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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

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)

October 13, 2016

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

January 19, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Actual)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 12, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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