Eisai Clinical Trials

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Eribulin Mesylate Administered Biweekly (Q2W) for Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer

E7389-M001-216

Study Overview

E7389
eribulin mesilate
NCT02481050
Jun 2015 - Sep 2017
HER2-Negative Metastatic Breast Cancer
1. Objective Response Rate (ORR) by Investigator Assessment [ Time Frame: From first dose of study drug until intercurrent illness, unacceptable toxicity, disease progression, or until the participant withdrew consent (approximately up to 2.3 years) ]

2. Disease Control Rate (DCR) by Investigator Assessment [ Time Frame: From first dose of study drug until intercurrent illness, unacceptable toxicity, disease progression, or until the participant withdrew consent (approximately up to 2.3 years) ]

  • Adult females (age 18+ years)

  • Completed

  • Phase 2

  • United States

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Smith J,II, Irwin A, Jensen L, Tedesco K, Misir S, Zhu W, et al. Phase II Study of Eribulin Mesylate
Administered Biweekly in Patients With Human Epidermal Growth Factor Receptor-2–negative Metastatic Breast Cancer. Clin Breast Cancer 2020 04;20(2):160-167.

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