NCT02225470

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 530 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HER2-Negative Breast Cancer
• Triple Negative Breast Cancer
• Breast Cancer
• Cancer of Breast
• Breast Tumors

Interventions

Type	Name	Description
DRUG	E7389 (Eribulin Mesylate)
DRUG	Vinorelbine injection

Timeline

• Start date: 2013-09-26
• Primary completion: 2017-09-29
• Completion: 2018-06-22
• First posted: 2014-08-26
• Last updated: 2018-08-28

Locations

35 sites across 1 country: China