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

Eisai

Status

Completed

Conditions

Locally Advanced or Metastatic Breast Cancer

Treatments

Drug: Eribulin

Study type

Observational

Funder types

Industry

Identifiers

NCT03027245

E7389-M044-504

Details and patient eligibility

About

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.

Enrollment

353 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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