A Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Advanced Breast Cancer

A Phase II Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Breast Cancer

The purpose of the study is to determine the overall response to a combination of bavituximab and docetaxel in patients with advanced breast cancer

Inclusion Criteria:

• Adult females over age 18 with life expectancy of at least 3 months
• Histologically or cytologically confirmed locally advanced or metastatic breast cancer
• One and only one prior chemotherapy regimen (no prior docetaxel)
• Measurable disease (at least one target lesion)at least 2 cm in longest diameter (1 cm by spiral CT)
• Adequate hematologic, renal, and hepatic function;

Exclusion Criteria:

• Known history of bleeding diathesis or coagulopathy
• Any current evidence of clinically significant bleeding
• Any history of thromboembolic events
• Concurrent hormone therapy
• Prior immunotherapy or radiotherapy to an area of measurable disease unless disease has recurred after radiotherapy