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

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