G62.0
Conditions
Interventions
Group 1: This is a non-interventional study to determine incidence and time
to resolution of eribulin-induced PN in patients with locally advanced or metastatic
breast cancer when Eribulin is used as
Sponsors
Eisai GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Locally advanced or metastatic breast cancer 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 patients were not suitable for these treatments. (Update Protocol V1.1 13Jun17) - 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 patient to start treatment with eribulin has been made prior to inclusion in this study. - Signed written Informed Consent.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - The number and proportion of patients experiencing eribulin-induced PN (peripheral Neuropathy). - Severity of eribulin-induced PN as determined by CTCAE grade version 4.0. - Frequency of dose modifications or discontinuation of eribulin treatment due to eribulin-induced PN. - Time to eribulin treatment discontinuation due to eribulin-induced PN. - Frequency of resolution of eribulin-induced PN defined as the number and proportion of resolved cases (defined as ended or returned to baseline as determined by CTCAE grade version 4.0) amongst the patients who experience eribulin-induced PN. - Time to resolution of eribulin-induced PN will be 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. - Therapeutic interventions (e.g. analgesics) being used to treat eribulin-induced PN. - Start Aug2016 until approx. Apr 2022 (Prot. v. 2.0, 05.02.2021) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Health-related quality of life scores measured using the PNQ and EQ-5D-3L questionnaires. - Time to disease progression is defined as the time from the start of eribulin treatment to Investigator assessment of disease progression (clinical or radiological). - The number and proportion of patients experiencing non-serious and serious AEs. - The PNQ- und EQ-5D-3L questionnaires will be completed on Day 1 of each treatment cycle. During follow-up phase the PNQ will be filled out every month. | — |
Countries
Germany
Contacts
Public ContactHans-Joachim Lück
Gynäkologisch-Onkologische Praxis am Pelikanplatz
Outcome results
None listed