PALOMA-2 — Palbociclib (PD-0332991) Combined With Letrozole Versus Letrozole for First-Line Treatment of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

Phase 3 · 2016 · Breast Cancer

Design

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

Population

Postmenopausal women with ER-positive, HER2-negative advanced breast cancer with no prior systemic treatment for advanced disease.

Primary Endpoint

progression-free survival (PFS)

Key Result

PFS 24.8 vs 14.5 months (HR 0.58); overall survival was not significantly improved (53.9 vs 51.2 months).

Guideline Impact

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