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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01240421
Expanded Access Status : Approved for marketing
First Posted : November 15, 2010
Last Update Posted : May 22, 2015
Information provided by (Responsible Party):
Eisai Inc.

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.

Condition or disease Intervention/treatment
Metastatic Breast Cancer Drug: Eribulin Mesylate

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Study Type : Expanded Access
Official Title: An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer Refractory
Study Start Date : March 2011
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Intervention Details:
  • Drug: Eribulin Mesylate
    At a dose of 1.4 mg/m2 as a 2 to 5 minute intravenous bolus on Days 1 and 8 of a 21-day cycle.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female

Key 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
  • Adequate bone marrow function: absolute neutrophil count greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10 g/dL (can be corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10^9/L
  • Adequate liver function: total bilirubin less than or equal to 1.5 x upper limit of normal (ULN), alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase less than or equal to 3 x ULN (or less than or equal to 5 x ULN in case of liver metastases). If alkaline phosphatase is greater than 3 x ULN (in absence of liver metastases) or greater than 5 x ULN (in presence of liver metastases) AND patient also is known to have bone metastases, the liver specific alkaline phosphatase must be used to assess liver function instead of total alkaline phosphatase
  • Willing and able to comply with all aspects of the treatment protocol
  • Provision of written informed consent
  • Female, aged at least 18 years
  • Patients of childbearing potential must agree to be abstinent or to use a highly effective method of contraception

Key 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.
  • Meningeal carcinomatosis
  • Pulmonary lymphangitic involvement resulting in pulmonary dysfunction requiring active treatment, including use of oxygen
  • Receipt of any of the following treatments within the specified period before the start of treatment: 1) Any investigational drug within 4 weeks; 2) Chemotherapy, radiation, biological or targeted therapy within 2 weeks; 3) Hormonal therapy within 1 week.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01240421

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Brussels, Belgium
Edmonton, Canada
London, Canada
Moncton, Canada
Montreal, Canada
Ottawa, Canada
Quebec, Canada
Toronto, Canada
Vancouver, Canada
Besancon, France
Marseille Cedex 09, France
Paris Cedex 05, France
Saint-cloud, France
Toulouse cedex, France
Sponsors and Collaborators
Eisai Inc.
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Responsible Party: Eisai Inc. Identifier: NCT01240421    
Other Study ID Numbers: E7389-G000-398
First Posted: November 15, 2010    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015
Keywords provided by Eisai Inc.:
Metastatic breast cancer with no other treatment options
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases