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

Eisai Inc.0 sitesMarch 2011

ConditionsMetastatic Breast Cancer

DrugsEribulin Mesylate

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Metastatic Breast Cancer
Sponsor: Eisai Inc.
Status: Approved For Marketing
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

November 2014

Last Updated

10 years ago

Study Type

Expanded Access

Sex

Female

Investigators

Sponsor

Eisai Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient's oncologist must have documented experience in a prior eribulin clinical trial
•Recurrent, locally advanced or metastatic breast cancer that has progressed on or after the last anti-cancer therapy
•Prior treatment with, ineligibility for, or commercial unavailability of each of the following therapies:
•Anthracyclines, taxanes, and capecitabine
•Ixabepilone, in countries where this agent is marketed
•Trastuzumab, for Her-2 positive disease
•Hormonal therapy, in hormone receptor-positive disease
•All other commercially available therapies, e.g. gemcitabine or vinorelbine, used for the treatment of advanced breast cancer (see NCCN guidelines)
•ECOG performance status greater than or equal to 2
•Adequate kidney function: serum creatinine less than or equal to 2.0 mg/dL or creatinine clearance greater than or equal to 40 mL/min

Exclusion Criteria

•Eligibility for any other eribulin study open in the same region
•Existing anti-cancer therapy-related toxicities of grade 2 or more, except that alopecia and grade 2 neuropathy are acceptable
•History of congestive heart failure with New York Heart Association Classification greater than grade II, unstable angina, myocardial infarction within the past 6 months or serious cardiac arrhythmia
•Electrocardiogram with QTc interval of greater than or equal to 500 msec based upon Bazett's formula (QTcB)
•The Investigator believes the patient to be medically unfit to receive eribulin or unsuitable for any other reason
•Pregnancy (positive B-hCG test) or breastfeeding
•Hypersensitivity to eribulin or any of the excipients
•Brain or subdural metastases, unless local therapy has been completed and use of corticosteroids for this indication has been discontinued for at least 4 weeks before starting treatment in this protocol. Any signs (eg, radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks before starting the treatment protocol
•History of or concomitant medical condition that, in the opinion of the Investigator, would compromise the patient's ability to safely complete the treatment protocol
•Known human immunodeficiency virus positivity, as neutropenia caused by eribulin treatment may make such patients particularly susceptible to infection.