MONALEESA-7 — Ribociclib Plus Endocrine Therapy in Premenopausal HR+/HER2- Advanced Breast Cancer (MONALEESA-7)

Phase 3 · 2018 · Breast Cancer

Design

Randomized, double-blind trial of ribociclib plus endocrine therapy (tamoxifen or a nonsteroidal aromatase inhibitor) plus goserelin vs placebo plus the same endocrine backbone.

Population

Premenopausal women with HR+/HER2- advanced breast cancer, endocrine-therapy naive for advanced disease.

Primary Endpoint

progression-free survival (PFS)

Key Result

Median PFS 23.8 vs 13.0 mo (HR 0.55); 42-month OS 70.2% vs 46.0% (HR 0.71, P=0.00973).

Guideline Impact

NCCN category 1 first-line CDK4/6 inhibitor plus endocrine therapy for premenopausal HR+/HER2- advanced breast cancer