| April 20, 2004 |
| August 20, 2008 |
| April 2004 |
| September 2006 (final data collection date for primary outcome measure) |
| Time to tumor progression. |
| Same as current |
| Complete list of historical versions of study NCT00081796 on ClinicalTrials.gov Archive Site |
| Overall survival. |
| Same as current |
| |
| Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer |
| 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. |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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- Drug: larotaxel (RPR109881, XRP9881)
- Drug: capecitabine
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| |
| |
| |
| Completed |
| 438 |
| September 2006 |
| September 2006 (final data collection date for primary outcome measure) |
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). |
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| 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 |
| |
| NCT00081796 |
| ICD Study Director, sanofi-aventis |
| EFC6089, XRP9881B-3001 |
| Sanofi-Aventis |
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| Study Director: |
ICD CSD |
Sanofi-Aventis |
|
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| Sanofi-Aventis |
| August 2008 |