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, 2005-004009-26
Sep 2006 - Dec 2017
Breast Cancer

1. 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]

2. Progression Free Survival (PFS) [Time Frame: From date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date of 12 Mar 2012 or up to approximately 6 years]

  • Females 18 Years and older (Adult, Older Adult)

  • Completed

  • Phase 3

  • Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Croatia, Czechia, France, Germany, Greece, Hungary, Israel, Italy, 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

Twelves C, Awada A, Cortes J, Yelle L, Velikova G, Olivo MS, Song J, Dutcus CE, Kaufman PA. Subgroup Analyses from a Phase 3, Open-Label, Randomized Study of Eribulin Mesylate Versus Capecitabine in Pretreated Patients with Advanced or Metastatic Breast Cancer. Breast Cancer (Auckl). 2016 Jun 28;10:77-84. doi: 10.4137/BCBCR.S39615. eCollection 2016.

Cortes J, Hudgens S, Twelves C, Perez EA, Awada A, Yelle L, McCutcheon S, Kaufman PA, Forsythe A, Velikova G. Health-related quality of life in patients with locally advanced or metastatic breast cancer treated with eribulin mesylate or capecitabine in an open-label randomized phase 3 trial. Breast Cancer Res Treat. 2015 Dec;154(3):509-20. doi: 10.1007/s10549-015-3633-7. Epub 2015 Nov 14.

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.

CSDR Sharing is available for this study.

CSDR Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR