MONALEESA-2 — Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer (MONALEESA-2)

Phase 3 · 2016 · Breast Cancer

Design

Randomized double-blind trial of ribociclib plus letrozole versus placebo plus letrozole as first-line therapy.

Population

Postmenopausal women with HR-positive, HER2-negative recurrent or metastatic breast cancer, no prior therapy for advanced disease.

Primary Endpoint

progression-free survival (PFS)

Key Result

PFS 25.3 vs 16.0 months (HR 0.57); final overall survival 63.9 vs 51.4 months (HR 0.76), the first CDK4/6 inhibitor trial to show a median OS >5 years in the first-line setting.

Guideline Impact

NCCN category 1 first-line CDK4/6 inhibitor plus aromatase inhibitor for HR+/HER2- metastatic breast cancer