NCT00080301

Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

A Phase III Trial of Novel Epothilone BMS-247550 Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 752 (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 is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of this treatment will also be studied.

Conditions

• Breast Cancer
• Metastases

Interventions

Type	Name	Description
DRUG	Ixabepilone + Capecitabine	Ixabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity
DRUG	Capecitabine	Tablet, Oral, 2500 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity

Timeline

• Start date: 2003-09-01
• Primary completion: 2006-11-01
• Completion: 2008-03-01
• First posted: 2004-03-30
• Last updated: 2020-11-02
• Results posted: 2009-08-17

Locations

127 sites across 22 countries: United States, Argentina, Belgium, Brazil, Canada, China, France, Germany, Greece, Hungary, Italy, Malaysia, Mexico, Peru, Philippines, Poland, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom