CAPItello-291: capivasertib plus fulvestrant in hormone receptor-positive advanced breast cancer
Adding the AKT inhibitor capivasertib to fulvestrant doubled the time to progression in advanced hormone receptor-positive breast cancer after aromatase inhibitor failure, with the largest gain in tumours with PIK3CA, AKT1 or PTEN alterations.
Overview
Phase 3 placebo-controlled trial of 708 patients with hormone receptor-positive, HER2-negative advanced breast cancer that had relapsed or progressed on an aromatase inhibitor, about 70 percent after a CDK4/6 inhibitor, randomised to capivasertib or placebo with fulvestrant.
Median progression-free survival was 7.2 versus 3.6 months overall (hazard ratio 0.60) and 7.3 versus 3.1 months in the AKT pathway-altered population (hazard ratio 0.50). Diarrhoea, rash and hyperglycaemia were the main toxicities.
- Median progression-free survival 7.2 vs 3.6 months overall; hazard ratio 0.60.
- AKT pathway-altered: 7.3 vs 3.1 months; hazard ratio 0.50.
Capivasertib-fulvestrant is a standard option for tumours with PIK3CA, AKT1 or PTEN alterations after a CDK4/6 inhibitor, adding a second targeted pathway to endocrine therapy.
- Approval was limited to pathway-altered tumours because benefit in non-altered disease was uncertain.
- Overall survival data were immature.
Similar pages
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- TargetAKT
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