APHINITY — Adjuvant Pertuzumab and Herceptin in Initial Therapy of Breast Cancer

Phase 3 · 2017 · Breast Cancer

Design

Randomized 1:1 to adjuvant chemotherapy plus trastuzumab plus pertuzumab vs plus placebo after surgery.

Population

Operable HER2-positive early breast cancer, enriched for node-positive/high-risk disease.

Primary Endpoint

invasive disease-free survival (iDFS)

Key Result

6-yr iDFS 90.6% vs 87.8% (HR 0.76); benefit concentrated in node-positive disease (6-yr iDFS 87.9% vs 83.4%).

Guideline Impact

NCCN option for adjuvant node-positive HER2-positive disease