An observational study to describe the population of patients treated with extended adjuvant neratinib.
An observational study to describe the population of patients treated with extended adjuvant neratinib.
Retrospective observational study of adult patients with early-stage HER-2 positive breast cancer, treated with neratinib as extended adjuvant therapy in the context of the European Early Access Program - NEAR.
How is the study conducted?
The schema depicted below summarizes the study flow:
Who can take part in the trial ?
To be eligible for the study, participant must fulfill several conditions including the following:
• Patient aged over 18 years at neratinib treatment initiation.
• Patient having received at least one dose of extended adjuvant neratinib in the European EAP between August 01, 2017 and December 31, 2020.
• Patient (or next of kin/legal representative, if applicable) who provides written informed consent or non-opposition.
What are the objectives of the trial and how are they evaluated ?
The primary objective of the study is to describe demographic and clinical characteristics of patients with HER2+ breast cancer treated with neratinib by collecting information such as age, gender, history of disease, ...
The secondary objectives of NEAR are:
• To describe neratinib treatment patterns (e.g. dose, treatment duration, discontinuation ...).
• To describe breast cancer treatment history before neratinib initiation.
• To describe the side effects in patients with breast cancer using neratinib.