Breast Cancer Clinical Trial

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Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer

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Summary

The purpose of this study is to determine if the combination of CPG 7909 and Herceptin is safe and effective in the treatment of metastatic breast cancer.

RATIONALE: There is preclinical data that supports the hypothesis that CPG 7909 may potentiate the action of Herceptin. This Phase I/II study is designed to evaluate the safety and efficacy of the combination treatment of CPG 7909 and Herceptin in patients with metastatic breast cancer who have previously been treated with Herceptin and chemotherapy.

SCHEDULE: Patients will receive CPG 7909 weekly for up to six months.

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Full Description

Phase II part of study not initiated because the development plan modified the route of administration to subcutaneous injection.

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Eligibility Criteria

INCLUSION CRITERIA Inclusion Criteria

Histologically confirmed breast cancer with metastases.
Tumor that has overexpression of HER2 as documented by being either FISH-positive or HER2/neu 3+ confirmed by immunohistochemistry.
Patients must be candidates for single agent Herceptin treatment according to the Herceptin® label.

Exclusion Criteria

Any prior therapy with anthracycline + Herceptin®.
Significant cardiovascular disease (e.g., NYHA class 3 congestive heart failure, myocardial infarction within the past 6 months, unstable angina; coronary angioplasty within the past 6 months, uncontrolled atrial or ventricular cardiac arrhythmias) or left ventricular ejection fraction < 50%.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

12

Study ID:

NCT00031278

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 8 Locations for this study

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Univ. of Connecticut Health Center
Farmington Connecticut, 06030, United States
Cancer Research Network, Inc.
Plantation Florida, 33324, United States
Greenebaum Cancer Center at Univ. of Maryland
Baltimore Maryland, 21201, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
Comprehensive Cancer Center, University of Michigan
Ann Arbor Michigan, 48109, United States
Cancer Center at Saint Barnabas Medical Center
Livingston New Jersey, 07039, United States
Univ. of Pittsburgh Cancer Institute, Magee Women's Hosp.
Pittsburgh Pennsylvania, 15213, United States
Fletcher Allen Health Care
Burlington Vermont, 05401, United States
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How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

12

Study ID:

NCT00031278

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

Clinical Trial Resources

SurvivorNet’s Guide To Clinical Trials: What Are They And Are They Right for You?
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