CAPItello-291

NCT04305496 📎

Regimen

Experimental
Capivasertib 400 mg BID (4 days on, 3 days off) plus fulvestrant 500 mg.
Control
Placebo plus fulvestrant 500 mg.

Population

Men and women with HR+/HER2- advanced breast cancer who had progressed on or after AI-based therapy, with prior CDK4/6 exposure permitted; defined molecular (AKT-pathway-altered: PIK3CA/AKT1/PTEN) subgroup.

Key finding

CAPItello-291 established capivasertib plus fulvestrant as a new standard of care for HR+/HER2- advanced disease with AKT-pathway alterations (PIK3CA, AKT1, or PTEN). FDA approved November 2023 for the AKT-altered subset; NCCN BINV-P recommends biomarker-directed use.

Source: PMID 37256976

Timeline

  • Publication: 2023 Jun 1

Guideline citations

  • NCCN BREAST