Taxane Therapy With or Without Bavituximab for the Treatment of HER2-Negative Metastatic Breast Cancer

Inclusion Criteria

• •1. Written informed consent obtained prior to screening.
• •2. Females or males at least 18 years of age.
• •3. Histologically or cytologically documented metastatic HER2-negative breast cancer.
• •4. Measurable disease per RECIST 1.1 (Phase II); evaluable disease (Phase III)
• •5. ECOG performance status of 0 or 1.
• •6. Adequate hematologic function: absolute neutrophil count ≥1500 cells/µL; hemoglobin ≥9 g/dL; platelets ≥100,000/µL.
• •7. Adequate renal function: serum creatinine ≤1.8 mg/dL or calculated creatinine clearance \>50 mL/min using the Cockcroft-Gault equation.
• •8. Adequate hepatic function: total bilirubin ≤ upper limit of normal (ULN), serum albumin ≥3.0 g/dL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN. ALT and/or AST may be ≤5 × ULN if due to liver metastases. If ALT or AST is \>1.5 and ≤5 × ULN in patients with liver metastases, alkaline phosphatase must be ≤2.5 × ULN. Patients with Gilbert's syndrome are allowed if total bilirubin is ≤2 × ULN and direct bilirubin is ≤ULN.
• •9. Prothrombin time (PT) and/or international normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) ≤1.5 × ULN if patient is not on anticoagulant therapy (a therapeutic PT and/or INR and aPTT is acceptable if the patient is on anticoagulants).
• •10. Patients must have a negative serum human chorionic gonadotropin test within 1 week of Day 1 (pregnancy test not required for patients with bilateral oophorectomy and/or hysterectomy or for those patients who are \>1 year postmenopausal).
• •11. All patients of reproductive potential (ie, not surgically sterile or postmenopausal) must agree to use a highly effective method of contraception (\<1% failure rate per year) during and 3 months after end of study treatment (female) or during and 6 months after the end of study treatment (male).
• •11. Major surgery within 4 weeks of Day 1.
• •12. Uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease, active infections).
• •13. Autoimmune disease, being treated with immunosuppressive drugs (eg, methotrexate or biological agents), or other conditions requiring immunosuppressive therapy (eg, prior allotransplantation).
• •14. History of hypersensitivity to bavituximab, docetaxel, paclitaxel, or to any of their excipients.
• •15. Symptomatic coronary artery disease, cerebrovascular accident or transient ischemic attack, myocardial infarction, arterial embolism, or unstable angina pectoris within 6 months of screening.
• •16. Currently pregnant, nursing, or planning a pregnancy during the study.
• •17. Investigational therapy within 28 days prior to Day 1.
• •18. Patient has a condition or is in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.