Clinical trial NCT03027245: Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy
Official title: Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy (IRENE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced or Metastatic Breast Cancer
Keywords: locally advanced or metastatic breast cancer
peripheral neuropathy
chemotherapy-induced peripheral neuropathy
eribulin
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-23
Enrollment: 353
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female participants greater than or equal to (\>=) 18 years with locally advanced or MBC

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.


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

Primary outcomes:
measure: Number of participants experiencing eribulin-induced peripheral neuropathy (PN)
timeFrame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Percentage of participants experiencing eribulin-induced PN
timeFrame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: 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
timeFrame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Percentage of participants who experienced dose modifications of eribulin treatment due to eribulin-induced PN
timeFrame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Percentage of participants who discontinued eribulin treatment due to eribulin-induced PN
timeFrame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Time to eribulin treatment discontinuation due to eribulin-induced PN
timeFrame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Number of resolved cases in participants who experience eribulin-induced PN
timeFrame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Percentage of resolved cases in participants who experience eribulin-induced PN
timeFrame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Time to resolution of eribulin-induced PN
timeFrame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Number of therapeutic interventions (e.g., analgesics) being used to treat eribulin-induced PN
timeFrame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Secondary outcomes:
measure: Health-related quality of life scores measured using the Patient Neurotoxicity Questionnaire
timeFrame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Health-related quality of life scores measured using the EuroQOl-5 Dimensions-3 Levels (EQ-5D-3L) questionnaire
timeFrame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Time to disease progression
timeFrame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Number of participants with any serious adverse event (SAE) and number of participants with any non-serious AE
timeFrame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
measure: Percentage of participants with any SAE and percentage of participants with any non-serious AE
timeFrame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Other outcomes:
Locations:
city: Amberg
country: Germany
facility: Eisai Trial Site 1
city: Aschaffenburg
country: Germany
facility: Eisai Trial Site 1
city: Aschaffenburg
country: Germany
facility: Eisai Trial Site 2
city: Augsburg
country: Germany
facility: Eisai Trial Site 1
city: Augsburg
country: Germany
facility: Eisai Trial Site 2
city: Aurich
country: Germany
facility: Eisai Trial Site 1
city: Berlin
country: Germany
facility: Eisai Trial Site 1
city: Berlin
country: Germany
facility: Eisai Trial Site 2
city: Berlin
country: Germany
facility: Eisai Trial Site 3
city: Bonn
country: Germany
facility: Eisai Trial Site 1
city: Bonn
country: Germany
facility: Eisai Trial Site 2
city: Darmstadt
country: Germany
facility: Eisai Trial Site 1
city: Donauworth
country: Germany
facility: Eisai Trial Site 1
city: Dresden
country: Germany
facility: EISAI Trial Site 1
city: Duren
country: Germany
facility: Eisai Trial Site 1
city: Essen
country: Germany
facility: Eisai Trial Site 1
city: Esslingen
country: Germany
facility: Eisai Trial Site 1
city: Eutin
country: Germany
facility: Eisai Trial Site 1
city: Freiburg
country: Germany
facility: Eisai Trial Site 1
city: Furstenwalde
country: Germany
facility: Eisai Trial Site 1
city: Gelsenkirchen
country: Germany
facility: Eisai Trial Site 1
city: Georgsmarienhütte
country: Germany
facility: Eisai Trial Site 1
city: Greifswald
country: Germany
facility: Eisai Trial Site 1
city: Hannover
country: Germany
facility: Eisai Trial Site 1
city: Hannover
country: Germany
facility: Eisai Trial Site 2
city: Hof
country: Germany
facility: Eisai Trial Site 1
city: Homburg
country: Germany
facility: Eisai Trial Site 1
city: Ilsede
country: Germany
facility: Eisai Trial Site 1
city: Karlsruhe
country: Germany
facility: Eisai Trial Site 1
city: Kassel
country: Germany
facility: Eisai Trial Site 1
city: Kiel
country: Germany
facility: Eisai Trial Site 1
city: Kiel
country: Germany
facility: Eisai Trial Site 2
city: Koblenz
country: Germany
facility: Eisai Trial Site 1
city: Koln
country: Germany
facility: Eisai Trial Site 1
city: Koln
country: Germany
facility: Eisai Trial Site 2
city: Lahr
country: Germany
facility: Eisai Trial Site 1
city: Landshut
country: Germany
facility: Eisai Trial Site 1
city: Lemgo
country: Germany
facility: Eisai Trial Site 1
city: Lubeck
country: Germany
facility: Eisai Trial Site 1
city: Magdeburg
country: Germany
facility: Eisai Trial Site 1
city: Mainz
country: Germany
facility: Eisai Trial Site 1
city: Mannheim
country: Germany
facility: Eisai Trial Site 1
city: Marktredwitz
country: Germany
facility: Eisai Trial Site 1
city: Munchen
country: Germany
facility: Eisai Trial Site 1
city: Munchen
country: Germany
facility: Eisai Trial Site 2
city: Munchen
country: Germany
facility: Eisai Trial Site 3
city: Munster
country: Germany
facility: Eisai Trial Site 1
city: Münster
country: Germany
facility: Eisai Trial Site 1
city: Naunhof
country: Germany
facility: Eisai Trial Site 1
city: Nurnberg
country: Germany
facility: Eisai Trial Site 1
city: Oberhausen
country: Germany
facility: Eisai Trial Site 1
city: Offenbach
country: Germany
facility: Eisai Trial Site 1
city: Offenburg
country: Germany
facility: Eisai Trial Site 1
city: Oldenburg
country: Germany
facility: Eisai Trial Site 1
city: Potsdam
country: Germany
facility: Eisai Trial Site 1
city: Puttlingen
country: Germany
facility: Eisai Trial Site 1
city: Quedlinburg
country: Germany
facility: Eisai Trial Site 1
city: Rodgau
country: Germany
facility: Eisai Trial Site 1
city: Rotenburg
country: Germany
facility: Eisai Trial Site 1
city: Saarlouis
country: Germany
facility: Eisai Trial Site 1
city: Stolberg
country: Germany
facility: Eisai Trial Site 1
city: Stuttgart
country: Germany
facility: Eisai Trial Site 1
city: Stuttgart
country: Germany
facility: Eisai Trial Site 2
city: Tubingen
country: Germany
facility: Eisai Trial Site 1
city: Villingen-Schwenningen
country: Germany
facility: Eisai Trial Site 1
city: Worms
country: Germany
facility: Eisai Trial Site 1
Study officials:
References: