NCT Number: NCT00081796
Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Buenos Aires, Argentina
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
Capecitabine
DrugPrimary outcomes
-
Time to tumor progression.
Secondary outcomes
-
Overall survival.
Sponsors and collaborators
Lead sponsor
Sanofi
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2004
- Primary completion
- 2006
- Study completion
- 2006
- First posted
- Apr 22, 2004
- Registry last updated
- Aug 21, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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