{"entity":{"id":"nct05501886","kind":"trial","name":"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)","aka":["VIKTORIA-1"],"tldr":"A phase 3 trial of Gedatolisib, Palbociclib, Fulvestrant and Alpelisib in advanced solid tumours, run by Celcuity Inc, active and no longer recruiting.","summary":"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) is a phase 3 interventional study registered as NCT05501886 by Celcuity Inc, with 701 participants enrolled, started 2022-12-08 and due to reach its primary completion in 2026-06-30. Interventions recorded: Gedatolisib, Palbociclib, Fulvestrant and Alpelisib.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05501886","url":"https://clinicaltrials.gov/study/NCT05501886"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy","kinase-inhibitors"],"targets":[],"drugs":["gedatolisib","palbociclib","fulvestrant","alpelisib"],"companies":["celcuity"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05501886","phase":"3","setting":"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","sponsor":"Celcuity Inc","started":"2022-12-08","startedType":"actual","enrolled":701,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05501886/","neighbours":{"cancer":[{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"technology":[{"id":"cdk46-inhibitor","kind":"technology","name":"CDK4/6 inhibitors","route":"/technologies/cdk46-inhibitor/"},{"id":"endocrine-therapy","kind":"technology","name":"Endocrine therapy (SERMs, AIs, SERDs)","route":"/technologies/endocrine-therapy/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"alpelisib","kind":"drug","name":"Alpelisib","route":"/drugs/alpelisib/"},{"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/"}],"company":[{"id":"celcuity","kind":"company","name":"Celcuity","route":"/companies/celcuity/"}]}}