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A Randomized, Open-Label, Phase III Study of RPR109881 IV Every 3 Weeks Versus Capecitabine (Xeloda) Tablets Twice Daily for 2 Weeks in 3-Week Cycles in Patients With Metastatic Breast Cancer Progressing After Taxanes and Anthracycline Therapy
The purpose of this clinical trial is to determine if RPR109881 is a better treatment than capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from docetaxel and/or paclitaxel.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Birmingham, Alabama, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Bakersfield, California, United States
Burbank, California, United States
Concord, California, United States
Fountain Valley, California, United States
Fresno, California, United States
Fullerton, California, United States
Gilroy, California, United States
Start Date
April 1, 2004
Primary Completion Date
September 1, 2006
Completion Date
September 1, 2006
Last Updated
August 21, 2008
438
ACTUAL participants
larotaxel (RPR109881, XRP9881)
DRUG
capecitabine
DRUG
Lead Sponsor
Sanofi
NCT05692635
NCT05673200
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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