This is a study to determine the safety and effectiveness of BKM120 plus capecitabine in breast cancer patients with brain metastases. Both capecitabine and BMK120 have previously shown activity in patients with breast cancer. Like capecitabine, BMK120 is also effective in crossing the blood brain barrier making it a preferred candidate for its evaluation in patients with metastatic breast cancer (MBC).
Name: BKM120
Name: capecitabine
Name: Trastuzumab
Description: To determine the clinical benefit rate (CBR) based on local investigator assessment associated with BKM120 once daily plus capecitabine (1000 mg/m2 PO BID 14 days on/7 days off) in patients with metastatic breast cancer with a brain metastasis at least 5mm in size following whole brain radiation therapy (WBRT) and that has not progressed following WBRT. An exploratory analysis will be conducted of patients enrolled on study who have evidence of disease progression following WBRT. Clinical benefit rate is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) or stable disease (SD) in the CNS lasting at least 24 weeks based on local investigator assessment.
Measure: clinical benefit rate (CBR) Time: until end of study (4 years)Description: To assess ORR associated with BKM120 plus capecitabine in the central nervous system based on local investigator assessment
Measure: Objective Response Rate (ORR) Time: until end of study (4 years)Description: To assess median time to progression (TTP) associated with BKM120 plus capecitabine.
Measure: Median time to progression Time: until end of study (4 years)Description: To determine median overall survival (OS) associated with BKM120 plus capecitabine.
Measure: Median Overall Survival Time: until end of study (4 years)Description: To characterize the safety and tolerability of BKM120 plus capecitabine, with or without trastuzumab
Measure: Number of Adverse Events Time: until end of study (4 years)Description: To assess median time to deterioration of neurologic function based on answers to questionnaires.
Measure: Median time to deterioration of neurologic function Time: until end of study (4 years)Allocation: N/A
Single Group Assignment
There is one SNP
Patient is able to swallow and retain oral medication 22. Signed most recent patient informed consent form 23. Signed Patient Authorization Form Exclusion Criteria: 1. Patient received prior treatment with a P13K inhibitor. --- P13K ---