Back to results

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

Primary Purpose

Metastatic Breast Cancer

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Abraxane

Carboplatin

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Breast cancer, Triple negative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Duke University Medical Center
Peking University School of Oncology/Beijing Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abraxane, Carboplatin

Arm Description

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

Outcomes

Primary Outcome Measures

PFS

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

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

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.

Full Information

NCT ID

NCT01207102

First Posted

September 10, 2010

Last Updated

December 8, 2014

Sponsor

Duke University

Collaborators

Celgene Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01207102

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Terminated

Why Stopped

Low enrollment and there is insufficient data to publish.

Study Start Date

August 2011 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Celgene Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Breast Cancer

Keywords

Breast cancer, Triple negative

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Abraxane, Carboplatin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Abraxane

Other Intervention Name(s)

paclitaxel protein-bound particles for injectable suspension

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

Paraplatin

Intervention Description

area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days

Primary Outcome Measure Information:

Title

PFS

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kimberly L Blackwell, MD

Organizational Affiliation

Duke University

Official's Role

Study Chair

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Peking University School of Oncology/Beijing Cancer Hospital

City

Beijing

ZIP/Postal Code

100142

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs