff. (not received)

1 Tamoxifen [20mg/d] × 5yr
2 Octreotide [90mg/m² depot] × 5yr + Tamoxifen [20mg/d] × 5yr

262 Munich, Germany {Graeff, Jänicke, Meisner: JUN-2001 (SECOND REVISED VERSION)}

26201 93S Chemo-N0-Trial: High Risk; N0; (PAI-1 > 14ng/mg Protein) / (uPA > 3ng/mg Protein); 1-5cm Tumours; Age < 70; Entry JUN-1993 to DEC-1998 (242 patients were entered)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6
2 Control

263 Elim Hospital, Hamburg, Germany {Bijnens, Rossbach: JUL-1995}

26301 85W PeCT Study: Entry JAN-1985 to DEC-1988 (607 patients were entered)

1 (Cyclophosphamide + 4-Epi-Doxorubicin) perioperative
2 Control

264 Northern General Hospital, Sheffield, U.K. {Rogers, Wyman: JUN-1995}

26401 Laser Scalpel Trial: Modified Radical Mastectomy; Surgical Endpoints; Entry ? (not received)

1 Conventional Scalpel
2 NdYAG Laser Scalpel

265 C.H.U. de Hautepierre, Strasbourg, France {Dufour: JUN-1995}

26501 DDC Trial: Patey Mastectomy; High Risk; Entry ? (64 patients were entered; not received)

1 Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil + Sodium Dithiocarb
2 Cyclophosphamide + Doxorubicin + 5-Fluoro-Uracil

266 University of Erlanger, Germany {Jager: JUN-1995}

26601 86V Tumour Marker Study: Entry 1986 ff. (46 patients were entered; not received)

1 Medroxyprogesterone Acetate
2 Control

267 Ålborg Hospital, Denmark {Kjaer: JUN-1995}

26701 MPA Bioavailability Trial: Bioavailability Endpoint; Entry ? (26 patients were entered; not received)

1 Medroxyprogesterone Acetate [200mg sachet po] then Medroxyprogesterone Acetate [500mg tablet po]
2 Medroxyprogesterone Acetate [500mg tablet po] then Medroxyprogesterone Acetate [200mg sachet po]

268 Karolinska Institute, Danderyd, Sweden {Oddby-Muhrbeck: JUN-1995}

26801 Anaesthetic Trial: Vomiting Endpoint; Entry ? (90 patients were entered; not received)

1 Propofol [iv] + Fentanyl
2 Propofol [iv] then Isoflurane + Fentanyl
3 Thiopental [iv] then Isoflurane + Fentanyl

269 University of Manitoba, Winnipeg, Canada {Levitt: JUN-1995}

26901 Antiemetic Trial: Vomiting Endpoint; Entry ? (165 patients were entered; not received)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Ondansetron
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + Dexamethasone + Metoclopramide

270 Chinese P.L.A. General Hospital, Beijing, China {Cheng: JUN-1995}

27001 Nylestriol Trial: Postmenopausal; Biochemical and Bone Density Endpoint; Entry JAN-1989 to JUL-1992 (283 patients were entered; not received)

1 Nylestriol [2mg] × 2wk
2 Nylestriol [1mg] × 2wk
3 Control

271 Canadian National Breast Screening Study {Miller: JUN-1995}

27101 CNBSS Screening Study: Age 40-49; Entry JAN-1980 to MAR-1985 (50430 patients were entered; not received)

1 Mammography
2 Control

27102 CNBSS Screening Study: Age 50-59; Entry JAN-1980 to MAR-1985 (39405 patients were entered; not received)

1 Mammography
2 Control

272 Norwegian Breast Cancer Group {Gundersen, Hannisdal, Varhaug: JUN-2001 (SECOND REVISED VERSION, UPDATED)}

27201 89X Tamoxifen Versus Zoladex: N+; ER+/ER?; Age < 50; Entry JAN-1989 to JUL-1994 (320 patients were entered)

1 Tamoxifen [20mg/d] × 2yr
2 Goserelin [3·6mg/m²] × 2yr

27202 82H NBCG 1a (Gundersen): Stage II; Premenopausal/Postmenopausal; N+; ER+; Entry NOV-1982 to MAR-1988 (369 patients were entered)

