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

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

Protocol # E7389-G000-305

Study Overview

Study Compound: E7389

Drug Name: eribulin mesilate

Registry #: NCT00388726, 2006-001949-34

Trial Period: Nov 2006 - Jun 2013

Indication: Breast Cancer

Primary Endpoint:
1. Overall Survival [ Time Frame: From date of randomization until death from any cause]

Population
Females 18 Years and older (Adult, Older Adult)
Study Status
Completed
Study Phase
Phase 3
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Croatia, Czechia, France, Hungary, Italy, Poland, Russian Federation, South Africa, Spain, Switzerland, United States See moreSee less

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

Miyoshi Y, Yoshimura Y, Saito K, Muramoto K, Sugawara M, Alexis K, Nomoto K, Nakamura S, Saeki T, Watanabe J, Perez-Garcia JM, Cortes J. High absolute lymphocyte counts are associated with longer overall survival in patients with metastatic breast cancer treated with eribulin-but not with treatment of physician’s choice-in the EMBRACE study. Breast Cancer. 2020 Jul;27(4):706-715. doi: 10.1007/s12282-020-01067-2. Epub 2020 Mar 5.

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