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

Completed · Phase 1/Phase 2

Conditions studied: Carcinoma, Metastatic Breast

In brief

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.

Key facts

Study ID

NCT00031278

Run by

Pfizer

People needed

12

Starts

2001-10-01

Expected to finish

2003-06-01

Last updated by the study team

2011-05-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• 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%.

Where it is running

• Univ. of Connecticut Health Center — Farmington, Connecticut, United States
• Cancer Research Network, Inc. — Plantation, Florida, United States
• Greenebaum Cancer Center at Univ. of Maryland — Baltimore, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Comprehensive Cancer Center, University of Michigan — Ann Arbor, Michigan, United States
• Cancer Center at Saint Barnabas Medical Center — Livingston, New Jersey, United States
• Univ. of Pittsburgh Cancer Institute, Magee Women's Hosp. — Pittsburgh, Pennsylvania, United States
• Fletcher Allen Health Care — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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