NCT00081796

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 438 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Breast Cancer
• Metastases

Interventions

Type	Name	Description
DRUG	larotaxel (RPR109881, XRP9881)
DRUG	capecitabine

Timeline

• Start date: 2004-04-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2004-04-22
• Last updated: 2008-08-21

Locations

187 sites across 26 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