Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer

An Open-Label Randomized, Parallel, Two-Arm Phase II Study Comparing BMS-690514 + Letrozole With Lapatinib + Letrozole in Recurrent and Metastatic Breast Cancer Patients Who Are Hormone Receptor Positive Despite HER2 Status And Who Relapsed While Receiving or After Completing Adjuvant Antiendocrine Therapy

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 therapy

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