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Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

Study acronym: VIKTORIA-1
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 10, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study sites: 217 to 235v9
  2. Primary completion date: Jun 30, 2025 to Jun 30, 2026 Trial status: Recruiting to Active, Not Recruiting · Site details revised at 217 of 217 sitesv8 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 217 of 217 sites
  3. Primary completion date: Mar 31, 2025 to Jun 30, 2025v7
  4. Primary completion date: Sep 30, 2024 to Mar 31, 2025 Start date: Sep 30, 2022 to Dec 8, 2022 · Study sites: 218 to 217 · Completion date: Sep 30, 2026 to Dec 31, 2026v6 Show 3 more changesShow less
    • Start date: Sep 30, 2022 to Dec 8, 2022
    • Study sites: 218 to 217
    • Completion date: Sep 30, 2026 to Dec 31, 2026
  5. Study sites: 212 to 218v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 210 to 212v4
  2. Eligibility criteria shortened, about 9 words Site details revised at 9 of 210 sitesv3 Show 1 more changeShow less
    • Site details revised at 9 of 210 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 210v2 Show 1 more changeShow less
    • Study sites: 0 to 210
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.
Trial Details
NCT Number NCT05501886
Lead Sponsor Celcuity Inc
Conditions Breast Cancer
Enrollment 701 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov