CLEOPATRA — Clinical Evaluation of Pertuzumab and Trastuzumab: Pertuzumab, Trastuzumab, and Docetaxel in HER2-Positive Metastatic Breast Cancer

Phase 3 · 2012 · Breast Cancer

Design

Randomized 1:1 to pertuzumab plus trastuzumab plus docetaxel vs placebo plus trastuzumab plus docetaxel as first-line therapy.

Population

HER2-positive metastatic breast cancer with no prior therapy for metastatic disease.

Primary Endpoint

progression-free survival (PFS)

Key Result

Median PFS 18.7 vs 12.4 mo (HR 0.68); median OS 57.1 vs 40.8 mo (HR 0.69), an unprecedented ~16-mo OS gain.

Guideline Impact

NCCN category 1 first-line HER2-positive MBC