Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy (IRENE)

July 12, 2022 updated by: Eisai GmbH

Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy (IRENE)

Study E7389-M044-504 is an observational, post-authorization, single-arm, prospective, multicenter cohort study conducted to characterize and determine the incidence of eribulin-induced peripheral neuropathy (PN), and the frequency and time to resolution of eribulin-induced PN in adult participants treated with eribulin in a real-life setting with locally advanced or metastatic breast cancer (MBC) who have progressed following at least one and up to three chemotherapeutic regimens for advanced disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
353

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Amberg, Germany
        • Eisai Trial Site 1
      • Aschaffenburg, Germany
        • Eisai Trial Site 1
      • Aschaffenburg, Germany
        • Eisai Trial Site 2
      • Augsburg, Germany
        • Eisai Trial Site 1
      • Augsburg, Germany
        • Eisai Trial Site 2
      • Aurich, Germany
        • Eisai Trial Site 1
      • Berlin, Germany
        • Eisai Trial Site 1
      • Berlin, Germany
        • Eisai Trial Site 2
      • Berlin, Germany
        • Eisai Trial Site 3
      • Bonn, Germany
        • Eisai Trial Site 1
      • Bonn, Germany
        • Eisai Trial Site 2
      • Darmstadt, Germany
        • Eisai Trial Site 1
      • Donauworth, Germany
        • Eisai Trial Site 1
      • Dresden, Germany
        • Eisai Trial Site 1
      • Duren, Germany
        • Eisai Trial Site 1
      • Essen, Germany
        • Eisai Trial Site 1
      • Esslingen, Germany
        • Eisai Trial Site 1
      • Eutin, Germany
        • Eisai Trial Site 1
      • Freiburg, Germany
        • Eisai Trial Site 1
      • Furstenwalde, Germany
        • Eisai Trial Site 1
      • Gelsenkirchen, Germany
        • Eisai Trial Site 1
      • Georgsmarienhütte, Germany
        • Eisai Trial Site 1
      • Greifswald, Germany
        • Eisai Trial Site 1
      • Hannover, Germany
        • Eisai Trial Site 1
      • Hannover, Germany
        • Eisai Trial Site 2
      • Hof, Germany
        • Eisai Trial Site 1
      • Homburg, Germany
        • Eisai Trial Site 1
      • Ilsede, Germany
        • Eisai Trial Site 1
      • Karlsruhe, Germany
        • Eisai Trial Site 1
      • Kassel, Germany
        • Eisai Trial Site 1
      • Kiel, Germany
        • Eisai Trial Site 1
      • Kiel, Germany
        • Eisai Trial Site 2
      • Koblenz, Germany
        • Eisai Trial Site 1
      • Koln, Germany
        • Eisai Trial Site 1
      • Koln, Germany
        • Eisai Trial Site 2
      • Lahr, Germany
        • Eisai Trial Site 1
      • Landshut, Germany
        • Eisai Trial Site 1
      • Lemgo, Germany
        • Eisai Trial Site 1
      • Lubeck, Germany
        • Eisai Trial Site 1
      • Magdeburg, Germany
        • Eisai Trial Site 1
      • Mainz, Germany
        • Eisai Trial Site 1
      • Mannheim, Germany
        • Eisai Trial Site 1
      • Marktredwitz, Germany
        • Eisai Trial Site 1
      • Munchen, Germany
        • Eisai Trial Site 1
      • Munchen, Germany
        • Eisai Trial Site 2
      • Munchen, Germany
        • Eisai Trial Site 3
      • Munster, Germany
        • Eisai Trial Site 1
      • Münster, Germany
        • Eisai Trial Site 1
      • Naunhof, Germany
        • Eisai Trial Site 1
      • Nurnberg, Germany
        • Eisai Trial Site 1
      • Oberhausen, Germany
        • Eisai Trial Site 1
      • Offenbach, Germany
        • Eisai Trial Site 1
      • Offenburg, Germany
        • Eisai Trial Site 1
      • Oldenburg, Germany
        • Eisai Trial Site 1
      • Potsdam, Germany
        • Eisai Trial Site 1
      • Puttlingen, Germany
        • Eisai Trial Site 1
      • Quedlinburg, Germany
        • Eisai Trial Site 1
      • Rodgau, Germany
        • Eisai Trial Site 1
      • Rotenburg, Germany
        • Eisai Trial Site 1
      • Saarlouis, Germany
        • Eisai Trial Site 1
      • Stolberg, Germany
        • Eisai Trial Site 1
      • Stuttgart, Germany
        • Eisai Trial Site 1
      • Stuttgart, Germany
        • Eisai Trial Site 2
      • Tubingen, Germany
        • Eisai Trial Site 1
      • Villingen-Schwenningen, Germany
        • Eisai Trial Site 1
      • Worms, Germany
        • Eisai Trial Site 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Female participants greater than or equal to (>=) 18 years with locally advanced or MBC

Description

Inclusion Criteria:

  • Locally advanced or MBC with progression after at least one chemotherapeutic regimen for advanced disease eligible for treatment with eribulin according to Fachinformation. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless participants were not suitable for these treatments
  • 1-3 prior chemotherapeutic regimens for advanced disease
  • Age >=18 years at the time of Informed Consent
  • Ability to understand and willingness to respond to questions related to their health
  • Decision for the participant to start treatment with eribulin has been made prior to inclusion in this study.
  • Signed written Informed Consent

Exclusion Criteria:

  • Previous treatment with eribulin in any line of treatment
  • Contraindication according to the Fachinformation of eribulin
  • Pregnancy or lactation
  • Participation in an interventional clinical trial at the same time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Eribulin-treated participants
Participants treated with eribulin according to Fachinformation and managed according to clinical practice
Drug: Eribulin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants experiencing eribulin-induced peripheral neuropathy (PN)
Time Frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Percentage of participants experiencing eribulin-induced PN
Time Frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Number of participants with the indicated grade of eribulin-induced PN, as determined by Common Terminology Criteria for Adverse Events (CTCAE), grade version 4.0
Time Frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Percentage of participants who experienced dose modifications of eribulin treatment due to eribulin-induced PN
Time Frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Percentage of participants who discontinued eribulin treatment due to eribulin-induced PN
Time Frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Time to eribulin treatment discontinuation due to eribulin-induced PN
Time Frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Number of resolved cases in participants who experience eribulin-induced PN
Time Frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
A resolved case is defined as one that ended or returned to baseline as determined by CTCAE grade version 4.0
Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Percentage of resolved cases in participants who experience eribulin-induced PN
Time Frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
A resolved case is defined as one that ended or returned to baseline as determined by CTCAE grade version 4.0
Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Time to resolution of eribulin-induced PN
Time Frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Time to resolution is defined as the time from onset (or worsening from baseline) to the date of resolution (defined as stop of PN or return to baseline), as determined by CTCAE grade version 4.0.
Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Number of therapeutic interventions (e.g., analgesics) being used to treat eribulin-induced PN
Time Frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health-related quality of life scores measured using the Patient Neurotoxicity Questionnaire
Time Frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Health-related quality of life scores measured using the EuroQOl-5 Dimensions-3 Levels (EQ-5D-3L) questionnaire
Time Frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Time to disease progression
Time Frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Time to disease progression is defined as the time from the start of eribulin treatment to Investigator assessment of disease progression (clinical or radiological)
Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Number of participants with any serious adverse event (SAE) and number of participants with any non-serious AE
Time Frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Percentage of participants with any SAE and percentage of participants with any non-serious AE
Time Frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E7389-M044-504

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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