Study of Dasatinib (BMS-354825) in Patients With Advanced Estrogen/Progesterone Receptor-positive (ER+/PR+) or Her2/Neu-positive (Her2/Neu+)Breast Cancer

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Dasatinib; Estrogens; Progesterone

Criteria

Inclusion Criteria:

• females, 18 or older

• recurrent, locally advanced, or metastatic breast cancer with expression of ER/PR receptor and/or overexpression of Her2/neu

• paraffin-embedded tissue block must be available

• measurable disease

• prior chemotherapy with an anthracycline and/or a taxane (neoadjuvant, adjuvant, or metastatic setting)

• 0, 1 or 2 chemotherapies in the metastatic setting

• adequate organ function

Exclusion Criteria:

• Metastatic disease confined to bone only

• Symptomatic central nervous system (CNS) metastasis

• Concurrent medical condition which may increase the risk of toxicity

• Unable to take oral medication