1 Tamoxifen [10mg bd] × 2yr
2 Control

27203 89Y Megestrol Acetate Trial: N+; ER+/ER?; Age 50+; Entry MAR-1989 to DEC-1994 (489 patients were entered)

1 (Tamoxifen [20mg/d] × 8wk then Megestrol Acetate [160mg/d] × 8wk) × 2yr alternating
2 Tamoxifen [20mg/d] × 2yr

273 U.K.C.C.C.R. {Baum, Cuzick, Powles: JUN-1995}

27301 International Breast Cancer Intervention Study: Age 35-65; Double or More Normal Risk; Entry 1992 ff. (774 patients were entered by 1-APR-1995; not received)

1 Tamoxifen [20mg/d] × 5yr
2 Control

274 Anglo-Celtic Coöperative Oncology Group {Crown, Leonard: MAY-1995}

27401 95A Anglo-Celtic Group Trial (Crown, Leonard): High Risk; N10+; Entry 1995 ff. (6-10 patients were entered by MAY-1995; not received)

1 Autologous Stem Cell Transplantation
2 Doxorubicin × 4 then (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 8

27402 99A Primary Medical Therapy Trial IIA: Entry 1999 to FEB-2002 (363 patients were entered; not received)

1 Adriamycin + Docetaxel
2 Adriamycin + Cyclophosphamide

275 Hospital del Mar, Barcelona, Spain {Gallen: MAR-1996}

27501 88S Multicentric Trial: Age 60-75; N+; Postmenopausal; Radical/Modified Radical Mastectomy; Entry JAN-1988 to DEC-1994 (284 patients were entered)

1 Tamoxifen [20mg/d] × 2yr
2 Tamoxifen [20mg/d] × 4yr

276 ATLAS, U.K. {Clarke, Collins, Davies, Forster, Gray, Peto: JAN-2002 (FOURTH REVISED VERSION)}

27601 95B1 Adjuvant Tamoxifen Longer Against Shorter: Tamoxifen duration controls < 4yr; Entry DEC-1995 ff. (2342 patients were entered by SEP-2001)

1 Tamoxifen until (uncertain whether to continue)
2 Tamoxifen until (uncertain whether to continue + 5yr)

27602 95B2 Adjuvant Tamoxifen Longer Against Shorter: Tamoxifen duration controls 4+ yr; Entry DEC-1995 ff. (6329 patients were entered by OCT-2001)

1 Tamoxifen until (uncertain whether to continue)
2 Tamoxifen until (uncertain whether to continue + 5yr)

277 University of Florida, Gainesville, U.S.A. {Dragstedt: SEP-1995}

27701 58C Endocrine Ablation Trial: Stage III; Premenopausal/Postmenopausal; 7:1 Randomisation; Entry 1958 to 1968 (124 patients were entered; not received)

1 Control
2 Oöphorectomy + Adrenalectomy

278 Herlev Hospital, Copenhagen, Denmark {Herrstedt: SEP-1994}

27801 Metopimazine Trial: Chemotherapy Patients; Stage I-II; Vomiting Endpoint; Entry ? (not received)

1 Ondansetron [8mg bd] + Metopimazine [30mg qd]
2 Ondansetron [8mg bd]

279 Nihon University, Japan {Kawamori: SEP-1995}

27901 Leukocytopenia Prophylaxis Trial: Radiotherapy Patients; Haematological Endpoint; Entry ? (not received)

1 Romurutide [3/wk] × 3wk
2 Romurutide [5/wk] × 2wk

280 PRONACAM Group, Buenos Aires, Argentina {Chacon: AUG-1996}

28001 87Q1 PRONACAM 87: Premenopausal; T1-2 N1-3; Entry JUL-1987 to MAR-1993 (322 patients were entered; not received)

1 (Cyclophosphamide [600mg/m²] + Methotrexate [40mg/m²] + 5-Fluoro-Uracil [600mg/m²]) q21d × 6
2 (Cyclophosphamide [400mg/m²] + Methotrexate [30mg/m²] + 5-Fluoro-Uracil [400mg/m²] + 4-Epi-Doxorubicin [60mg/m²] + Prednisone [40mg/m² po] × 4d) q21d × 4
3 (Cyclophosphamide [400mg/m²] + Methotrexate [30mg/m²] + 5-Fluoro-Uracil [400mg/m²] + 4-Epi-Doxorubicin [60mg/m²] + Prednisone [40mg/m² po] × 4d) q21d × 6

