{"commentary":{"count":225,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":114,"youtube":59,"podcast":49,"x_video":3},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04191499\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"INAVO120","nct_id":"NCT04191499","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=inavo120-nct04191499. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"INAVO120","arms":[{"description":"Participants will receive inavolisib, palbociclib, and fulvestrant.","label":"Inavolisib + Palbociclib + Fulvestrant","type":"EXPERIMENTAL"},{"description":"Participants will receive placebo, palbociclib, and fulvestrant. Participants randomized to the placebo arm who are still deriving benefit from the study treatment will be given an optional opportunity to crossover to the inavolisib arm.","label":"Placebo + Palbociclib + Fulvestrant","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2027-11-15","type":"ESTIMATED"},"conditions":["Breast Cancer"],"enrollment":{"count":325,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Inavolisib","type":"DRUG"},{"name":"Placebo","type":"DRUG"},{"name":"Palbociclib","type":"DRUG"},{"name":"Fulvestrant","type":"DRUG"}],"last_update":"2026-09-11","lead_sponsor":"Hoffmann-La Roche","official_title":"A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2023-09-29","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival (PFS)","timeFrame":"Up to 3.7 years"}],"references":[{"citation":"Jhaveri KL, Im SA, Saura C, Loibl S, Kalinsky K, Schmid P, Loi S, Thanopoulou E, Shankar N, Jin Y, Stout TJ, Clark TD, Song C, Juric D, Turner NC. Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2025 Jul 10;393(2):151-161. doi: 10.1056/NEJMoa2501796. Epub 2025 May 31.","pmid":"40454641","type":"DERIVED"},{"citation":"Turner NC, Im SA, Saura C, Juric D, Loibl S, Kalinsky K, Schmid P, Loi S, Sunpaweravong P, Musolino A, Li H, Zhang Q, Nowecki Z, Leung R, Thanopoulou E, Shankar N, Lei G, Stout TJ, Hutchinson KE, Schutzman JL, Song C, Jhaveri KL. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2024 Oct 31;391(17):1584-1596. doi: 10.1056/NEJMoa2404625.","pmid":"39476340","type":"DERIVED"}],"start_date":{"date":"2020-01-29","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer","url":"https://clinicaltrials.gov/study/NCT04191499"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/inavo120-nct04191499"}