Phase 3Recruiting
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
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 (Industry)
- Enrolment
- 1,180 planned
- Conditions
- Breast Cancer
- Interventions
- Arm A: Gedatolisib + Palbociclib + Fulvestrant; Arm B: Ribociclib + Fulvestrant; Arm C: Gedatolisib + Palbociclib + Letrozole; Arm D: Ribociclib + Letrozole
- Ages
- adults, older adults
- Registry
- NCT06757634
Full record on ClinicalTrials.gov
From the registry
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.
Primary outcomes
- Progression Free Survival (PFS)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered