A Phase III, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy
Details
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.
Eligibility
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Key Inclusion Criteria
-Patients must be at least 18 years of age.
-Negative pregnancy test for women of childbearing potential. Female subjects of childbearing potential must use an effective and/or acceptable contraceptive method from screening until 1 year after the last dose of study treatment.
-Patients must have histologically or cytologically confirmed diagnosis of metastatic or locally advanced breast cancer.
Key Exclusion Criteria
-Patients with prior treatment with chemotherapy and antibody drug conjugates (e.g., Enhertu) for advanced disease
-Patients with bone only disease that is only blastic with no soft tissue component
-Patients with type 1 diabetes or uncontrolled type 2 diabetes