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Clinical Research & Trials

USO 19122

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Assess The Efficacy And Safety Of Alpelisib (BYL719) In Combination With Nab-Paclitaxel In Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-Kinase Catalytic Subunit Alpha (PIK3CA) Mutation Or Phosphatase And Tensin Homolog Protein (PTEN) Loss Without PIK3CA Mutation (CBYL719H12301)


Disease Types: Breast Cancer Research

Eligibility Requirements:

-Locally advanced or metastatic triple negative breast cancer with PIK3CA or PTEN mutation, tissue
available for confirmation or willing to undergo biopsy 
-No prior treatment with PI3K, MTOR, or AKT inhibitors or more than one line of therapy in metastatic setting
-No active CNS involvement or inflammatory breast cancer
-No GI condition that could effect oral absorption, type I or uncontrolled type II diabetes
-No history of chronic pancreatitis, acute pancreatitis, pneumonitis, insterstitial lung disease

Available at: