Overview
Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer
Status:
Completed
Completed
Trial end date:
2010-12-01
2010-12-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
The purpose of this study is to determine if BMS-690514 + letrozole will be more effective than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast cancer after developing progressive disease immediately following adjuvant antiendocrine therapyPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Bristol-Myers SquibbTreatments:
Lapatinib
Letrozole
Criteria
Inclusion Criteria:- Documented invasive breast cancer
- Greater than 10% tumor cells positive for estrogen receptor and/or progesterone
receptor
- HER2+ and HER2- (Human Epidermal growth factor Receptor) disease
- Rapid disease progression despite treatment with tamoxifen, anastrozole or exemestane
- ECOG Performance status = 0 or 1
Exclusion Criteria:
- Prior hormonal therapy for metastatic disease
- Prior hormonal therapy with letrozole for adjuvant disease
- Symptomatic brain metastases
- Prior treatment with any tyrosine kinase inhibitor