Study Of Abraxane® And Carboplatin As First-Line Treatment For Triple Negative Metastatic Breast Cancer

• Status: Terminated
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Celgene Corporation
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

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.