{"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":["INAVO123"],"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":["kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["inavolisib"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"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","participation":[{"nct":"NCT06790693","source":"https://clinicaltrials.gov/study/NCT06790693","fetchedAt":"2026-10-07T16:55:03.017Z","studySha256":"607e4b3ae534966e96a5e7ba0a91b4834430e227e0f48c8c7a63bc277df674f0","overallStatus":"RECRUITING","lastUpdatePosted":"2026-10-06","leadSponsor":"Hoffmann-La Roche","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":450,"enrolmentType":"ESTIMATED","siteCount":242,"recruitingSiteCount":240,"countries":["Argentina","Australia","Brazil","Canada","China","France","Germany","Italy","Japan","Mexico","Poland","Puerto Rico","South Africa","South Korea","Spain","Switzerland","Taiwan","Turkey (Türkiye)","United Kingdom","United States"]}],"started":"2025-04-09","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06790693/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"technology":[{"id":"pi3k-akt-mtor-inhibitors","kind":"technology","name":"PI3K, AKT and mTOR inhibitors","route":"/technologies/pi3k-akt-mtor-inhibitors/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"inavolisib","kind":"drug","name":"Inavolisib","route":"/drugs/inavolisib/"}],"company":[{"id":"flatiron-health","kind":"company","name":"Flatiron Health (Roche)","route":"/companies/flatiron-health/"}]}}