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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01207102
Recruitment Status : Terminated (Low enrollment and there is insufficient data to publish.)
First Posted : September 22, 2010
Results First Posted : December 15, 2014
Last Update Posted : December 15, 2014
Celgene Corporation
Information provided by (Responsible Party):
Duke University

September 10, 2010
September 22, 2010
December 8, 2014
December 15, 2014
December 15, 2014
August 2011
June 2014   (Final data collection date for primary outcome measure)
PFS [ Time Frame: PFS is defined as the interval from study registration to disease progression or death due to any cause, whichever comes first ]
The primary objective of the trial is to statistically test whether Abraxane® and carboplatin can improve progression-free survival (PFS) as compared to historical controls.
Same as current
Complete list of historical versions of study NCT01207102 on Archive Site
To Assess the Safety and Tolerability of a Combination Regimen of Weekly Abraxane® and Carboplatin to Treat Women With "Triple Negative" Stage IV Metastatic Breast Cancer [ Time Frame: 2 years ]
The proportion of patients experiencing any neurotoxicity will be tabulated by grade. The proportion of patients experiencing ≥ grade 3 non-hematologic toxicities (excluding neurotoxicity) and the proportion of patients experiencing ≥ grade 3 hematologic toxicities will be calculated with their exact 80% confidence intervals.
Safety [ Time Frame: 2 years ]
To assess the safety and tolerability of a combination regimen of weekly Abraxane® and carboplatin to treat women with "triple negative" Stage IV metastatic breast cancer
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Study Of Abraxane® And Carboplatin As First-Line Treatment For Triple Negative Metastatic Breast Cancer
A Phase II Study of Abraxane® and Carboplatin as First-line Treatment for "Triple Negative" (Demonstrating no Expression for Estrogen, Progesterone, or Human Epidermal Growth Factor Receptor 2 (HER2)Receptors) Metastatic Breast Cancer
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.

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 chemotherapeutic agents, and have been incorporated into treatment regimens for women who fail previous anthracycline-based therapies. Although both agents are notable for favorable response rates, they are also associated with a variety of adverse events, some of which may be dose-limiting and having a negative effect on quality of life: myelosuppression, nausea and vomiting, diarrhea, stomatitis/mucositis, short- and long-term neuropathy, nephrotoxicity, alopecia and hypersensitivity reactions.

As second-generation compounds, Abraxane® and carboplatin have been shown to improve response rates and may mediate some of the toxicities associated with paclitaxel and cisplatin, respectively. Of particular interest is Abraxane's potential to reduce allergic reactions associated with other taxanes.

This study combines these two agents: primarily, to evaluate progression-free survival; and secondarily, to assess the feasibility and tolerability of this regimen to treat poor prognosis metastatic breast cancer patients.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: Abraxane
    Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days
    Other Name: paclitaxel protein-bound particles for injectable suspension
  • Drug: Carboplatin
    area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days
    Other Name: Paraplatin
Experimental: Abraxane, Carboplatin
Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle
  • Drug: Abraxane
  • Drug: Carboplatin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2014
June 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
China,   United States
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Duke University
Duke University
Celgene Corporation
Study Chair: Kimberly L Blackwell, MD Duke University
Duke University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP