Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer

OBJECTIVES:

• Compare local and systemic disease-free survival, ipsilateral axillary relapse, occurrence of postmastectomy syndrome, and overall survival of elderly women with clinically operable stage I or IIA breast cancer who subsequently receive adjuvant tamoxifen after treatment with breast surgery with or without axillary node dissection.
• Compare the toxicity of these regimens in these patients.
• Compare the quality of life in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to whether they received prior primary surgery (yes vs no) and participating center.

• Arm I: Patients undergo mastectomy, lumpectomy, or quadrantectomy with axillary clearance. Patients then receive oral tamoxifen for 5 years. Patients may also undergo sentinel node biopsy.
• Arm II: Patients undergo surgery as in arm I without axillary clearance. Patients then receive oral tamoxifen for 5 years.

Patients in both arms who undergo breast-conserving surgery may receive optional radiotherapy for 5-6 weeks to the remaining breast tissue, chest, and lung. Upon recurrence in the conserved breast, patients undergo total mastectomy; those in arm II who experience ipsilateral axillary recurrence undergo surgical excision. Adjuvant tamoxifen and follow up are continued.

Quality of life is assessed.

Patients are followed every 3 months for 1 year, every 6 months while receiving tamoxifen, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,020 patients will be accrued for this study within approximately 5 years.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed stage I or IIA breast carcinoma that is considered operable
• No prior axillary clearance or biopsy
• Complete excisional biopsy of primary tumor without axillary clearance or biopsy allowed
• Suspicious manifestations of metastatic disease (e.g., hot spots on bone scan or skeletal pain of unknown cause) must be proven benign
• No bilateral breast cancer (any mass in contralateral breast must be proven benign by biopsy)
• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 60 and over

Sex:

• Female

Menopausal status

• Postmenopausal

Performance status:

• Not specified

Hematopoietic:

• WBC greater than 4,000/mm^3
• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin less than 1.1 mg/dL
• AST less than 60 U/L

Renal:

• Creatinine less than 1.3 mg/dL

Cardiovascular:

• Normal cardiac function
• No history of congestive heart failure

Other:

• No nonmalignant systemic disease that would preclude protocol therapy or prolonged follow-up
• No psychiatric or addictive disorder that would preclude protocol therapy or informed consent
• No other prior or concurrent malignancy except nonmelanomatous skin cancer or adequately treated carcinoma in situ of the cervix
• Geographically accessible for follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic therapy for breast cancer

Chemotherapy:

• No prior chemotherapy for breast cancer

Endocrine therapy:

• No prior endocrine therapy for breast cancer

Radiotherapy:

• No prior radiotherapy for breast cancer

Surgery:

• See Disease Characteristics