Eisai Clinical Trials

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

E7389-G000-301

Study Overview

E7389
eribulin mesilate
NCT00337103, EU CTR 2005-004009-26
Sep 2006 - Dec 2017
Breast Cancer
Overall Survival (OS) [ Time Frame: From date of randomization until date of death from any cause, assessed up to data cutoff date of 12 Mar 2012, or up to approximately 6 years ]

  • Adult females (age 18+ years)

  • Completed

  • Phase 3

  • Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Czech Republic, France, Germany, Greece, Hungary, Israel, Mexico, Poland, Romania, Russian Federation, Singapore, South Africa, Spain, Taiwan, Ukraine, United States See more

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, et al. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol 2015 Feb 20;33(6):594-601.

Data Sharing

ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.

Redacted documents are available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR