Status:
TERMINATED
Study Of Abraxane® And Carboplatin As First-Line Treatment For Triple Negative Metastatic Breast Cancer
Lead Sponsor:
Duke University
Collaborating Sponsors:
Celgene Corporation
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 combin...
Detailed Description
Paclitaxel and cisplatin are well-recognized for their activity in treating a variety of tumors including breast cancer. As cytotoxins, they have been studied alone and in combination with other chemo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01207102
Start Date
August 1 2011
End Date
June 1 2014
Last Update
December 15 2014
Active Locations (2)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710
2
Peking University School of Oncology/Beijing Cancer Hospital
Beijing, China, 100142