{"commentary":{"count":195,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":96,"youtube":52,"podcast":43,"x_video":4},"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\": \"NCT05501886\", \"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":"VIKTORIA-1","nct_id":"NCT05501886","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=viktoria-1-nct05501886. 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":"VIKTORIA-1","arms":[{"description":"Gedatolisib + Palbociclib + Fulvestrant","label":"Arm A - Patients Lacking PIK3CA Mutations (WT)","type":"EXPERIMENTAL"},{"description":"Gedatolisib + Fulvestrant","label":"Arm B - Patients Lacking PIK3CA Mutations (WT)","type":"EXPERIMENTAL"},{"description":"Fulvestrant","label":"Arm C - Patients Lacking PIK3CA Mutations (WT)","type":"ACTIVE_COMPARATOR"},{"description":"Gedatolisib + Palbociclib + Fulvestrant","label":"Arm D - Patients with PIK3CA Mutation (MT)","type":"EXPERIMENTAL"},{"description":"Alpelisib + Fulvestrant","label":"Arm E - Patients with PIK3CA Mutation (MT)","type":"ACTIVE_COMPARATOR"},{"description":"Gedatolisib + Fulvestrant","label":"Arm F - Patients with PIK3CA Mutation (MT)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2026-12-31","type":"ESTIMATED"},"conditions":["Breast Cancer"],"enrollment":{"count":701,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Gedatolisib","type":"DRUG"},{"name":"Palbociclib","type":"DRUG"},{"name":"Fulvestrant","type":"DRUG"},{"name":"Alpelisib","type":"DRUG"}],"last_update":"2026-02-10","lead_sponsor":"Celcuity Inc","official_title":"Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2026-06-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer","timeFrame":"Approximately 48 months"}],"references":[{"citation":"Hurvitz SA, Layman RM, Curigliano G, Andre F, Cristofanilli M, Kim SB, Martinez Rodriguez JL, Nadal JC, Kim GM, Lo L, Remolina-Bonilla YA, Rosselli G, Emile G, Korbenfeld E, Puig JM, Wesolowski R, Martin M, Ring A, Han HS, Giordano A, Mutka SC, Moss K, Suzuki S, Sullivan B, Gorbatchevsky I, Pistilli B; VIKTORIA-1 Study Group. VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor-Positive/HER2-/PIK3CA Wild-Type Advanced Breast Cancer. J Clin Oncol. 2026 Apr 20;44(12):1108-1119. doi: 10.1200/JCO-25-02643. Epub 2026 Mar 9.","pmid":"41802242","type":"DERIVED"}],"start_date":{"date":"2022-12-08","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)","url":"https://clinicaltrials.gov/study/NCT05501886"},"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/viktoria-1-nct05501886"}