Trial Information
A Phase II Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall response rate (complete response + partial response) to a combination of bavituximab plus docetaxel in patients with metastatic breast cancer
Outcome Time Frame:
Up to six (6) 28-day cycles of docetaxel plus weekly bavituximab until disease progression. After chemotherapy, weekly bavituximab is continued until disease progression. Approximate duration 1 year.
Safety Issue:
No
Authority:
Georgia: Ministry of Health
Study ID:
PPHM 0704
NCT ID:
NCT00669591
Start Date:
January 2008
Completion Date:
August 2010
Related Keywords:
- Breast Cancer
- breast cancer
- docetaxel chemotherapy
- bavituximab
- monoclonal antibody
- Breast Neoplasms