{"entity":{"id":"nct04208178","kind":"trial","name":"Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation","aka":[],"tldr":"A phase 3 trial of Alpelisib, Trastuzumab and Pertuzumab in HER2-positive breast cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation is a phase 3 interventional study registered as NCT04208178 by Novartis Pharmaceuticals, with 19 participants enrolled, started 2020-07-16 and due to reach its primary completion in 2027-02-26. Interventions recorded: Alpelisib, Alpelisib matching Placebo, Trastuzumab and Pertuzumab.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04208178","url":"https://clinicaltrials.gov/study/NCT04208178"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["alpelisib","trastuzumab","pertuzumab"],"companies":["advanced-accelerator-applications"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"nct":"NCT04208178","phase":"3","setting":"EPIK-B2: A Two Part, Phase III, Multicenter, Randomized (1:1), Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation","sponsor":"Novartis Pharmaceuticals","enrolled":19,"outcomes":[]},"route":"/trials/nct04208178/","neighbours":{"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"}],"drug":[{"id":"alpelisib","kind":"drug","name":"Alpelisib","route":"/drugs/alpelisib/"},{"id":"pertuzumab","kind":"drug","name":"Pertuzumab","route":"/drugs/pertuzumab/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"}],"company":[{"id":"advanced-accelerator-applications","kind":"company","name":"Advanced Accelerator Applications (Novartis)","route":"/companies/advanced-accelerator-applications/"}]}}