NSABP B-04

Clinical Question

In patients with invasive breast cancer, does less extensive surgery (vs Halsted radical mastectomy) lead to equivalent outcomes?

Bottom Line

The modern total (simple) mastectomy provides equivalent oncologic outcomes to the radical mastectomy with regards to the breast.

Major Points

Radical mastectomy was not superior to simple mastectomy. This trial also evaluated axillary management and found that, for clinically node negative patients, radiotherapy (RT) was superior to axillary lymph node dissection (ALND) or no axillary management. There was no benefit to ALND vs RT for clinically node positive patients.

Design

• Multicenter, double-blind, parallel-group, randomized, controlled trial
• N=

• Setting: xx centers in Canada* and the United States
• Enrollment: <dates>
• Mean follow-up:
• Analysis: Intention-to-treat
• Primary outcome:

Population

Baseline Characteristics

• Mean age:
• T stage distribution: