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APPROVED_FOR_MARKETING

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

NCT01240421•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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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:
•1. Anthracyclines, taxanes, and capecitabine
•2. Ixabepilone, in countries where this agent is marketed
•3. Trastuzumab, for Her-2 positive disease
•4. Hormonal therapy, in hormone receptor-positive disease
•5. 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
+6 more criteria

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.
+3 more criteria

Locations (14)

Brussels, Belgium

Edmonton, Canada

London, Canada

Moncton, Canada

Montreal, Canada

Ottawa, Canada

Québec, Canada

Toronto, Canada

Vancouver, Canada

Besançon, France

Key Dates

Start Date

March 1, 2011

Primary Completion Date

March 1, 2015

Completion Date

November 1, 2014

Last Updated

May 22, 2015

Conditions

Metastatic Breast Cancer

Interventions

Eribulin Mesylate

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 22, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

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A Study Comparing Cancer Imaging Approaches in People With Lobular Breast Cancer

A Study of Surgery and Radiotherapy in People With Breast Cancer