RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combination chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without chemotherapy and/or ovarian ablation in treating women with stage I, stage II, or stage IIIA breast cancer.

OBJECTIVES: I. 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.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution and choice of randomization option. The first group receives tamoxifen by mouth every day for 5 years. The second group 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. The third group receives tamoxifen plus ovarian suppression by oophorectomy, radiation castration, or leuprolide or goserelin. The fourth group receives tamoxifen plus ovarian suppression plus chemotherapy with CMF or AC. 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). 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.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Histologically confirmed invasive carcinoma of the breast for which adjuvant systemic therapy is appropriate

• Stage I, II, or IIIA
• Pathologically positive or negative nodes
• Any size primary tumor

No edema, peau d'orange, infiltration of the skin, or direct extension to the chest wall

Hormone receptor status: Not specified

--Prior/Concurrent Therapy--

No prior systemic treatment for breast cancer

--Patient Characteristics--

Age: Not specified

Sex: Female

Menopausal status: Pre-, peri-, or postmenopausal

Performance status: Not specified

Hematopoietic: Not specified

Hepatic: Not specified

Renal: Not specified

Other: No prior malignancy except:

• Basal cell carcinoma
• Carcinoma in situ of the cervix