NCT00082433

Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

A Phase III Study of Novel Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With an Anthracycline and a Taxane

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,221 (actual)
• Sponsor: R-Pharm · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this treatment will also be studied.

Conditions

• Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Ixabepilone + Capecitabine	Ixabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle
DRUG	Capecitabine	Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle

Timeline

• Start date: 2003-11-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2004-05-11
• Last updated: 2020-11-02
• Results posted: 2009-08-17

Locations

186 sites across 29 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, Portugal, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom