{"entity":{"id":"nct04524000","kind":"trial","name":"Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer","aka":[],"tldr":"A phase 2 trial of Alpelisib and Fulvestrant in advanced solid tumours, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer is a phase 2 interventional study registered as NCT04524000 by Novartis Pharmaceuticals, with 24 participants enrolled, started 2021-01-08 and due to reach its primary completion in 2027-02-26. Interventions recorded: Alpelisib and Fulvestrant.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04524000","url":"https://clinicaltrials.gov/study/NCT04524000"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"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":"NCT04524000","phase":"2","setting":"A Phase II Open-label, 2-Part, Multi-center Study of BYL719 (Alpelisib) in Combination With Fulvestrant for Men and Postmenopausal Women With PIK3CA Mutation Hormone Receptor (HR) Positive, HER2-negative, Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor (AI) Treatment in Japan","sponsor":"Novartis Pharmaceuticals","started":"2021-01-08","startedType":"actual","enrolled":24,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct04524000/","neighbours":{"cancer":[{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"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/"}]}}