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Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy | Clinical Trials | Clareo Health

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Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy

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

NCT03027245•Eisai GmbH

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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

Locations (65)

Eisai Trial Site 1

Amberg, Germany

Eisai Trial Site 1

Aschaffenburg, Germany

Eisai Trial Site 2

Aschaffenburg, Germany

Eisai Trial Site 1

Augsburg, Germany

Eisai Trial Site 2

Augsburg, Germany

Eisai Trial Site 1

Aurich, Germany

Eisai Trial Site 1

Berlin, Germany

Eisai Trial Site 2

Berlin, Germany

Eisai Trial Site 3

Berlin, Germany

Eisai Trial Site 1

Bonn, Germany

Key Dates

Start Date

October 13, 2016

Primary Completion Date

May 31, 2022

Completion Date

May 31, 2022

Last Updated

July 13, 2022

Enrollment

353

ACTUAL participants

Conditions

Locally Advanced or Metastatic Breast Cancer

Interventions

Eribulin

DRUG

A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)

NCT06680921

Locally Advanced or Metastatic Breast Cancer

View study

COMPLETEDPHASE3

A Phase III Trial of Pertuzumab Retreatment in Previously Pertuzumab Treated Her2-Positive Advanced Breast Cancer

NCT02514681

HER2-positive Locally Advanced or Metastatic Breast Cancer

View study

TERMINATEDPHASE1

Phase I Study of Ixabepilone Plus Lapatinib With or Without Capecitabine in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 13, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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