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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

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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: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Jan 2025

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At a glance

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

    • Most Recent Events

    • 07 Jan 2025 Status changed from planning to not yet recruiting.
    • 14 Nov 2024 According to a Celcuity media release, Site qualification activities to support activation of up to 200 sites across North America, Europe, Latin America, and Asia are on track.
    • 14 Aug 2024 According to a Celcuity media release, In May, the Company announced its plan to initiate VIKTORIA-2. First patient enrollment is expected in the second quarter of 2025.

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