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

Sponsor:	Duke University
Collaborator:	Celgene Corporation
Information provided by (Responsible Party):	Duke University
ClinicalTrials.gov Identifier:	NCT01207102

Purpose

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.

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: Abraxane Drug: Carboplatin	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Abraxane® and Carboplatin as First-line Treatment for "Triple Negative" (Demonstrating no Expression for Estrogen, Progesterone, or HER2 Receptors) Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

PFS [ Time Frame: PFS is defined as the interval from study registration to disease progression or death due to any cause, whichever comes first ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Asses safety and tolerability of a combination regimen of Abraxane® and carboplatin [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	70
Study Start Date:	August 2011
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days

Other Name: paclitaxel protein-bound particles for injectable suspension

AUC=2 over 15 minutes days 1,8,15 every 28 days

Other Name: Paraplatin

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with histologically or cytologically confirmed diagnosis of metastatic (Stage IV) breast cancer;
Measurable disease according to 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;
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.
LVEF ≥ 50% by 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 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.
CNS metastases as determined by head CT with contrast or head MRI.
Uncontrolled CHF, or history of MI, unstable angina, stroke, or transient ischemia within previous 6 months.
Uncontrolled serious contraindicated medical condition or illness.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207102

Contacts

Contact: Renee Welch, BSN	919-660-1278	renee.welch@duke.edu
Contact: Kimberly Blackwell, MD	919-668-1748	kimberly.blackwell@duke.edu

Locations

United States, North Carolina
Duke University Medical Center	Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Renee Welch, RN 919-660-1278 welch023@mc.duke.edu
Contact: Gloria Rocha 919-684-3595 gloria.rocha@duke.edu
Principal Investigator: Kimberly Blackwell, MD
China
Peking University School of Oncology/Beijing Cancer Hospital	Recruiting
Beijing, China, 100142
Contact: Xinna Zhou 86-10-88196023 xinnazhou@bjcancer.org
Principal Investigator: Jun Ren, MD, PhD

Sponsors and Collaborators

Duke University

Celgene Corporation

Investigators

Study Chair:

Kimberly L Blackwell, MD

Duke University

More Information

No publications provided

Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT01207102 History of Changes
Other Study ID Numbers:	Pro00019321
Study First Received:	September 10, 2010
Last Updated:	September 29, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

Breast cancer
Triple negative

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 23, 2012