A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy (VIKTORIA-1)
Categories (click each to see list of all clinical trials associated with that category): Breast (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Krishnamurthy, Jairam
Eligibility: https://clinicaltrials.gov/study/NCT05501886?term=NCT05501886&rank=1
Summary
Primary Objective: To compare the efficacy, as measured by progression-free survival (PFS), of gedatolisib in combination with palbociclib and fulvestrant (Arm A) to fulvestrant (Arm C) in adults with HR+/HER2-/PIK3CA wild type (WT) advanced breast cancer whose disease has progressed on prior CDK4/6 therapy in combination with non-steroidal aromatase inhibitor (AI) therapy To compare efficacy, as measured by PFS, of gedatolisib in combination with fulvestrant (Arm B) to Arm C in adults with HR+/HER2-/PIK3CA WT advanced breast cancer whose disease has progressed on prior CDK4/6 therapy in combination with non-steroidal AI therapy. To compare the
efficacy, as measured by PFS, of gedatolisib in combination with palbociclib and fulvestrant (Arm D) to alpelisib with fulvestrant (Arm E) in adults with HR+/HER2-/PIK3CA mutated (MT) advanced breast cancer whose disease has progressed on prior CDK4/6 therapy in combination with non-steroidal AI therapy Secondary Objectives: To compare the efficacy, as measured by PFS, of Arm A to Arm B in adults with HR+/HER2-/PIK3CA WT advanced breast cancer whose disease has progressed on prior CDK4/6 therapy in
combination with non-steroidal AI therapy To compare the efficacy, as measured by overall survival (OS), of Arm A to Arm C, Arm B to Arm C, and Arm A to Arm B. To compare safety and tolerability between the treatment arms. Evaluate the contributory treatment effect of gedatolisib, palbociclib, and the combined treatment effect of gedatolisib and palbociclib in the stratified Cox proportional hazard model. To compare the efficacy, as measured by overall response rate (ORR); duration of response (DOR); time to response (TTR); and clinical benefit rate (CBR), of Arm A to Arm C, Arm B to Arm C, and Arm A to Arm B. To compare change in health status/quality of life (QOL) of
Arm A to Arm C, Arm B to Arm C, and Arm A to Arm B. Pharmacokinetics (PK) of gedatolisib. To compare the efficacy, as measured by PFS, of Arm D to gedatolisib in combination with fulvestrant (Arm F) in adults with HR+/HER2-/PIK3CA MT advanced breast cancer whose disease has progressed on prior CDK4/6 therapy in combination with nonsteroidal AI therapy. To compare the efficacy, as measured by OS, of Arm D to Arm E in adults with HR+/HER2-/PIK3CA MT advanced breast cancer whose disease has progressed on prior CDK4/6 therapy. To compare the efficacy, as measured by OS, of Arm D to Arm F in adults with HR+/HER2-/PIK3CA MT advanced breast cancer whose disease has progressed on prior CDK4/6 therapy in combination with non-steroidal AI therapy. To compare safety and tolerability between the treatment arms. To compare the efficacy, as measured by PFS, of Arm E to Arm F in adults with HR+/HER2-/PIK3CA MT advanced breast cancer whose disease has progressed on prior CDK4/6 therapy in combination with nonsteroidal AI therapy. To compare the efficacy, as measured by ORR, DOR, TTR, and CBR, of Arm D to Arm E. To compare change in health status/QOL of Arm D to Arm E. Pharmacokinetics (PK) of gedatolisib.
Exploratory Objectives: Biomarkers of efficacy, mode-of-action-related effect, safety, and/or pathomechanism of the disease (optional). To compare the efficacy of Arm A to Arm C, Arm B to Arm C, and Arm A to Arm B as assessed by investigators. Biomarkers of efficacy, mode-of-action-related effect, safety, and/or pathomechanism of the disease (optional). To compare the efficacy of Arm D to Arm E, as assessed by investigators.