UKCCCR RANDOMISED TRIAL OF ADJUVANT ENDOCRINE THERAPY AND CHEMOTHERAPY IN WOMEN WITH EARLY BREAST CANCER, THE ADJUVANT BREAST CANCER (ABC) TRIAL

OBJECTIVES: * Estimate overall and relapse-free survival of women with early-stage breast cancer receiving adjuvant tamoxifen with or without adjuvant chemotherapy and/or ovarian suppression. OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution and choice of randomization option. Postmenopausal women are randomized to the first or second groups. Randomization for pre- and perimenopausal women is based on the clinician's judgement of appropriate adjuvant therapy (chemotherapy and/or ovarian suppression). Patients may be randomized as follows: among all four groups; for chemotherapy alone (first versus second group); for ovarian suppression alone (first versus third group); for ovarian suppression with nonrandomized assignment to chemotherapy (second versus forth group); for chemotherapy with nonrandomized assignment to ovarian suppression (second versus fourth group). * First group: Patients receive tamoxifen by mouth every day for 5 years. * Second group: Patients receive tamoxifen plus cyclophosphamide, methotrexate, fluorouracil (CMF) or doxorubicin/cyclophosphamide (AC). CMF is given every month for 6 courses; AC is given every 3 weeks for 4 courses. * Third group: Patients receive tamoxifen plus ovarian suppression by oophorectomy, radiation castration, or leuprolide or goserelin. * Fourth group: Patients receive tamoxifen plus ovarian suppression plus chemotherapy with CMF or AC. Patients are followed for overall and relapse-free survival. PROJECTED ACCRUAL: Approximately 6,000 women (4,000 premenopausal, 2,000 postmenopausal) will be accrued for this study.