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Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy

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Trial Profile

Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Jul 2025

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At a glance

  • Drugs Fulvestrant (Primary) ; Gedatolisib (Primary) ; Letrozole (Primary) ; Palbociclib (Primary) ; Alpelisib
  • Indications Advanced breast cancer; Bone metastases; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms VIKTORIA-1
  • Sponsors Celcuity

Most Recent Events

  • 24 Jun 2025 Planned primary completion date changed from 31 Mar 2025 to 30 Jun 2025.
  • 14 May 2025 According to a Celcuity media release, primary completion date for the PIK3CA wild-type patient cohort is projected to occur in June 2025 with topline data now anticipated to be available in the third quarter of 2025. Enrollment is ongoing in the PIK3CA mutant cohort remains on track to report topline data in the fourth quarter of 2025.
  • 31 Mar 2025 According to a Celcuity media release, company is on track to report topline data in Q2 2025 and topline data for the PIK3CA mutant-type cohort of the trial in Q4 2025.

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