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

• Status: Recruiting
• Trial end date: 2026-09-30

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.

Condition or disease:

Breast Cancer

Intervention/treatment:

Drug: Gedatolisib

Drug: Palbociclib

Drug: Fulvestrant

Drug: Alpelisib

Phase 3

• Phase: Phase 3

Details

• Lead Sponsor: Celcuity, Inc.
• Treatments: Fulvestrant; Gedatolisib; Palbociclib