A Phase II Study of Abraxane® and Carboplatin as First-line Treatment for "Triple Negative" (Demonstrating no Expression for Estrogen, Progesterone, or Human Epidermal Growth Factor Receptor 2 (HER2)Receptors) Metastatic Breast Cancer

Inclusion Criteria:

- Patients with histologically or cytologically confirmed diagnosis of metastatic
(Stage IV) breast cancer;

- Measurable disease according to Response Evaluation Criteria in Solid Tumors
(RECIST);

- "Triple negative" disease defined as "tumor demonstrating no expression for estrogen,
progesterone or HER2 receptors." (No expression is categorized as ≤ 10% of cells
staining or Allred ≤ 2);

- Aged 18 years or older;

- ECOG/Zubrod performance status of 0 or 1; life expectancy ≥ 3 months;

- No prior chemotherapy for metastatic disease.

- At least 6 months must have elapsed since prior adjuvant chemotherapy.

- Laboratory tests performed within 14 days of study entry showing:

- Granulocytes ≥ 1,500/µL;

- Platelets ≥ 100,000/µL;

- Hemoglobin ≥ 9.0 gm/dL;

- Total bilirubin ≤ institutional upper limit of normal (ULN);

- Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN;

- Alkaline phosphatase ≤ 5 times ULN;

- Estimated creatinine clearance ≥ 60 mL/min.

- Urine protein:creatinine ratio ≤ 1.0. or 24 hour urine protein collection
demonstrating ≤ 1 gram of protein per 24 hours to be eligible.

- left ventricular ejection fraction (LVEF) ≥ 50% by multiple gated acquisition scan
(MUGA)/Echocardiogram;

- Informed consent to receive protocol treatment:

- Cognitive and communication skills adequate to comply with study and/or follow-up
procedures;

- Geographic proximity and ability to comply with weekly study visits for the duration
of the treatment;

- No reproductive potential:

- If pre-menopausal - Negative serum pregnancy test within 3 days prior to
initiation of protocol-based treatment and patient agrees to use contraceptive
method (abstinence, intrauterine device, barrier device with spermicide or
surgical sterilization) during and for 3 months after completion of protocol
treatment;

- If post-menopausal - Amenorrhea for ≥ 12 months or follicle stimulating hormone
(FSH) within post menopausal range.

Exclusion Criteria:

- Pregnant or breast feeding.

- Prior treatment with Abraxane® or carboplatin.

- Prior chemotherapy 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 or
head MRI.

- Uncontrolled congestive heart failure (CHF), or history of myocardial ischemia (MI),
unstable angina, stroke, or transient ischemia within previous 6 months.

- Uncontrolled serious contraindicated medical condition or illness.