drugset / Trial / NCT01240421

An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer Refractory

NCT01240421

Expanded access Approved for marketing Eisai Inc.

Summary

This expanded access program is an open-label, multi-center study, which will consist of a PreTreatment Phase and a Treatment Phase. Patients with locally advanced or metastatic breast cancer who fulfill the eligibility criteria will be treated. The program will continue in each country until eribulin is approved, reimbursed and launched in that country, or termination of the program by the Sponsor.

Timeline

Start
2011-03
Primary completion
2015-03
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Eribulin Small molecule 1.4 mg/m2 Intravenous

Indications