NSABP B-04

About the Trial

Bernard Fisher randomized 1,665 breast cancer patients to radical mastectomy, total mastectomy with radiation, or total mastectomy without axillary dissection, with nodes removed only if they later became positive. After 25 years of follow up there were no survival differences among the groups. The Halstedian paradigm, that breast cancer spreads in orderly fashion requiring ever wider local excision, was destroyed. Breast conserving approaches became possible. B-04, with B-06, which added lumpectomy, rewired surgical oncology toward less invasive surgery and toward systemic therapy as the driver of survival. It stands among the most consequential surgical trials ever conducted.