A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node
- Compare disease-free survival of women with clinically node-negative breast cancer with
sentinel lymph node micrometastases treated with surgical resection with or without
- Compare overall survival of patients treated with these regimens.
- Compare the incidence of reappearance of disease in the undissected axilla, sites of
first failure, and short- and long-term surgical complications in patients treated with
- Correlate pathological features of disease with outcome in patients treated with these
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 randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo surgical resection of the primary tumor with axillary lymph
- Arm II: Patients undergo surgical resection of the primary tumor without axillary lymph
Patients in both arms may receive adjuvant therapy based on biological factors determined on
the primary tumor or subsequent disease recurrence.
Patients are followed every 4 months for 1 year, every 6 months for 4 years, and then
PROJECTED ACCRUAL: Approximately 1,960 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Viviana E. Galimberti
European Institute of Oncology
United States: Federal Government