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Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation
Trial Status: closed to accrual
The purpose of this two part multicenter, randomized, double-blind, placebo-controlled,
Phase III study is to evaluate the efficacy and safety of alpelisib compared to alpelisib
matching-placebo in combination with trastuzumab and pertuzumab as maintenance treatment
of patients with HER2-positive advanced breast cancer whose tumor harbors a PIK3CA
mutation following induction therapy with a taxane in combination with trastuzumab and
pertuzumab. Part 1 is the open-label, safety run-in part of the study, designed to
confirm the recommended phase 3 dose (RP3D) dose of alpelisib in combination with
trastuzumab and pertuzumab. Following Part 1, Part 2 will be initiated, which is the
randomized, Phase III part of the study.
Inclusion Criteria
Participant has histologically-confirmed HER2-positive breast cancer that is advanced (loco-regionally not amenable to surgery or is metastatic).
Participant has received pre-study induction therapy with up to and including a maximum of 8 cycles of a taxane (docetaxel, paclitaxel, or nab-paclitaxel), plus trastuzumab and pertuzumab. 4 or 5 cycles of induction therapy are permitted if discontinuation of taxane was due to taxane toxicity. Of note, participants enrolled in Part 1 of this study received 4-6 cycles of pre-study induction therapy.
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Participant has adequate bone marrow and organ function
Applies only to Part 2: Participant has a PIK3CA mutation(s) present in tumor prior to enrollment, locally confirmed per test listed in protocol or as determined by a Novartis designated central laboratory.
Exclusion Criteria
Participant with inflammatory breast cancer at screening.
Participant with evidence of disease progression during the pre-study induction therapy and prior to first dose of alpelisib (or alpelisib/alpelisib matching-placebo for Part 2)
Participant with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on fasting plasma glucose (FPG) and HbA1c.
Participant has a known history of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis
