Novartis
V.C.G. Tjan-Heijnen (MUMC)
G. Frans (Novartis) A.E. van Leeuwen-Stok (BOOG Study Center)
Novartis
Novartis
E. van Druten (Research Nurse – coordination, RdGG)
This study will evaluate whether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with HR+,HER2-,AI treated locally advanced or metastatic breast cancer who progressed on or after mTor inhibitor based treatment.
Primary Outcome Measures: Progression Free Survival (PFS).
Secondary Outcome Measures: Overall survival (OS); Overall response rate (ORR); Clinical benefit rate (CBR); Type, frequency and severity of adverse events; Plasma concentration-time profiles of BKM120 – pharmacokinetics (PK); Patient reported outcome for global health status/QoL
Inclusion criteria: Postmenopausal women Breast cancer that is locally advanced or metastatic HER2 negative disease, and a known positive hormone receptor status (common breast cancer classification tests) A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization Prior treatment with AIs 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 Exclusion criteria: More than 1 prior chemotherapy given for locally advanced or metastatic disease Previous treatment with PI3K inhibitors, AKT inhibitors or fulvestrant Symptomatic CNS metastases Concurrent malignancy or malignancy within 3 years prior to start of study treatment Certain drugs or radiation within 2-4 weeks of enrollment Increasing or chronic treatment (>5 days) with corticosteroids or another immunosuppressive agent Active heart (cardiac) disease or a history of cardiac dysfunction as defined in the protocol Hypersensitivity to fulvestrant treatment excipients Certain scores on an anxiety and depression mood questionnaire given at screening Other protocol defined criteria may apply
