Breast Cancer Clinical Trial
Official title:
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:
- 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.
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