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

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

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Bavituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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 | Drug: Bavituximab<br>* Weekly bavituximab infusion of 3 mg/kg combined with up to six 28-day cycles of docetaxel chemotherapy. After treatment phase, weekly bavituximab maintenance is continued until disease progression.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (complete response + partial response) to a combination of bavituximab plus docetaxel in patients with metastatic breast cancer |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary objectives include time to tumor progression, duration of response, overall survival, and safety. |  | Approximately 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, docetaxel chemotherapy, bavituximab, monoclonal antibody