SOLAR-1

NCT02437318 📎

Regimen

Experimental
Alpelisib 300 mg daily plus fulvestrant 500 mg.
Control
Placebo plus fulvestrant 500 mg.

Population

Men and postmenopausal women with HR+/HER2- advanced breast cancer who had progressed on prior endocrine therapy; primary cohort had PIK3CA-mutant tumors.

Key finding

SOLAR-1 established alpelisib plus fulvestrant as the first biomarker-selected targeted option (PIK3CA-mutant) in HR+/HER2- metastatic disease post-endocrine progression. Drove FDA approval May 2019 and NCCN BINV-P recommendation for PIK3CA-mutant tumors; hyperglycemia and rash drive tolerability challenges.

Source: PMID 31091374

Timeline

  • Publication: 2019 May 16

Guideline citations

  • NCCN BREAST