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Protocol Summary


Protocol No.
PSCI-21-006
Prinicipal Investigator
Truica, Cristina
Phase
Phase II
Age Group
Adult
Scope
National
Secondary Protocol No.
BTCRC BRE19-409
Title
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 Big Ten Cancer Research Consortium BTCRC-BRE19-409
Objective
Primary Objective:
To estimate the progression-free survival (PFS) of alpelisib with continued
endocrine therapy (aromatase inhibitor or fulvestrant) following progression
in patients with hormone receptor positive, HER2 negative, PIK3CA mutant
metastatic breast cancer.

Secondary Objectives:
To estimate the objective response rate (ORR) of alpelisib with
continued endocrine therapy (aromatase inhibitor or fulvestrant)
following progression in patients with hormone receptor positive, HER2
negative, PIK3CA mutant metastatic breast cancer.
To estimate the clinical benefit rate (CBR) of alpelisib with continued
endocrine therapy (aromatase inhibitor or fulvestrant) following
progression in patients with hormone receptor positive, HER2 negative,
PIK3CA mutant metastatic breast cancer.
To estimate duration of response (DoR) of alpelisib with continued
endocrine therapy (aromatase inhibitor or fulvestrant) following
progression in patients with hormone receptor positive, HER2 negative,
PIK3CA mutant metastatic breast cancer.
To estimate the overall survival (OS) of alpelisib with continued
endocrine therapy (aromatase inhibitor or fulvestrant) following
progression in patients with hormone receptor positive, HER2 negative,
PIK3CA mutant metastatic breast cancer.
To estimate grade 3-4 adverse events or events of any grade leading to
dose adjustments of alpelisib with continued endocrine therapy
(aromatase inhibitor or fulvestrant) following progression in patients
with hormone receptor positive, HER2 negative, PIK3CA mutant
metastatic breast cancer.
Applicable Disease Sites
Breast
Status
Open
Participating Institutions
Hershey Medical Center