Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy

NCT03027245 | Completed DMC

• 1 other identifier: E7389-M044-504
• Study Type: observational
• Target: 353
• Locations: 1 country
• Sites: 65

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.

Conditions

Locally Advanced or Metastatic Breast Cancer

Keywords

locally advanced or metastatic breast cancer; peripheral neuropathy; chemotherapy-induced peripheral neuropathy; eribulin

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• 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

• 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

• Time to disease progression

  Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first

• 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

• 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

Study Arms (1)

Eribulin-treated participants

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

Drug: Eribulin

Interventions

Eribulin DRUG

Eribulin-treated participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female participants greater than or equal to (\>=) 18 years with locally advanced or MBC

You may qualify if:

• 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
• 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
• Signed written Informed Consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai GmbH: lead

Study Sites (65)

Eisai Trial Site 1

Amberg, Germany

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Eisai Trial Site 1

Aschaffenburg, Germany

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Eisai Trial Site 2

Aschaffenburg, Germany

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Eisai Trial Site 1

Augsburg, Germany

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Eisai Trial Site 2

Augsburg, Germany

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Eisai Trial Site 1

Aurich, Germany

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Eisai Trial Site 1

Berlin, Germany

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Eisai Trial Site 2

Berlin, Germany

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Eisai Trial Site 3

Berlin, Germany

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Eisai Trial Site 1

Bonn, Germany

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Eisai Trial Site 2

Bonn, Germany

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Eisai Trial Site 1

Cologne, Germany

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Eisai Trial Site 2

Cologne, Germany

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Eisai Trial Site 1

Darmstadt, Germany

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Eisai Trial Site 1

Donauwörth, Germany

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EISAI Trial Site 1

Dresden, Germany

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Eisai Trial Site 1

Düren, Germany

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Eisai Trial Site 1

Essen, Germany

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Eisai Trial Site 1

Esslingen am Neckar, Germany

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Eisai Trial Site 1

Eutin, Germany

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Eisai Trial Site 1

Freiburg im Breisgau, Germany

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Eisai Trial Site 1

Fürstenwalde, Germany

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Eisai Trial Site 1

Gelsenkirchen, Germany

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Eisai Trial Site 1

Georgsmarienhütte, Germany

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Eisai Trial Site 1

Greifswald, Germany

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Eisai Trial Site 1

Hanover, Germany

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Eisai Trial Site 2

Hanover, Germany

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Eisai Trial Site 1

Hof, Germany

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Eisai Trial Site 1

Homburg, Germany

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Eisai Trial Site 1

Ilsede, Germany

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Eisai Trial Site 1

Karlsruhe, Germany

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Eisai Trial Site 1

Kassel, Germany

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Eisai Trial Site 1

Kiel, Germany

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Eisai Trial Site 2

Kiel, Germany

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Eisai Trial Site 1

Koblenz, Germany

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Eisai Trial Site 1

Lahr, Germany

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Eisai Trial Site 1

Landshut, Germany

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Eisai Trial Site 1

Lemgo, Germany

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Eisai Trial Site 1

Lübeck, Germany

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Eisai Trial Site 1

Magdeburg, Germany

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Eisai Trial Site 1

Mainz, Germany

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Eisai Trial Site 1

Mannheim, Germany

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Eisai Trial Site 1

Marktredwitz, Germany

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Eisai Trial Site 1

München, Germany

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Eisai Trial Site 2

München, Germany

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Eisai Trial Site 3

München, Germany

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Eisai Trial Site 1

Münster, Germany

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Eisai Trial Site 1

Naunhof, Germany

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Eisai Trial Site 1

Nuremberg, Germany

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Eisai Trial Site 1

Oberhausen, Germany

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Eisai Trial Site 1

Offenbach, Germany

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Eisai Trial Site 1

Offenburg, Germany

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Eisai Trial Site 1

Oldenburg, Germany

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Eisai Trial Site 1

Potsdam, Germany

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Eisai Trial Site 1

Püttlingen, Germany

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Eisai Trial Site 1

Quedlinburg, Germany

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Eisai Trial Site 1

Rodgau, Germany

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Eisai Trial Site 1

Rotenburg (Wümme), Germany

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Eisai Trial Site 1

Saarlouis, Germany

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Eisai Trial Site 1

Stolberg, Germany

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Eisai Trial Site 1

Stuttgart, Germany

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Eisai Trial Site 2

Stuttgart, Germany

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Eisai Trial Site 1

Tübingen, Germany

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Eisai Trial Site 1

Villingen-Schwenningen, Germany

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Eisai Trial Site 1

Worms, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms; Peripheral Nervous System Diseases

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 23, 2017
• Study Start: October 13, 2016
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (65)