CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,276 enrolled
Drug / intervention
Eribulin Mesylate +1 moredrug
Likely dose
Eribulin Mesylate 1.4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00337103
NCT00337103Phase 3Completed
CompareCT.gov

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

Eisai Inc.·interventional·Posted Jun 15, 2006·Updated Jun 18, 2020

In Brief

A Phase 3 clinical trial evaluating Eribulin Mesylate and Capecitabine for Metastatic Breast Cancer. Completed, enrolled 1,276 participants across 169 sites in 23 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Poland, Romania, Russia, Singapore, South Africa, Spain, Taiwan, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 15, 2006
Enrollment StartSep 20, 2006
Primary CompletionMar 12, 2012
Study CompletionDec 11, 2017
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 20.0 years ago

Interventions

Eribulin Mesylatedrug

1.4 mg/m\^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days

Capecitabinedrug

Capecitabine 2.5 g/m\^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days