A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi

Key inclusion criteria

Female patients age 18 years or older
Histologically and/or cytologically confirmed diagnosis of breast cancer
Radiologic evidence of inoperable locally advanced or metastatic breast cancer
Adequate tumor tissue for the analysis of PI3K-related biomarkers
Human epidermal growth factor receptor-2 (HER2) negative disease, and a known positive hormone receptor status
Postmenopausal women
Prior treatment with aromatase inhibitors
Evidence of progression to the combination of mTORi and endocrine therapy given as the last therapy prior to study entry
Adequate bone marrow and organ function
ECOG performance status ≤ 2

Key exclusion criteria

Previous treatment with PI3K inhibitors, protein kinase B inhibitors or fulvestrant
More than one chemotherapy line for metastatic disease
Hypersensitivity to any of the excipients of buparlisib or fulvestrant
Symptomatic central nervous system metastases
Concurrent malignancy or malignancy within 3 years of study enrollment
Certain drugs or radiation within 2-4 weeks of enrollment
Increasing or chronic treatment (>5 days) with corticosteroids or another immunosuppressive agent
Certain scores on an anxiety and depression mood questionnaire given at screening
Acute viral hepatitis or a history of chronic or active hepatitis B virus or hepatitis C virus
Active cardiac disease or a history of cardiac dysfunction