28002 87Q2 PRONACAM 87: Premenopausal; T1-2 N4+; Entry JUL-1987 to MAR-1993 (234 patients were entered; not received)

1 (Cyclophosphamide [400mg/m²] + Methotrexate [30mg/m²] + 5-Fluoro-Uracil [400mg/m²] + 4-Epi-Doxorubicin [60mg/m²] + Prednisone [40mg/m² po] × 4d) q21d × 4
2 (Cyclophosphamide [400mg/m²] + Methotrexate [30mg/m²] + 5-Fluoro-Uracil [400mg/m²] + 4-Epi-Doxorubicin [60mg/m²] + Prednisone [40mg/m² po] × 4d) q21d × 6

28003 85Y1 PRONACAM 85(1): Age < 75; N1-3; Premenopausal; Entry 1985 to 1987 (not received)

1 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + 4-Epi-Doxorubicin

28004 85Y2 PRONACAM 85(2): Age < 75; N1-3; Postmenopausal; Entry 1985 to 1987 (not received)

1 5-Fluoro-Uracil + 4-Epi-Doxorubicin + Cyclophosphamide
2 5-Fluoro-Uracil + 4-Epi-Doxorubicin + Cyclophosphamide + Methotrexate

28005 85Y3 PRONACAM 85(3): Age < 75; N4+; Entry 1985 to 1987 (not received)

1 4-Epi-Doxorubicin + Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + P
2 Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil + 4-Epi-Doxorubicin

281 Dutch Working Party for Autologous Bone Marrow Transplant in Solid Tumours, Groningen, Netherlands {Dalesio, de Vries: JUN-2000}

28101 93V Dutch National Study: N+; Entry APR-1993 to JUL-1999 (885 patients were entered)

1 (5-Fluoro-Uracil + 4-Epi-Doxorubicin + Cyclophosphamide) × 5
2 (5-Fluoro-Uracil + 4-Epi-Doxorubicin + Cyclophosphamide) × 4 + (Cyclophosphamide + Triethylenephosphoramide + Carboplatin) × 1 then Autologous Stem Cell Transplantation

282 Yorkshire Breast Cancer Group, U.K. {: JAN-1997}

28201 86Y Yorkshire Conservation Trial: Conservative Surgery; Entry JUL-1986 to JUN-1990 (175 patients were entered; not received)

1 Radiotherapy [40Gy in 15 fractions to whole breast over 21d]
2 Radiotherapy [50-55Gy in 20 fractions to tumour bed alone]

283 Tokyo Metropolitan Komagome Hospital, Japan {Toi: SEP-2000}

28301 90B Chemotherapy Trial: Stage I-III; Entry 1990 ff. (150 patients were entered; not received)

1 (Cyclophosphamide + Methotrexate + 5-Fluoro-Uracil) × 6 + Tamoxifen × 2yr
2 5-Fluoro-Uracil [po] × 6 + Tamoxifen × 2yr

284 Bari Oncology Institute, Italy {Paradiso: JUN-2001 (UPDATED)}

28401 89@ Chemotherapy Trial: Fast-Proliferating; N-; Entry SEP-1989 to APR-1994 (244 patients were entered)

1 Control
2 (5-Fluoro-Uracil [500mg/m² d1-8] + 4-Epi-Doxorubicin [50mg/m² d1] + Cyclophosphamide [500mg/m² d1]) q21d × 6

28402 90$ Hormonotherapy Trial: Slow-Proliferating; N-; Entry 1990 to 1995 (250 patients were entered; not received)

1 Control
2 Tamoxifen [20mg/d] × 5yr

285 Istituto Oncologico Romagnolo, Forlì, Italy {Amadori: JUN-2001 (UPDATED)}

28501 89V Multi-Centre Trial: Fast-Proliferating Tumours; N-; Age < 71; Entry MAR-1989 to DEC-1993 (281 patients were entered)

1 (Cyclophosphamide [100mg/m² po d1-14] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q28d × 6
2 Control

