SOLAR-1 — Alpelisib Plus Fulvestrant in PIK3CA-Mutated HR+/HER2- Advanced Breast Cancer (SOLAR-1)

Phase 3 · 2019 · Breast Cancer

Design

Randomized, double-blind trial of alpelisib plus fulvestrant vs placebo plus fulvestrant, stratified by PIK3CA mutation status.

Population

HR+/HER2- advanced breast cancer progressing on or after aromatase inhibitor therapy; the PIK3CA-mutated cohort was the primary population.

Primary Endpoint

progression-free survival (PFS) in the PIK3CA-mutated cohort

Key Result

In PIK3CA-mutated disease, median PFS 11.0 vs 5.7 mo (HR 0.65, P<0.001).

Guideline Impact

FDA-approved 2019; NCCN-listed for PIK3CA-mutated HR+/HER2- advanced breast cancer after endocrine therapy