Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin to Treat Breast Cancer

Study Overview
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Brief Summary
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This is a phase II, multicenter, single-arm, open-label safety and efficacy study of bavituximab in combination with carboplatin plus paclitaxel in patients with locally advanced or metastatic breast cancer.

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

Conditions
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Carcinoma Breast Stage IV

Intervention / Treatment
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* Drug: Bavituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Living in India for the duration of the study Adult females over age 18 years of age with a life expectancy of at least 3 months Confirmed breast cancer with evidence of locally advanced or metastatic disease Disease that is measurable by radiology imaging Ambulatory and capable of all selfcare but unable to carry out any work activities. Adequate laboratory results (hematologic, renal, hepatic) Negative pregnancy test Exclusion Criteria: History of or susceptibility to bleeding or coagulopathy (e.g., von Willebrand Disease or Hemophilia) Any history of thromboembolic events (clots within blood vessels) Ongoing treatment with high doses of anticoagulants Use of hormone therapy Advanced peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities) Prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy Radiotherapy within 2 weeks entering the study Chemotherapy, immunotherapy or radiotherapy within 4 weeks of starting the study Allergies to Polysorbate 80 or drugs containing polyoxyethylated castor oil (e.g. cyclosporine) Diagnosed and active CNS disease or metastatic lesions Major surgery within 4 weeks of starting the study Pregnant or nursing Uncontrolled disease (e.g., diabetes, hypertension, thyroid disease) History of heart disease History of any condition requiring treatment with anti-inflammatory, anti-platelet drugs or steroids Diagnosed with HIV or hepatitis

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bavituximab|Receive weekly bavituximab at a dose of 3 mg/kg until disease progression, and carboplatin at a dose of AUC = 2 and paclitaxel 100 mg/m2 on days 1, 8, and 15 of a 28-day cycle for up to 6 cycles.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to determine the overall response rate (CR+PR) |  | Until disease progression | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally Advanced or Metastatic Breast Cancer