Compassionate Use of Eribulin for the Treatment of Advanced Breast Cancer Refractory to All Other Marketed Therapies

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Eribulin Mesylate

• Registration Number: NCT01142661
• Lead Sponsor: Eisai Inc.

Brief Summary

The purpose of this study is to provide eribulin to patients with advanced breast cancer who have no other treatment options and therapy is requested by an Investigator.

Detailed Description

This compassionate use program will consist of a Pretreatment Phase and a Treatment Phase. Patients with locally advanced or metastatic breast cancer who fulfill the eligibility criteria may be treated. Safety data will be collected, but a minimal amount of other data will also be collected.

Study Timeline

• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Study Start: 2010-08
• Primary Completion: 2011-08
• Results First Submitted: 2013-04-29
• Status Verified: 2013-09
• Results First Submitted QC: 2013-09-19
• Last Update Submitted: 2013-09-19
• Results First Posted: 2013-09-20
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eribulin mesylate	Eribulin Mesylate	-

Primary Outcome Measures

Name	Time	Method
Safety	For duration of treatment, an average of 5 months	General safety will be assessed by monitoring and recording the number of patients with serious adverse events for duration of treatment which continued until disease progression, unacceptable toxicity or death.