Eisai Clinical Trials

An Open-label Randomized Parallel Two-arm Multicenter Study of Eribulin Versus Vinorelbine in Female Subjects With Locally Recurrent or Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane

E7389-C086-304

Study Overview

E7389
eribulin mesilate
NCT02225470
Sep 2013 - Jun 2018
Breast Cancer
1. Progression-Free Survival (PFS) of Eribulin Arm by tumor assessment : Time to disease progression [ Time Frame: Baseline until date of recorded disease progression or death, or up to 2 years ]
2. Progression-Free Survival (PFS) of Vinorelbine Arm by tumor assessment: Time to disease progression [ Time Frame: Baseline until date of recorded disease progression or death, or up to 2 years ]
3. Maximum observed plasma concentration (Cmax) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
4. Time at which the highest drug concentration occurs (tmax) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
5. Area under the plasma concentration-time curve (AUC) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
6. Terminal phase rate constant (lambda Z) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
7. Terminal elimination phase half-life (t1/2) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
8. Distribution volume at steady-state (Vss) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
9. Total clearance (CL) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]

  • Females (age 18 years to 70 years)

  • Completed

  • Phase 3

  • China

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Yuan P, Hu X, Sun T, Li W, Zhang Q, Cui S, et al. Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial. Eur J Cancer 2019 05;112:57-65.

Data Sharing

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Redacted documents are available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR