Study Of Abraxane® And Carboplatin As First-Line Treatment For Triple Negative 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;
* Eastern Cooperative Oncology Group (ECOG)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.