{"entity":{"id":"nct05646862","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy","aka":[],"tldr":"A phase 3 trial of Inavolisib, Fulvestrant and Alpelisib in HR-positive / HER2-negative breast cancer, run by Hoffmann-La Roche, now recruiting.","summary":"A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy is a phase 3 interventional study registered as NCT05646862 by Hoffmann-La Roche, with 420 participants planned, started 2023-06-07 and due to reach its primary completion in 2026-11-13. Interventions recorded: Inavolisib, Fulvestrant, Alpelisib, Bupropion, Omeprazole and Midazolam.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05646862","url":"https://clinicaltrials.gov/study/NCT05646862"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["inavolisib","fulvestrant","alpelisib"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"nct":"NCT05646862","phase":"3","setting":"A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy","sponsor":"Hoffmann-La Roche","enrolled":420,"outcomes":[]},"route":"/trials/nct05646862/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"drug":[{"id":"alpelisib","kind":"drug","name":"Alpelisib","route":"/drugs/alpelisib/"},{"id":"fulvestrant","kind":"drug","name":"Fulvestrant","route":"/drugs/fulvestrant/"},{"id":"inavolisib","kind":"drug","name":"Inavolisib","route":"/drugs/inavolisib/"}],"company":[{"id":"flatiron-health","kind":"company","name":"Flatiron Health (Roche)","route":"/companies/flatiron-health/"}]}}