Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.

Trial Details

NCT ID
NCT06757634
Phase
PHASE3
Sponsor
Celcuity Inc
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant
  • Arm B: Palbociclib or Ribociclib + Fulvestrant
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Fullerton, California, United States|33.87029,-117.92534
  • Los Angeles, California, United States|34.05223,-118.24368
  • Plantation, Florida, United States|26.13421,-80.23184
  • Tamarac, Florida, United States|26.21286,-80.24977

Key Eligibility Criteria

  • Histologically or cytologically confirmed diagnosis of metastatic or locally advanced HR+/HER2- breast cancer
  • Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment wi…
  • Negative pregnancy test for females of childbearing potential. Female subjects who are not surgically sterile must use a medically effective contra…
  • Progression of disease during or within 12 months of completing (neo)adjuvant endocrine therapy (ET) or progression of disease after 12 months of c…

For full eligibility, visit ClinicalTrials.gov.

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