{"entity":{"id":"paper-capitello-291-nejm-2023","kind":"paper","name":"CAPItello-291: capivasertib plus fulvestrant in hormone receptor-positive advanced breast cancer","aka":[],"tldr":"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.","summary":"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.\n\nMedian 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.","asOf":"2026-09-17","links":[{"label":"N Engl J Med 2023","url":"https://doi.org/10.1056/NEJMoa2214131"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/37256976/"}],"tags":[],"related":[],"cancers":["hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":[],"targets":[],"drugs":["capivasertib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["capitello-291"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2023,"doi":"10.1056/NEJMoa2214131","pmid":"37256976","authors":"Turner NC, Oliveira M, Howell SJ, et al.","paperType":"rct","findings":["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."],"whatItMeans":"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.","caveats":["Approval was limited to pathway-altered tumours because benefit in non-altered disease was uncertain.","Overall survival data were immature."],"changedPractice":true,"participants":708},"route":"/key-papers/paper-capitello-291-nejm-2023/","neighbours":{"cancer":[{"id":"hr-positive-metastatic-post-cdk46","kind":"cancer","name":"HR-positive metastatic breast cancer after CDK4/6 inhibitors","route":"/cancers/hr-positive-metastatic-post-cdk46/"}],"drug":[{"id":"capivasertib","kind":"drug","name":"Capivasertib","route":"/drugs/capivasertib/"}],"trial":[{"id":"capitello-291","kind":"trial","name":"CAPItello-291","route":"/trials/capitello-291/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}]}}