MONARCH 2 — Abemaciclib Plus Fulvestrant in HR+/HER2- Advanced Breast Cancer Progressing on Endocrine Therapy (MONARCH 2)

Phase 3 · 2017 · Breast Cancer

Design

Randomized, double-blind trial of abemaciclib plus fulvestrant vs placebo plus fulvestrant.

Population

HR+/HER2- advanced breast cancer that progressed on prior endocrine therapy.

Primary Endpoint

progression-free survival (PFS)

Key Result

Median PFS 16.4 vs 9.3 mo (HR 0.553); median OS 46.7 vs 37.3 mo (HR 0.757, P=0.01).

Guideline Impact

NCCN category 1 abemaciclib + fulvestrant for HR+/HER2- advanced breast cancer after endocrine therapy