Why perform randomized clinical trials for sentinel node surgery for breast cancer?

Long-term outcome of sentinel node surgery without axillary dissection has not been established. To that extent the therapeutic outcome of sentinel node surgery is unknown. Two important clinical trials are under way that are designed to compare sentinel node surgery without axillary dissection to axillary dissection. In partnership with the University of Vermont, the National Surgical Adjuvant Breast and Bowel Project is conducting a trial that will primarily compare node negative breast cancer cases. The American College of Surgeons Clinical Oncology Group is conducting a trial that randomizes node positive breast cancer patients. The primary endpoints of these clinical trials are survival, long-term regional control, and morbidity. At the conclusion of these trials it will be established within a narrow confidence interval whether sentinel node surgery alone provides the same important therapeutic benefits as axillary surgery but without the morbidity associated with axillary surgery.