{"entity":{"id":"nct04544189","kind":"trial","name":"Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese 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 Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer is a phase 2 interventional study registered as NCT04544189 by Novartis Pharmaceuticals, with 69 participants enrolled, started 2021-01-20 and due to reach its primary completion in 2027-01-29. Interventions recorded: Alpelisib, Fulvestrant and Placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04544189","url":"https://clinicaltrials.gov/study/NCT04544189"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["alpelisib","fulvestrant"],"companies":["advanced-accelerator-applications"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"nct":"NCT04544189","phase":"2","setting":"A Phase II Randomized Double-blind, Placebo-controlled Study of Alpelisib in Combination With Fulvestrant for Chinese Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, PIK3CA Mutant Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor (AI) Treatment, Including a Subset With Pharmacokinetic Analysis","sponsor":"Novartis Pharmaceuticals","enrolled":69,"outcomes":[]},"route":"/trials/nct04544189/","neighbours":{"cancer":[{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"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/"}]}}