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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

Phase 2
18 Years
Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

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

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.

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

- "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;

- 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

- Informed consent to receive protocol treatment:

- Cognitive and communication skills adequate to comply with study and/or follow-up

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

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.

Outcome Time Frame:

PFS is defined as the interval from study registration to disease progression or death due to any cause, whichever comes first

Safety Issue:


Principal Investigator

Kimberly L Blackwell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke University


United States: Institutional Review Board

Study ID:




Start Date:

August 2011

Completion Date:

December 2014

Related Keywords:

  • Metastatic Breast Cancer
  • Breast cancer
  • Triple negative
  • Breast Neoplasms



Duke University Medical Center Durham, North Carolina  27710