Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer
NCT00031278
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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%.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Farmington, Connecticut
- Plantation, Florida
- Baltimore, Maryland
- Boston, Massachusetts
- Ann Arbor, Michigan
- Livingston, New Jersey
- Pittsburgh, Pennsylvania
- Burlington, Vermont
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer | |||
Official Title ICMJE | 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 | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Carcinoma, Metastatic Breast | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 12 | |||
Original Enrollment ICMJE | 58 | |||
Actual Study Completion Date ICMJE | June 2003 | |||
Actual Primary Completion Date | June 2003 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | INCLUSION CRITERIA Inclusion Criteria
Exclusion Criteria
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00031278 | |||
Other Study ID Numbers ICMJE | C005 C005 A8501020 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | May 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |