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Protocol B-32
A Randomized, Phase III Clinical Trial To Compare Sentinel Node Resection To Conventional Axillary Dissection In Clinically Node-Negative Breast Cancer Patients
Specific Aims
The primary aims of this phase III trial are to determine in breast cancer patients who are clinically node negative and pathologically sentinel node negative, whether sentinel node resection alone is equivalent to sentinel node resection followed by conventional axillary dissection in the long-term control of regional disease; and whether sentinel node resection alone is equivalent to sentinel node resection followed by conventional axillary dissection in regard to overall survival and disease-free survival; and whether the morbidity associated with sentinel node resection alone is significantly less than that associated with sentinel node resection followed by conventional axillary dissection. Secondary aims include determining whether in those who are sentinel node negative or sentinel node positive by pathology, the prognostic value of sentinel node resection alone is equivalent to that of sentinel node resection followed by conventional axillary dissection; and whether in those who are sentinel node negative by pathology, a more detailed pathology investigation of sentinel nodes can identify a group of patients with a potentially increased risk of systemic recurrence.
