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

Eisai Clinical Trials

Protocol # E7389-M001-216

Study Overview

Study Compound: E7389

Drug Name: eribulin mesilate

Registry #: NCT02481050

Trial Period: Jun 2015 - Sep 2017

Indication: Breast Cancer

Primary Endpoint: 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) ]

Population
Females 18 Years and older (Adult, Older Adult)
Study Status
Completed
Study Phase
Phase 2
Countries
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

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CSDR	Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type	Availability
Protocol
SAP
Sample CRF
Full CSR