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