NCT01961544

Eribulin Mesylate Phase IV Clinical Trial in Korean Patients With Metastatic or Locally Advanced Breast Cancer

Phase IV Clinical Trial to Evaluate Safety of Eribulin in Patients With Locally Advanced or Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Eisai Korea Inc. · Industry
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of eribulin which is approved for the treatment of the patients in Korea with locally advanced or metastatic breast cancer who had received two to five prior chemotherapy regimens including anthracyclines and taxanes for advanced disease. Subjects who meet the inclusion/exclusion criteria are administered of 1.4 mg/m2 of the investigational product intravenously in 2-5 min on day 1 and day 8 of every 21-day cycle. In case of the progression of disease, unacceptable toxicity, withdrawal of the consent, or judgment by investigator that the treatment needs to be stopped, the treatment of investigational product is stopped, and treatment termination assessment is performed within 30 days from the last treatment.

Conditions

• Breast Neoplasms
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Eribulin mesylate	1.4 mg/m2 (as eribulin 1.23 mg/m2) day by 2-5 minutes IV on Day 1 and 8 every 21 days

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2013-10-11
• Last updated: 2016-10-07
• Results posted: 2016-10-07

Locations

14 sites across 1 country: South Korea