A Phase II Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- Bavituximab
- Conditions
- Breast Cancer
- Sponsor
- Peregrine Pharmaceuticals
- Enrollment
- 46
- Locations
- 4
- Primary Endpoint
- Overall response rate (complete response + partial response) to a combination of bavituximab plus docetaxel in patients with metastatic breast cancer
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of the study is to determine the overall response to a combination of bavituximab and docetaxel in patients with advanced breast cancer
Investigators
Eligibility Criteria
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
Arms & Interventions
1
Patients will receive up to six (6) 28-day cycles of docetaxel plus weekly bavituximab during the treatment phase. During the follow-up phase, patients will continue to receive weekly bavituximab until disease progression
Intervention: Bavituximab
Outcomes
Primary Outcomes
Overall response rate (complete response + partial response) to a combination of bavituximab plus docetaxel in patients with metastatic breast cancer
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.
Secondary Outcomes
- Secondary objectives include time to tumor progression, duration of response, overall survival, and safety.(Approximately 1 year)