{"entity":{"id":"nct06790693","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer","aka":[],"tldr":"A phase 3 trial of Inavolisib 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 CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer is a phase 3 interventional study registered as NCT06790693 by Hoffmann-La Roche, with 450 participants planned, started 2025-04-09 and due to reach its primary completion in 2032-01-31. Interventions recorded: Inavolisib, Placebo, CDK4/6i and Letrozole.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06790693","url":"https://clinicaltrials.gov/study/NCT06790693"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["inavolisib"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"nct":"NCT06790693","phase":"3","setting":"A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer","sponsor":"Hoffmann-La Roche","enrolled":450,"outcomes":[]},"route":"/trials/nct06790693/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"drug":[{"id":"inavolisib","kind":"drug","name":"Inavolisib","route":"/drugs/inavolisib/"}],"company":[{"id":"flatiron-health","kind":"company","name":"Flatiron Health (Roche)","route":"/companies/flatiron-health/"}]}}