{"entity":{"id":"paper-solar-1-alpelisib-nejm-2019","kind":"paper","name":"SOLAR-1: alpelisib plus fulvestrant for PIK3CA-mutated hormone receptor-positive advanced breast cancer","aka":[],"tldr":"Alpelisib, a pill blocking the mutated PI3K-alpha enzyme, nearly doubled the time to progression when added to fulvestrant in advanced breast cancer carrying a PIK3CA mutation, at the cost of high blood sugar and rash.","summary":"Phase 3 placebo-controlled trial of 572 patients with hormone receptor-positive, HER2-negative advanced breast cancer after an aromatase inhibitor, randomised to alpelisib or placebo with fulvestrant, stratified by PIK3CA mutation status.\n\nIn the 341 patients with PIK3CA-mutated tumours, median progression-free survival was 11.0 versus 5.7 months (hazard ratio 0.65); no benefit was seen without the mutation. Hyperglycaemia, rash and diarrhoea led to frequent dose changes.","asOf":"2026-09-17","links":[{"label":"N Engl J Med 2019","url":"https://doi.org/10.1056/NEJMoa1813904"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/31091374/"}],"tags":[],"related":[],"cancers":["hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":[],"targets":[],"drugs":["alpelisib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["solar-1"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2019,"doi":"10.1056/NEJMoa1813904","pmid":"31091374","authors":"André F, Ciruelos E, Rubovszky G, et al.","paperType":"rct","findings":["Median progression-free survival 11.0 vs 5.7 months in PIK3CA-mutated disease; hazard ratio 0.65.","Grade 3 or worse hyperglycaemia in 36.6 percent of alpelisib patients."],"whatItMeans":"PIK3CA testing became routine in advanced hormone receptor-positive breast cancer, with alpelisib-fulvestrant the first approved PI3K-targeted regimen; capivasertib and inavolisib now offer alternatives.","caveats":["Few patients had received a prior CDK4/6 inhibitor.","Toxicity leads to discontinuation in a meaningful minority."],"changedPractice":true,"participants":572},"route":"/key-papers/paper-solar-1-alpelisib-nejm-2019/","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":"alpelisib","kind":"drug","name":"Alpelisib","route":"/drugs/alpelisib/"}],"trial":[{"id":"solar-1","kind":"trial","name":"SOLAR-1","route":"/trials/solar-1/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}]}}