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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Jun 2026

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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

Most Recent Events

  • 18 May 2026 Planned End Date changed from 30 Dec 2028 to 30 Jul 2033.
  • 18 May 2026 Planned primary completion date changed from 31 Dec 2027 to 31 Mar 2029.
  • 14 May 2026 According to a Celcuity media release, Study 2 is expected to enroll approximately 740 subjects with treatment-naive endocrine-sensitive ABC whose cancer relapsed or progressed 12 months or more after completion of adjuvant endocrine therapy, or those with de novo metastatic disease without prior endocrine therapy exposure. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and letrozole (Arm C) compared to ribociclib combined with letrozole (Arm D).

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