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.
1 Primary · 10 Secondary · Reporting Duration: Approximately 48 months
701 Total Participants · 6 Treatment Groups
Primary Treatment: Arm A - Patients Lacking PIK3CA Mutations (WT) · No Placebo Group · Phase 3
Age 18+ · All Participants · 10 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
|18 - 65||100.0%|
|Virginia Cancer Institute||100.0%|