drugset / Trial / NCT02225470

Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes

NCT02225470

Phase 3 Completed 530 enrolled Eisai Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is designed as an open-label randomized parallel two-arm multicenter efficacy, pharmacokinetics and safety study of intravenously administered eribulin versus intravenously administered vinorelbine in Chinese population. Eligible female subjects will have measurable disease according to RECIST 1.1 with the modification that chest x-ray cannot be used for assessment of disease.

Timeline

Start
2013-09-26
Primary completion
2017-09-29
Completion
2018-06-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Eribulin Small molecule 1.4 mg/m2 Intravenous
Comparator Vinorelbine Small molecule 25 mg/m2 Intravenous