NCT00337103

E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes

A Phase III Open Label, Randomized Two-Parallel-Arm Multicenter Study of E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,276 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare E7389 versus capecitabine in patients with locally advanced or metastatic breast cancer who are refractory to the most recent chemotherapy. This is an open-label, randomized, two-parallel arm study. Patients will be randomized to receive either E7389 or capecitabine on a one-to-one ratio.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Eribulin Mesylate	1.4 mg/m\^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
DRUG	Capecitabine	Capecitabine 2.5 g/m\^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days

Timeline

• Start date: 2006-09-20
• Primary completion: 2012-03-12
• Completion: 2017-12-11
• First posted: 2006-06-15
• Last updated: 2020-06-18
• Results posted: 2013-09-30

Locations

169 sites across 23 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Poland, Romania, Russia, Singapore, South Africa, Spain, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study