Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node
 micrometastases may remove cancer cells that have spread from tumors in the breast. It is not
 yet known whether surgery to remove the primary tumor is more effective with or without
 axillary lymph node dissection.

 PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node
 dissection to see how well they work compared to surgery alone in treating women with
 node-negative breast cancer and sentinel lymph node micrometastases.
OBJECTIVES:

 -  Compare disease-free survival of women with clinically node-negative breast cancer with
 sentinel lymph node micrometastases treated with surgical resection with or without
 axillary dissection.

 -  Compare overall survival of patients treated with these regimens.

 -  Assess sites of recurrence, particularly reappearance of disease in the undissected
 axilla.

 -  Assess long-term surgical complications in patients treated with these regimens.

 OUTLINE: This is a multicenter study. Patients are stratified according to participating
 center, menopausal status (pre- vs postmenopausal), and preoperative sentinel node biopsy
 (yes vs no). Patients are followed every 4 months for 1 year, every 6 months for 4 years, and
 then annually thereafter.
DISEASE CHARACTERISTICS:

 -  Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and
 unifocal breast carcinoma

 -  Largest tumor lesion ≤ 5 cm

 -  Palpable or nonpalpable breast lesion

 -  Preoperative radioactive occult lesion localization, hook wire, or other method
 of localization required for nonpalpable lesions

 -  Prior (preoperative) or planned (intraoperative) sentinel node biopsy required

 -  At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with
 no extracapsular extension

 -  No clinical evidence of distant metastases

 -  No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI,
 or CT scan, including the following:

 -  Skeletal pain of unknown cause

 -  Elevated alkaline phosphatase

 -  Bone scan showing hot spots

 -  No palpable axillary lymph node(s)

 -  No Paget's disease without invasive cancer

 -  Hormone receptor status:

 -  Estrogen receptor and progesterone receptor known

 PATIENT CHARACTERISTICS:

 Age

 -  Any age

 Sex

 -  Female

 Menopausal status

 -  Any status

 Performance status

 -  Not specified

 Life expectancy

 -  Not specified

 Hematopoietic

 -  Not specified

 Hepatic

 -  See Disease Characteristics

 Renal

 -  Not specified

 Other

 -  Not pregnant or nursing

 -  No other prior or concurrent malignancy except the following:

 -  Adequately treated basal cell or squamous cell skin cancer

 -  Adequately treated carcinoma in situ of the cervix

 -  Adequately treated in situ melanoma

 -  Contralateral or ipsilateral carcinoma in situ of the breast

 -  No psychiatric, addictive, or other disorder that may compromise ability to give
 informed consent

 -  Geographically accessible for follow-up

 PRIOR CONCURRENT THERAPY:

 Biologic therapy

 -  Not specified

 Chemotherapy

 -  Not specified

 Endocrine therapy

 -  Not specified

 Radiotherapy

 -  Not specified

 Surgery

 -  See Disease Characteristics

 Other

 -  No prior systemic therapy for breast cancer

 -  More than 1 year since prior chemopreventive agent