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