MONALEESA-3 — Ribociclib Plus Fulvestrant in Postmenopausal HR+/HER2- Advanced Breast Cancer (MONALEESA-3)

Phase 3 · 2018 · Breast Cancer

Design

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

Population

Postmenopausal women and men with HR+/HER2- advanced breast cancer, treatment-naive or with up to one prior line of endocrine therapy.

Primary Endpoint

progression-free survival (PFS)

Key Result

Median PFS 20.5 vs 12.8 mo (HR 0.593); median OS 53.7 vs 41.5 mo (HR 0.726, P=0.00455).

Guideline Impact

NCCN category 1 ribociclib + fulvestrant for HR+/HER2- advanced breast cancer