Eisai Clinical Trials

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)

E7389-M001-218

Study Overview

E7389
eribulin mesilate
NCT02513472
Aug 2015 -
Metastatic Triple-Negative Breast Cancer
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 or up to data cutoff date of 31 July 2019 (up to approximately 3 years 11 months) ]

  • Males and females (age 18 years and over)

  • Active, not recruiting

  • Phase 1 / 2

  • 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

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