Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer
Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer
RATIONALE: Removing axillary lymph nodes may be effective in stopping the spread of breast
 cancer cells. It is not yet known if surgery to remove breast cancer is more effective with
 or without lymph node removal.

 PURPOSE: Randomized phase III trial to compare the effectiveness of breast surgery with or
 without removal of axillary lymph nodes in treating women who have 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