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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
931
Axillary lymph node dissection
Therapeutic conventional surgery
Lismore Base Hospital
Lismore, New South Wales, Australia
St Vincents Hospital
Lismore, New South Wales, Australia
Mater Hospital - North Sydney
North Sydney, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
5-year Disease-Free Survival
Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to first evidence of invasive relapse at any site, second primary tumor (contralateral or non-breast) or death.
Time frame: 5-year estimate reported after a median follow-up of 60 months
5-year Overall Survival
Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death of any cause.
Time frame: 5-year estimate reported after a median follow-up of 60 months
Site of Recurrence
Site of recurrence of breast cancer
Time frame: Reported after a median follow-up of 60 months
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