PALOMA-3 — Palbociclib Plus Fulvestrant in HR+/HER2- Metastatic Breast Cancer Progressing on Endocrine Therapy (PALOMA-3)

Phase 3 · 2015 · Breast Cancer

Design

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

Population

HR+/HER2- metastatic breast cancer that progressed on prior endocrine therapy (pre-, peri-, or postmenopausal).

Primary Endpoint

progression-free survival (PFS)

Key Result

Median PFS 9.5 vs 4.6 mo (HR 0.46); median OS 34.9 vs 28.0 mo (HR 0.81) with a pronounced benefit in endocrine-sensitive disease.

Guideline Impact

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