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Clinical Research & Trials

uso 21205

A Phase II, Multicenter, Randomized, Open-Label, Active-Controlled Study To Assess The Safety And Efficacy Of Dapagliflozin + Metformin XR Versus Metformin XR During Treatment With Alpelisib (BYL719) In Combination With Fulvestrant In Participants With HR+, HER2-, Advanced Breast Cancer With A PIK3CA Mutation Following Progression On/After Endocrine-Based Therapy ( EPIK-B4):(CBYL719C2202)


Disease Types: Breast Cancer Research

Eligibility Requirements:

Hormone receptor positive and HER 2 negative advanced breast cancer with PIK3CA mutation that has progressed on endocrine therapy 
-Have one of the following – considered pre-diabetic or diabetic (elevated fasting plasma glucose, HbA1c), BMI ≥ 30, or Age ≥ 75 yrs
-No: pre-menopausal; ineligible for endocrine therapy due to disease burden; more than 1 line of treatment in metastatic setting; inflammatory breast cancer; diabetes type I or II requiring 
 anti-hyperglycemic therapy; GI disorder or condition that alters absorption of oral medication; acute pancreatitis within 1 year of screening or history of chronic pancreatitis; pneumonitis or interstitial lung disease; clinically significant uncontrolled heart disease, history of severe cutaneous reaction such as Steven-Johnson syndrome

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