Study Of Abraxane® And Carboplatin As First-Line Treatment For Triple Negative Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Abraxane; Carboplatin
Intervention description: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days; area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days
Intervention MeSH terms: Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; Triple negative

Summary:

      Taxanes (such as paclitaxel) are highly active to treat breast cancer. Abraxane®
      (nanoparticle albumin-bound paclitaxel) compared to standard paclitaxel improves efficacy and
      tolerability. When combined with a taxane, platinum agents improve response in metastatic
      breast cancer, with carboplatin conferring less toxicity than cisplatin. The investigators
      hypothesize that the combination of weekly Abraxane® and carboplatin will lengthen time to
      progression without producing intolerable toxicity.
    

Eligibility criteria:

        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.