286 Gruppo Oncologico Clinico Cooperativo del Nord Est, Italy {Galligioni: APR-2002}

28601 86S GOCCNE CMF vs. EC Trial: High Risk; pT1-3; N4+; Entry JUN-1986 to MAY-1991 (207 patients were entered)

1 (Cyclophosphamide [100mg/m² po d1-14] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q28d × 6
2 (4-Epi-Doxorubicin [120mg/m² d1] + Cyclophosphamide [600mg/m² d1]) q21d × 4

287 European Institute of Oncology, Milan, Italy {Costa, Veronesi: JAN-1999}

28701 Italian Tamoxifen Prevention Trial: Age 35-70; Hysterectomised; Entry 1992 ff. (not received)

1 Tamoxifen [20mg/d] × 5yr
2 Control

288 University of Oulu, Finland {Tomás: JUN-1999}

28801 Uterine and Vaginal Effects Trial: Postmenopausal; Entry pre-1995 (31 patients were entered; not received)

1 Tamoxifen [20mg/d]
2 Toremifene [60mg/d]

289 Finnish Breast Cancer Group {Marttunen: JUN-1999}

28901 Tamoxifen-Toremifene Trial: Stage II; N+; Postmenopausal; Entry pre-1998 (1480 patients were entered; not received)

1 Tamoxifen [20mg/d] × 3yr
2 Toremifene [40mg/d] × 3yr

290 Tampere University Hospital, Finland {Holli: MAY-1999}

29001 90M Radiotherapy Trial: Low-Risk; Conservative Surgery; N-; Age 41+; Entry 1990 to 1995 (144 patients were entered; not received)

1 Radiotherapy [50Gy in 25 fractions to whole breast and chest wall over 5wk]
2 Control

291 Kyoto Prefectural University of Medicine and Uji Hospital, Japan {Hagiwara: APR-1999}

29101 Drug Delivery Trial: Age < 70; Entry 1992 to 1995 (30 patients were entered; not received)

1 Aclarubicin [carbon-adsorbed] preoperative
2 Aclarubicin [aqueous solution] preoperative

292 Çukorova University Medical School, Adana, Turkey {Erkisi: APR-1999}

29201 85@ Bromocriptine Trial: Stage II; Premenopausal; ER+; Entry SEP-1985 to SEP-1989 (110 patients were entered; not received)

1 Radiotherapy [50Gy] + (Cyclophosphamide [100mg/m² po d1-14] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q4wk × 6 + Tamoxifen [20mg/d] × 2yr + Bromocriptine [5mg/d] × 6m
2 Radiotherapy [50Gy] + (Cyclophosphamide [100mg/m² po d1-14] + Methotrexate [40mg/m² iv d1,8] + 5-Fluoro-Uracil [600mg/m² iv d1,8]) q4wk × 6 + Tamoxifen [20mg/d] × 2yr

293 M.G.M. Medical College Cancer Hospital, Indore, India {Dvivedi: FEB-1999}

29301 75C Radiotherapy Fractionation Trial (Breast Cancer Sub-Set): Age < 65; Entry MAY-1975 to JUN-1976 (25 patients were entered; not received)

1 Radiotherapy [45Gy over 4·5wk, "conventional"]
2 Radiotherapy [6·7Gy] q1wk × 5

294 Queen Mary Hospital, Hong Kong {Alagaratnam: MAR-1999}

29401 75D1 Surgery Trial: Stage I; Entry 1975 to 1979 (20 patients were entered; not received)

1 Total Mastectomy
2 Radical Mastectomy

29402 75D2 Surgery Trial: Stage II; Entry 1975 to 1979 (75 patients were entered; not received)

1 Total Mastectomy with Axillary Node Biopsy
2 Radical Mastectomy
3 Radical Mastectomy + Radiotherapy

29403 Stage III Breast Cancer: Locally Advanced; Total Mastectomy; Postmenopausal; Entry pre-1986 (71 patients were entered; not received)

1 Radiotherapy then Tamoxifen [20mg bd] until relapse
2 Radiotherapy then (Cyclophosphamide [500mg/m² d1] + Doxorubicin [50mg/m² d1] + 5-Fluoro-Uracil [500mg/m² d1,8]) q3wk × 9-10

[End of document, updated to 27 June 2002]