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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
We are asking you to take part in this voluntary research study because you have breast cancer that is estrogen and progesterone receptor positive and is HER2 receptor negative. Your breast cancer also spread outside your breast (metastatic) to other areas of your body. We are asking you to take part in this research study because your cancer has a genetic mutation in a pathway called PI3K and your tumor progressed while you were receiving hormone therapy.
All
18 year(s) or older
NCT04762979
STUDY00017417
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 diseaseTreatment 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