A Phase II Study of Abraxane®, Carboplatin and Bevacizumab in "Triple Negative" (Demonstrating No Expression for Estrogen, Progesterone, or Her2 Receptors) 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.