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Incidence and Resolution of E...

Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy

Last Updated: 2022-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

353 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-13

Study Completion Date

2022-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Locally Advanced or Metastatic Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Eribulin-treated participants

Participants treated with eribulin according to Fachinformation and managed according to clinical practice

Eribulin

Intervention Type DRUG

Interventions

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Eribulin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers