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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.
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 438 |
| Start date | 2004-04 |
| Completion | 2006-09 |
Conditions
- Breast Cancer
- Metastases
Interventions
- larotaxel (RPR109881, XRP9881)
- capecitabine
Primary outcomes
- Time to tumor progression.
Countries
United States, Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Mexico, New Zealand, Poland, Portugal, Romania, Slovenia, South Africa, South Korea, Spain, Taiwan, United Kingdom