Trial Profile

VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 13 Aug 2025

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At a glance

Drugs Fulvestrant (Primary) ; Gedatolisib (Primary) ; Palbociclib (Primary) ; Ribociclib (Primary)
Indications Advanced breast cancer; HER2 negative breast cancer; HER2 positive breast cancer
Focus Registrational; Therapeutic Use
Acronyms VIKTORIA-2
Sponsors Celcuity

24 Jul 2025 According to a Celcuity media release, First patient has been dosed in this trial.
18 Jun 2025 Status changed from not yet recruiting to recruiting.
30 Apr 2025 Trial design presented at the 116th Annual Meeting of the American Association for Cancer Research.

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