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.
