An Open-Label, Single-Arm Multicenter Phase 1b/2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Combination With Pembrolizumab in Subjects With Metastatic Triple-Negative Breast Cancer (mTNBC)

Eisai Clinical Trials

Protocol # E7389-M001-218

Study Overview

Study Compound: E7389

Drug Name: eribulin mesilate

Registry #: NCT02513472

Trial Period: Aug 2015 - Apr 2021

Indication: Breast Cancer

Primary Endpoint:
1. Objective Response Rate (ORR) [Time Frame: From date of first dose of study drug administration to date of first documentation of disease progression or death, whichever occurred first (up to 3 years 11 months)]

Population
Males and females 18 Years and older (Adult, Older Adult)
Study Status
Completed
Study Phase
Phase 1 / 2
Countries
United States

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Tolaney S, Kalinsky K, Kaklamani V, D’Adamo D, Aktan G, et al. A phase Ib/II study of eribulin (ERI) plus pembrolizumab (PEMBRO) in metastatic triple-negative breast cancer (mTNBC) (ENHANCE 1). J Clin Oncol 38: 2020 (suppl; abstr 1015).

Data Sharing

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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