{"entity":{"id":"nct06757634","kind":"trial","name":"Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)","aka":[],"tldr":"A phase 3 trial of Fulvestrant, Gedatolisib, Palbociclib and Ribociclib in HR-positive / HER2-negative breast cancer, run by Celcuity Inc, now recruiting.","summary":"Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) is a phase 3 interventional study registered as NCT06757634 by Celcuity Inc, with 1180 participants planned, started 2025-07-24 and due to reach its primary completion in 2029-03-31. Interventions recorded: Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole and Arm D: Ribociclib + Letrozole.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06757634","url":"https://clinicaltrials.gov/study/NCT06757634"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["fulvestrant","gedatolisib","palbociclib","ribociclib"],"companies":["celcuity"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"nct":"NCT06757634","phase":"3","setting":"VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Gedatolisib With Endocrine Therapy and Palbociclib vs Endocrine Therapy and Ribociclib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer","sponsor":"Celcuity Inc","enrolled":1180,"outcomes":[]},"route":"/trials/nct06757634/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"drug":[{"id":"fulvestrant","kind":"drug","name":"Fulvestrant","route":"/drugs/fulvestrant/"},{"id":"gedatolisib","kind":"drug","name":"Gedatolisib","route":"/drugs/gedatolisib/"},{"id":"palbociclib","kind":"drug","name":"Palbociclib","route":"/drugs/palbociclib/"},{"id":"ribociclib","kind":"drug","name":"Ribociclib","route":"/drugs/ribociclib/"}],"company":[{"id":"celcuity","kind":"company","name":"Celcuity","route":"/companies/celcuity/"}]}}