Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

February 7, 2017

Study Completion Date

December 31, 2018

Conditions
Metastatic Breast Cancer
Interventions
DRUG

BMK120

BKM120 PO 50, 80 or 100mg every day for each day of each 21 day cycle. Number of cycles: until progression of disease; unacceptable toxicity, withdrawal or death.

DRUG

Capecitabine

875-1250mg/m2 PO BID for two weeks followed by one week rest every three week cycle. Number of cycles: until progression of disease, unacceptable toxicity, withdrawal or death.

DRUG

BYL719

BYL719 200mg PO BID for 21 days (3 weeks) in combination with capecitabine 1000 mg/m2 PO BID for 2 weeks

DRUG

Trastuzumab

trastuzumab infusion on day 1 of each cycle.

DRUG

Lapatinib

lapatinib daily for 21 days in each cycle.

Trial Locations (2)

27599

Lineberger Comprehensive Cancer Center, Chapel Hill

27710

Duke Comprehensive Cancer Center, Durham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

UNC Lineberger Comprehensive Cancer Center

OTHER