Clinical trial · Observational
Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy
Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy (IRENE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced or Metastatic Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eribulin | Drug | Eribulin | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Eribulin-treated participants
- description
- Participants treated with eribulin according to Fachinformation and managed according to clinical practice
- interventionNames
- Drug: Eribulin
Primary outcomes (10)
- measure
- Number of participants experiencing eribulin-induced peripheral neuropathy (PN)
- timeFrame
- Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
- measure
- Percentage of participants experiencing eribulin-induced PN
- timeFrame
- Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available