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

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

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.

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