A Phase II Study Of Abraxane and Nexavar in the First-Line Treatment of Locally Advanced or Metastatic Breast Cancer

Exclusion Criteria

• •1. Patients who have received prior chemotherapy for the treatment of locally advanced or metastatic breast cancer.
• •2. Patients who have received prior Abraxane or Nexavar.
• •3. Patients who have a history of hypersensitivity or a suspected allergy to taxanes, any of the components in taxanes, Abraxane, or Nexavar.
• •4. Patients with serious intercurrent medical or psychiatric illness, including serious active infection.
• •5. Patients with untreated or active brain metastases. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
• •6. Patients with a history of thrombosis.
• •7. Patients with thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
• •8. Patients with symptomatic congestive heart failure or a baseline echocardiogram with LVEF \< ULN.
• •9. Patients with congestive heart failure \> class II New York Heart Association (NYHA). Patients must not have unstable angina (anginal symptoms at rest), or new onset angina (began within the last 3 months), or myocardial infarction within the past 6 months.
• •10. Patients with cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• •11. Patients with a history of, or active, bowel perforation or inflammatory bowel disease.
• •12. Patients with active peptic ulcer disease or symptoms to suggest possible ulcer (discontinuation of chronic NSAID therapy advised, or if not possible, use of proton-pump inhibitors recommended.)
• •13. Patients planning to receive any concurrent therapy to treat locally advanced or metastatic breast cancer during the study treatment period.
• •14. Any patient who is pregnant or lactating.
• •15. Patients with proteinuria \> +1 by baseline dipstick, or if +2, 24-hour urine total protein \> 250 mg.
• •16. Patients who have undergone major surgery, open biopsy, or significant traumatic injury within 28 days, or minor surgery within 14 days. (The placement of a Mediport or other vascular access device is permitted if performed at least 7 days prior to registration).
• •17. Patients with \> Grade 2 peripheral neuropathy (NCI-CTC v3.0) or any painful neuropathy.
• •18. Patients who have experienced any type of bone fracture within 12 months or who have undergone joint replacement surgery within 6 months.
• •19. Patients with a serious non-healing wound.
• •20. Patients with known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
• •21. Patients requiring anticoagulants (with the exception of low-dose Coumadin, ASA, Plavix or Heparin for maintenance of vascular access patency).
• •22. Patients with evidence or history of bleeding diathesis or coagulopathy.
• •23. Patients experiencing any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug.
• •24. Patients with pulmonary hemorrhage/bleeding event \> CTCAE Grade 2 within 4 weeks of first dose of study drug.
• •25. Patients with any condition that impairs a patient's ability to swallow whole pills or patients with any malabsorption problems.
• •26. Patients who use St. John's Wort or rifampin (rifampicin).