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Completed

NCT Number: NCT03027245

Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy

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.

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Key information

Conditions

Locally Advanced or Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Eisai Trial Site 1, Amberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eribulin

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Eisai GmbH

Industry

Registry information

Official study title

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

Acronym: IRENE

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jan 23, 2017
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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