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

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ClinicalTrials.gov Identifier: NCT03027245
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai GmbH )

Brief Summary:
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.

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

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy (IRENE)
Actual Study Start Date : October 13, 2016
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Eribulin-treated participants
Participants treated with eribulin according to Fachinformation and managed according to clinical practice
Drug: Eribulin



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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

  8. 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

  9. 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.

  10. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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)

  4. 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 ]
  5. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Female participants greater than or equal to (>=) 18 years with locally advanced or MBC
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT03027245


Contacts
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Contact: Helga Schmitz helga_schmitz@eisai.net

Locations
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Sponsors and Collaborators
Eisai GmbH
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Responsible Party: Eisai GmbH
ClinicalTrials.gov Identifier: NCT03027245    
Other Study ID Numbers: E7389-M044-504
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Eisai Inc. ( Eisai GmbH ):
locally advanced or metastatic breast cancer
peripheral neuropathy
chemotherapy-induced peripheral neuropathy
eribulin
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases