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Breast Cancer Trial of an Investigational Drug versus Capecitabine in Male or Female Patients with Advanced Breast Cancer
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Phase
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Protocol IDs
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Phase III
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Treatment
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Active
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18 and over
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Pharmaceutical / Industry
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XRP9881B/3001
NCT00081796
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Trial Description
Summary The purpose of this clinical trial is to determine if the investigational drug is a better treatment than capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from docetaxel and/or paclitaxel. Further Study Information All patients in this trial will receive either the investigational drug or capecitabine, a chemotherapy drug that is already approved to treat your disease. These drugs prevent tumor cells from dividing, so they may stop growing or die. The investigational drug in this clinical trial is a chemotherapy drug given through the vein once every three weeks. Patients who receive capecitabine will receive this drug by mouth for 14 days, every 21 days. Eligibility Criteria Eligibility Criteria In order to be eligible for this trial you must: - Have a diagnosis of breast cancer that is now metastatic (meaning the cancer has spread beyond its original location) or a recurrence of the cancer in its original location that cannot be removed by surgery.
- Have received previous treatment with anthracyclines (e.g., adriamycin, Doxorubicin) and taxanes (e.g., paclitaxel, docetaxel, Taxol®, Taxotere®) for your breast cancer and your doctor has determined that these treatment are no longer of benefit to you.
- Be at least 18 years of age.
- Not be taking other treatments for your cancer at the time you enter this trial.
- Not be pregnant.
Additionally, there are other criteria for study entry that a doctor participating in this study will need to review in detail with you and clinical assessments may need to be performed (e.g., lab tests, CT scans).
Trial Contact Information
Trial Lead Organizations/Sponsors Sanofi-Aventis - US - Bridgewater
Trial Sites
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| Alabama |
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Birmingham |
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| Arizona |
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Tucson |
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| Arkansas |
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Little Rock |
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| California |
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Bakersfield |
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Burbank |
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Concord |
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Fountain Valley |
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Fresno |
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Fullerton |
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Gilroy |
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Long Beach |
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Monterey Park |
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Northridge |
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Oxnard |
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Pamona |
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Pomona |
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Porterville |
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Redondo Bech |
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San Diego |
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San Francisco |
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Santa Barbara |
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Vista |
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| Connecticut |
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New London |
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| Delaware |
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Newark |
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| Florida |
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Fort Lauderdale |
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Gainsville |
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Jacksonville |
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Lake Worth |
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Orlando |
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West Palm Beach |
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| Georgia |
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Lawrenceville |
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Macon |
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Marietta |
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Roswell |
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| Illinois |
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Centralia |
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Chicago |
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Peoria |
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Skokie |
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| Indiana |
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Fort Wayne |
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New Albany |
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| Kentucky |
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Danville |
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Hazard |
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Lexington |
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| Louisiana |
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Lafayette |
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Shreveport |
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| Maryland |
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Annapolis |
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Baltimore |
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| Michigan |
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Southfield |
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St. Joseph |
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| Missouri |
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St. Louis |
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| Montana |
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Billings |
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| New Jersey |
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Hackensack |
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| New York |
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Binghamton |
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Nyack |
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Utica |
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| North Carolina |
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Chapel Hill |
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Charlotte |
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Greenville |
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Raleigh |
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Wilmington |
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Winston Salem |
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| North Dakota |
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Bismarck |
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| Ohio |
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Cincinatti |
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Cleveland |
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Worthington |
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| Pennsylvania |
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Dunmore |
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Hershey |
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Kingston |
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Philadelphia |
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Pittsburgh |
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| South Carolina |
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Charleston |
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Greenville |
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| Tennessee |
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Nashville |
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| Texas |
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Dallas |
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Fort Worth |
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Richardson |
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| Virginia |
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Abingdon |
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Arlington |
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| Washington |
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Kirkland |
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Spokane |
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| West Virginia |
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Huntington |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00081796
Information obtained from ClinicalTrials.gov on 2005-03-14 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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