{"entity":{"id":"nct05038735","kind":"trial","name":"Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.","aka":["EPIK-B5"],"tldr":"A phase 3 trial of Alpelisib and Fulvestrant in HR-positive / HER2-negative breast cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. is a phase 3 interventional study registered as NCT05038735 by Novartis Pharmaceuticals, with 210 participants enrolled, started 2021-12-17 and due to reach its primary completion in 2027-01-28. Interventions recorded: Alpelisib, Fulvestrant and Alpelisib-matching placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05038735","url":"https://clinicaltrials.gov/study/NCT05038735"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["endocrine-therapy","kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["alpelisib","fulvestrant"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05038735","phase":"3","setting":"EPIK-B5: A Phase III, Randomized, Double-blind, Placebo-controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With HR-positive, HER2-negative Advanced Breast Cancer With a PIK3CA Mutation, Who Progressed on or After Aromatase Inhibitor and a CDK4/6 Inhibitor","sponsor":"Novartis Pharmaceuticals","started":"2021-12-17","startedType":"actual","enrolled":210,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05038735/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"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/"}],"technology":[{"id":"endocrine-therapy","kind":"technology","name":"Endocrine therapy (SERMs, AIs, SERDs)","route":"/technologies/endocrine-therapy/"},{"id":"pi3k-akt-mtor-inhibitors","kind":"technology","name":"PI3K, AKT and mTOR inhibitors","route":"/technologies/pi3k-akt-mtor-inhibitors/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"alpelisib","kind":"drug","name":"Alpelisib","route":"/drugs/alpelisib/"},{"id":"fulvestrant","kind":"drug","name":"Fulvestrant","route":"/drugs/fulvestrant/"}],"company":[{"id":"advanced-accelerator-applications","kind":"company","name":"Advanced Accelerator Applications (Novartis)","route":"/companies/advanced-accelerator-applications/"},{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}]}}