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

Stopped early · Phase 2

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT01207102

Run by

Duke University

People needed

10

Starts

2011-08-01

Expected to finish

2014-06-01

Last updated by the study team

2014-12-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States
• Peking University School of Oncology/Beijing Cancer Hospital — Beijing, China

Full record on ClinicalTrials.gov

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