An observational study to describe the population of patients treated with extended adjuvant neratinib.

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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.

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How is the study conducted?

The schema depicted below summarizes the study flow:

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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.


Study primary results :

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