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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: 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 therapy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: 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