Phase II Study With Abraxane, Bevacizumab and Carboplatin in Triple Negative Metastatic Breast Cancer

Inclusion Criteria:

* Tissue block containing tumor to confirm metastatic breast cancer is required;
* Measurable disease according to RECIST criteria
* "Triple negative" disease defined as tumor demonstrating no expression for estrogen, progesterone or human epidermal growth factor receptor 2(HER2)receptors. "No expression" is categorized as ≤ 10% of cells staining or Allred ≤ 2;
* Aged 18 years or older;
* Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0 or 1; life expectancy ≥ 3 months;
* Patients may have received 0 - 1 prior therapies (except taxanes in the metastatic setting). An interval of at least 1 week must have elapsed since prior chemotherapy or hormonal therapy for metastatic disease; at least 6 months must have elapsed since prior adjuvant therapy;
* ≥ 2 weeks between surgery and study enrollment (≥ 4 weeks between major surgery (defined as open abdominal/thoracic/cardiac) and study enrollment;
* Laboratory tests performed within 14 days of study entry:

  * Granulocytes ≥ 1,500/µL;
  * Platelets ≥ 100,000/µL;
  * Hemoglobin ≥ 9 gm/dL;
  * Total bilirubin ≤ institutional upper limit of normal (ULN);
  * Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 5 times ULN;

    * Alkaline phosphatase ≤ 2.5 times ULN;
  * Estimated creatinine clearance ≥ 60 mL/min.
* left ventricular ejection fraction (LVEF)≥ 50% by multigated acquisition (MUGA)/Echocardiogram;
* Informed consent to receive protocol treatment, to provide biologic specimens, and to complete neurotoxicity questionnaires;
* Cognitive and communication skills to comply with study and/or follow-up procedures;
* No reproductive potential:

  * If pre-menopausal: Negative serum pregnancy test and patient agreement to use adequate contraceptive method (abstinence, intrauterine device, barrier device with spermicide or surgical sterilization) during and for 3 months after completion of treatment.
  * If post-menopausal: Amenorrhea for ≥ 12 months.

Exclusion Criteria:

* Pregnant or breast feeding;
* Prior treatment with Abraxane®, carboplatin or bevacizumab, or any taxane for metastatic breast cancer;
* Known hypersensitivity to any component of any study drug;
* Active infection;
* Current neuropathy ≥ grade 2;
* central nervous system (CNS) metastases as determined by head CT with contrast;
* History of bleeding within the past 6 months or active bleeding disorder;
* Serious non-healing wound, ulcer or bone fracture;
* Uncontrolled congestive heart failure (CHF), or history of myocardial infarction(MI), unstable angina, stroke, or transient ischemia within previous 6 months;
* Inadequately controlled hypertension (defined as systolic blood pressure \< 150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications; prior history of hypertensive crisis or hypertensive encephalopathy;
* Proteinuria (defined as urine protein: creatinine (UPC) ratio ≥ 1.0 or urine dipstick ≥ 2+.
* Significant vascular disease (aortic aneurysm, aortic dissection) or symptomatic peripheral vascular disease;
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within previous 6 months;
* Uncontrolled serious contraindicated medical condition or psychiatric illness.