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Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy (NCT03027245)

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 participants treated with eribulin in a real-life setting for locally advanced or metastatic breast cancer following one or two prior chemotherapeutic regimens for advanced disease.
  • Drug: Eribulin
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Accepts Healthy Volunteers
    Inclusion Criteria:
    • Locally advanced or metastatic breast cancer eligible for treatment with eribulin according to Fachinformation (German equivalent of Summary of Product Characteristics)
    • Maximum of two 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

    31 locations

    Germany (31)
    • recruiting
      Aschaffenburg, Germany
    • recruiting
      Augsburg, Germany
    • recruiting
      Berlin, Germany
    • not yet recruiting
      Bonn, Germany
    • recruiting
      Darmstadt, Germany
    • recruiting
      Donauwörth, Germany
    • not yet recruiting
      Essen, Germany
    • not yet recruiting
      Esslingen, Germany
    • recruiting
      Eutin, Germany
    • recruiting
      Freiburg, Germany
    • recruiting
      Gelsenkirchen, Germany
    • recruiting
      Georgsmarienhutte, Germany
    • not yet recruiting
      Greifswald, Germany
    • recruiting
      Hannover, Germany
    • recruiting
      Hof, Germany
    • recruiting
      Ilsede, Germany
    • not yet recruiting
      Kassel, Germany
    • recruiting
      Kiel, Germany
    • not yet recruiting
      Köln, Germany
    • recruiting
      Landshut, Germany
    • recruiting
      Lemgo, Germany
    • recruiting
      München, Germany
    • not yet recruiting
      Nürnberg, Germany
    • not yet recruiting
      Oberhausen, Germany
    • recruiting
      Offenburg, Germany
    • not yet recruiting
      Potsdam, Germany
    • recruiting
      Rodgau, Germany
    • recruiting
      Rotenburg, Germany
    • recruiting
      Tübingen, Germany
    • recruiting
      Villingen-Schwenningen, Germany
    • not yet recruiting
      Worms, Germany
    31 July, 2016
    18 January, 2017
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