NCT04762979: Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

Breast Cancer Type: HR+ & HER2-negative
Hormone Mutations: ER+, PR+
Other Mutations: PI3K
Breast Cancer Tissue: 
Recruitment Status: Recruiting
Phase 2
Drug Category: Serine-Threonine Kinase Inhibitor, Endocrine (Hormone therapy

Key Eligibility Criteria:

Gender: All
Age: 18 Years and older (Adult, Older Adult)
Location of Metastases: 
Additional Notes: Patient must have received at least one line of a CDK4/6 inhibitor and endocrine therapy (or endocrine therapy in combination with other agents) for breast cancer in the metastatic setting; Patient must also have received endocrine therapy (e.g. aromatase inhibitor or fulvestrant) as single agent or in combination with other agents as the last line of therapy with progressive disease
Exclusions: Patients with HER2+ disease including IHC as 2+ or 3+; Patients with more than two prior lines of endocrine therapy or endocrine therapy combinations in the metastatic setting (Transition from one nonsteroidal aromatase inhibitor to a second nonsteroidal aromatase inhibitor due to tolerance will only count as one line of endocrine therapy); Patients with prior chemotherapy or prior PI3K, mTOR, or AKT inhibitor for metastatic or advanced disease; Patients with active leptomeningeal disease and/or uncontrolled unstable symptomatic brain metastasis- see trial for details

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