Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy

Locally Advanced or Metastatic Breast Cancer Clinical Trial

— IRENE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027245
• Other study ID #: E7389-M044-504
• Status: Completed
• Start date: October 13, 2016
• Est. completion date: May 31, 2022

Study information

• Verified date: March 2022
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced or Metastatic Breast Cancer
• Peripheral Nervous System Diseases

Intervention

Drug:
• Eribulin

Locations

Country	Name	City	State
Germany	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	Eisai Trial Site 2	Bonn
Germany	Eisai Trial Site 1	Darmstadt
Germany	Eisai Trial Site 1	Donauworth
Germany	EISAI Trial Site 1	Dresden
Germany	Eisai Trial Site 1	Duren
Germany	Eisai Trial Site 1	Essen
Germany	Eisai Trial Site 1	Esslingen
Germany	Eisai Trial Site 1	Eutin
Germany	Eisai Trial Site 1	Freiburg
Germany	Eisai Trial Site 1	Furstenwalde
Germany	Eisai Trial Site 1	Gelsenkirchen
Germany	Eisai Trial Site 1	Georgsmarienhütte
Germany	Eisai Trial Site 1	Greifswald
Germany	Eisai Trial Site 1	Hannover
Germany	Eisai Trial Site 2	Hannover
Germany	Eisai Trial Site 1	Hof
Germany	Eisai Trial Site 1	Homburg
Germany	Eisai Trial Site 1	Ilsede
Germany	Eisai Trial Site 1	Karlsruhe
Germany	Eisai Trial Site 1	Kassel
Germany	Eisai Trial Site 1	Kiel
Germany	Eisai Trial Site 2	Kiel
Germany	Eisai Trial Site 1	Koblenz
Germany	Eisai Trial Site 1	Koln
Germany	Eisai Trial Site 2	Koln
Germany	Eisai Trial Site 1	Lahr
Germany	Eisai Trial Site 1	Landshut
Germany	Eisai Trial Site 1	Lemgo
Germany	Eisai Trial Site 1	Lubeck
Germany	Eisai Trial Site 1	Magdeburg
Germany	Eisai Trial Site 1	Mainz
Germany	Eisai Trial Site 1	Mannheim
Germany	Eisai Trial Site 1	Marktredwitz
Germany	Eisai Trial Site 1	Munchen
Germany	Eisai Trial Site 2	Munchen
Germany	Eisai Trial Site 3	Munchen
Germany	Eisai Trial Site 1	Munster
Germany	Eisai Trial Site 1	Münster
Germany	Eisai Trial Site 1	Naunhof
Germany	Eisai Trial Site 1	Nurnberg
Germany	Eisai Trial Site 1	Oberhausen
Germany	Eisai Trial Site 1	Offenbach
Germany	Eisai Trial Site 1	Offenburg
Germany	Eisai Trial Site 1	Oldenburg
Germany	Eisai Trial Site 1	Potsdam
Germany	Eisai Trial Site 1	Puttlingen
Germany	Eisai Trial Site 1	Quedlinburg
Germany	Eisai Trial Site 1	Rodgau
Germany	Eisai Trial Site 1	Rotenburg
Germany	Eisai Trial Site 1	Saarlouis
Germany	Eisai Trial Site 1	Stolberg
Germany	Eisai Trial Site 1	Stuttgart
Germany	Eisai Trial Site 2	Stuttgart
Germany	Eisai Trial Site 1	Tubingen
Germany	Eisai Trial Site 1	Villingen-Schwenningen
Germany	Eisai Trial Site 1	Worms

Sponsors (1)

Lead Sponsor	Collaborator
Eisai GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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