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Phase II, Single Arm, Non-randomized Study of Alpelisib (BYL719) in Combination with Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer Big Ten Cancer Research Consortium BTCRC-BRE19-409

A Phase II, Single Arm, Non-randomized Study of Alpelisib (BYL719) in Combination with Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04762979
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Inclusion Criteria:
Men and postmenopausal female patients. Premenopausal patients (age 18 or older) who have been rendered postmenopausal will also be included.
Confirmed metastatic or unresectable breast cancer.
Has confirmed HER2 negative breast cancer.
Exclusion Criteria:
Patients with prior chemotherapy for metastatic or advanced disease
Treatment with any investigational drug within 14 days prior to registration.
Currently documented clinically active pneumonitis.
History of acute pancreatitis within 1 year of screening
Cancer
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Study Locations

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Location
Hershey, PA