Core Insights - Celcuity Inc. has initiated the Phase 3 clinical trial VIKTORIA-2 to evaluate gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant for HR+/HER2- advanced breast cancer patients who are resistant to endocrine therapy [1][2][3] Group 1: Clinical Trial Details - The VIKTORIA-2 trial is an open-label, randomized study comparing the efficacy and safety of gedatolisib combined with fulvestrant and a CDK4/6 inhibitor against the standard treatment of fulvestrant and a CDK4/6 inhibitor [3][4] - Approximately 638 subjects will be enrolled, with random assignment to either the experimental group (gedatolisib, fulvestrant, and a CDK4/6 inhibitor) or the control group (fulvestrant and a CDK4/6 inhibitor) [4] - The trial will assess primary endpoints of progression-free survival (PFS) based on RECIST 1.1 criteria, evaluated separately for PI3KCA wild type and mutant subjects [4] Group 2: Efficacy and Safety - Previous Phase 1b trial results indicated that patients receiving gedatolisib with palbociclib and letrozole had a median progression-free survival of 48.6 months and median overall survival of 77.3 months, with an objective response rate of 79% [2] - The trial aims to provide robust data to support the potential of gedatolisib as a first-line treatment option for patients with endocrine-resistant advanced breast cancer [2][3] Group 3: Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumor indications, with gedatolisib as its lead candidate [5][6] - The company is headquartered in Minneapolis and is also conducting other clinical trials, including VIKTORIA-1 and CELC-G-201, targeting different cancer types [5][6]