Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer
Tracking Information | |||||
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First Received Date ICMJE | April 20, 2004 | ||||
Last Updated Date | August 20, 2008 | ||||
Start Date ICMJE | April 2004 | ||||
Primary Completion Date | September 2006 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Time to tumor progression. | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00081796 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Overall survival. | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | 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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Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 438 | ||||
Completion Date | September 2006 | ||||
Primary Completion Date | September 2006 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Eligibility Criteria In order to be eligible for this trial you must:
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). |
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States, Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Czech Republic, Finland, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Mexico, New Zealand, Poland, Portugal, Romania, Slovenia, South Africa, Spain, Taiwan, United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00081796 | ||||
Other Study ID Numbers ICMJE | EFC6089, XRP9881B-3001 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | ICD Study Director, sanofi-aventis | ||||
Study Sponsor ICMJE | Sanofi-Aventis | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Sanofi-Aventis | ||||
Verification Date | August 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |