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
- Subject has histologically-confirmed HER2-positive breast cancer that is advanced (loco-regionally not amenable to surgery or is metastatic).
- Subject has received pre-study induction therapy with up to and including 6 cycles of a taxane (docetaxel, paclitaxel, or nab-paclitaxel), plus trastuzumab and pertuzumab. A minimum of 4 cycles of taxane is permitted if discontinuation was due to toxicity
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Subject has adequate bone marrow and organ function
- Applies only to Part 2: Subject has a PIK3CA mutation(s) present in tumor tissue prior to enrollment, as determined by a Novartis designated central laboratory.
- Subject with inflammatory breast cancer at screening.
- Subject 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)
- Subject with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on fasting plasma glucose (FPG) and HbA1c.
- Subject has a known history of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis
- Subject has clinically significant, uncontrolled heart disease and/or recent cardiac events
- Subject has a history of Steven-Johnson Syndrome (SJS), erythema multiforme (EM) or Toxic Epidermal Necrolysis (TEN).
- Subject has currently documented pneumonitis/interstitial lung disease
Trial Phase Phase III
Trial Type Treatment
Novartis Pharmaceuticals Corporation
- Primary ID CBYL719G12301
- Secondary IDs NCI-2020-02351, 2019-002741-37
- Clinicaltrials.gov ID NCT04208178