A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node
A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node
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:
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
Prior (preoperative) or planned (intraoperative) sentinel node biopsy required
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:
No palpable axillary lymph node(s)
No Paget's disease without invasive cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
Not pregnant or nursing
No other prior or concurrent malignancy except the following:
No psychiatric, addictive, or other disorder that may compromise ability to give informed consent
Geographically accessible for follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Westmead, New South Wales 2145, Australia