Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy

Study Overview
=================
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.

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

Conditions
-----------------
Locally Advanced or Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: Eribulin


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eribulin-treated participants<br>Participants treated with eribulin according to Fachinformation and managed according to clinical practice | Drug: Eribulin<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants experiencing eribulin-induced peripheral neuropathy (PN) |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 | 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 | 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 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 |  | 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 |  | 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 |  | Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first | 
| Time to disease progression | 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 |  | 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 |  | Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
locally advanced or metastatic breast cancer, peripheral neuropathy, chemotherapy-induced peripheral neuropathy, eribulin