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

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