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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Breast Cancer Study Group
• Treatments: Tamoxifen

Criteria

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