Spots Global Cancer Trial Database for Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer
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Trial Identification
Brief Title: Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer
Official Title: A Phase I/II Open Label, Multi-Center Study For The Evaluation Of The Combination Of CpG 7909 And Herceptin® In Patients With Metastatic Breast Cancer
Study ID: NCT00031278
Conditions
Study Description
Brief 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.
Detailed Description: Phase II part of study not initiated because the development plan modified the route of administration to subcutaneous injection.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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
Contact Details
Name: Harold Burstein, M.D., Ph.D.
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
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