Incidence and Resolution of Eribulin-induced peripheral Neuropathy (IRENE)
- Conditions
- G62.0Drug-induced polyneuropathy
- Registration Number
- DRKS00010928
- Lead Sponsor
- Eisai GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 341
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.
- 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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method