VIKTORIA-1: Gedatolisib in Advanced HR+/HER2- Breast Cancer

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Primary Completion
6/30/26
Study Completion
12/31/26
Sponsor
Celcuity Inc
Ticker
$CELC
Type
Phase 3
Trial Status
Active, not recruiting
Trial Size
701
NCT
NCT05501886
Trial Description
This is a Phase 3, open-label, randomized trial evaluating gedatolisib plus fulvestrant with or without palbociclib versus standard-of-care endocrine-based therapies in patients with locally advanced or metastatic HR+/HER2- breast cancer after progression on or after CDK4/6 inhibitor and aromatase inhibitor therapy. Patients are assigned according to confirmed PIK3CA mutation status, and the primary endpoint is progression-free survival by blinded independent central review.