AzTrials
AzTrials

Metastatic Breast CancerNCT01240421

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

A study testing Eribulin Mesylate in people with Metastatic Breast Cancer, run by Eisai Inc. at 14 sites in 3 countries.

Approved For Marketing

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Eribulin Mesylate
Type of treatment
Injection or infusion
How many people
Not given
Where
14 sitesin 3 countries
Study dates
Mar 2011to Nov 2014
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

14 sites in 3 countries.

14 sites in 3 countries

Canada8 sites

  • Study site

    Edmonton

  • Study site

    London

  • Study site

    Moncton

  • Study site

    Montreal

  • Study site

    Ottawa

  • Study site

    Québec

  • Study site

    Toronto

  • Study site

    Vancouver

Other trials in Canada

France5 sites

  • Study site

    Besançon

  • Study site

    Marseille

  • Study site

    Paris

  • Study site

    Saint-Cloud

  • Study site

    Toulouse

Other trials in France

Belgium1 site

  • Study site

    Brussels

Other trials in Belgium

About this study

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.

Being tested
Eribulin Mesylate
Keywords
Metastatic breast cancer with no other treatment options
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eribulin MesylateDrug

    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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2010 (estimated)
  2. Study startMar 2011
  3. Primary completionMar 2015 (estimated)
  4. Study completionNov 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT01240421
Sponsor's protocol ID
E7389-G000-398
Status last verified
May 2015
First submitted
1 Oct 2010
Last updated
22 May 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Eribulin Mesylate in people with Metastatic Breast Cancer, run by Eisai Inc. at 14 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Canada, France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01240421.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in