NSABP B-31 / N9831 — Adjuvant Trastuzumab Added to Doxorubicin-Cyclophosphamide Followed by Paclitaxel in HER2-Positive Breast Cancer

Phase 3 · 2005 · Breast Cancer

Design

Joint analysis of two trials randomizing AC followed by paclitaxel with or without one year of concurrent/sequential trastuzumab.

Population

Resected HER2-positive, predominantly node-positive early breast cancer.

Primary Endpoint

disease-free survival (DFS)

Key Result

DFS HR 0.48 (halving recurrence); overall survival improved with a ~37% reduction in the risk of death.

Guideline Impact

Basis for adjuvant trastuzumab as NCCN category 1 in HER2-positive early breast cancer