{"entity":{"id":"nct05230810","kind":"trial","name":"Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.","aka":[],"tldr":"A phase 1/2 trial of Alpelisib, Tucatinib and Fulvestrant in HER2-positive breast cancer, run by Criterium, Inc., active and no longer recruiting.","summary":"Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer. is a phase 1/2 interventional study registered as NCT05230810 by Criterium, Inc., with 40 participants enrolled, started 2022-08-25 and due to reach its primary completion in 2026-03-30. Interventions recorded: Alpelisib, Tucatinib and Fulvestrant.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05230810","url":"https://clinicaltrials.gov/study/NCT05230810"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["alpelisib","tucatinib","fulvestrant"],"companies":["advanced-accelerator-applications","pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"nct":"NCT05230810","phase":"1/2","setting":"This is a Multicenter, Single Arm, Open-label, run-in Phase Ib / Roll-over Phase II Study of Tucatinib in Combination With Alpelisib in Subjects With PIK3CA-mutant HER2-positive Locally Advanced Unresectable or Metastatic Breast Cancer.","sponsor":"Criterium, Inc.","enrolled":40,"outcomes":[]},"route":"/trials/nct05230810/","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":"fulvestrant","kind":"drug","name":"Fulvestrant","route":"/drugs/fulvestrant/"},{"id":"tucatinib","kind":"drug","name":"Tucatinib","route":"/drugs/tucatinib/"}],"company":[{"id":"advanced-accelerator-applications","kind":"company","name":"Advanced Accelerator Applications (Novartis)","route":"/companies/advanced-accelerator-applications/"},{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}]}}