Eisai Clinical Trials

The “EMBRACE” Trial: Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice Versus E7389. A Phase III Open-Label, Randomized, Parallel, Two-arm, Multi-center Study of E7389 Versus “Treatment of Physician’s Choice” in Patients With Locally Recurrent, Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane

E7389-G000-305

Study Overview

E7389
eribulin mesilate
NCT00388726, EU CTR 2006-001949-34
May 2009 - Jun 2013
Breast Cancer
Overall Survival [ Time Frame: From date of randomization until death from any cause ]
Defined as the time from the date of randomization until the date of death from any cause.

  • Adult females (age 18+ years)

  • Completed

  • Phase 3

  • Argentina, Australia, Austria, Belgium, Brazil, Canada, Croatia (Hrvatska), Czechia, France, Hungary, Italy, Poland, Russian Federation, South Africa, Spain, Switzerland, United States See more

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Cortes J, O’Shaughnessy J, Loesch D, Twelves C, EMBRACE Eisai MB. Eribulin monotherapy versus
treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet 2011;377(9769):914-923.

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