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 Summary

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.

Conditions

Breast Cancer

Interventions / Drugs

Gedatolisib Palbociclib Fulvestrant Alpelisib

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment701 participants

Primary Completion—

Lead SponsorCelcuity Inc

Data Retrieved2026-04-11 04:09:11.213935+00:00

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