An observational safety study to describe the diarrhoea related discontinuations of extended adjuvant neratinib in HER2+ early breast cancer.
An observational safety study to describe the diarrhoea related discontinuations of extended adjuvant neratinib in HER2+ early breast cancer.
Multicentre, multi-country, prospective, observational, post-authorisation safety study to describe the incidence of discontinuation due to diarrhoea within the first 3 months of treatment with neratinib, in adult breast cancer patients treated in extended adjuvant in a real-world setting: the NERLYFE study..
How is the study conducted?
The schema summarizes the study visits:
The core phase covers the first 3 months of neratinib treatment whereas the extended phase lasts up to 24 months of neratinib treatment.
No specific medical procedures or in-person clinical visits beyond routine care will be required for this study.
Who can take part in the trial ?
To be eligible for the study, participant must fulfill several conditions including the following:
• Adult patient assigned to receive extended adjuvant neratinib as indicated in the summary of product characteristics (SmPC).
• Adult patient having received the educational materials (EM).
• Adult patient having provided consent.
What are the objectives of the trial and how are they evaluated ?
The primary objective of the study is to describe the incidence of permanent discontinuation due to diarrhoea in the first 3 months of neratinib treatment.
The key secondary objectives of the study are:
• Description of diarrhoea patterns (e.g. severity, duration, …).
• Assessment of educational material effectiveness (accessibility, knowledge and adherence).
• Impact of treatment-related diarrhoea on quality of life assessed by a questionnaire.
More information
This study is conduect in Austria, Czech Republic, GermanyUnited Kingdom but also extended to additional European countries depending on the reimbursement status in those countries.