An observational safety study to describe the diarrhoea related discontinuations of extended adjuvant neratinib in HER2+ early breast cancer.

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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..

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Brief summary

HER2+ breast cancer is a subtype of breast cancer which represents approximately 15% to 25% of breast cancer worldwide. In patients with early-stage HER2+ breast cancer, a pivotal clinical study demonstrated that the use of neratinib (Nerlynx®), following (neo)adjuvant trastuzumab based therapy improves clinical outcomes of patients. However, neratinib is known to induce diarrhoea, its’ primary side effect. As a consequence, pharmacovigilance activity is performed to better characterise and minimise the risks of diarrhoea associated with the neratinib administration.

In this context, the purpose of this observational, prospective study is to describe the diarrhoea related discontinuations during the use of extended adjuvant neratinib in the real-world setting.

Therapeutic area :
Disease :
Breast cancer
Study medication :
Neratinib (NERLYNX®)
Phase : RWE
Start Date :
09 May 2022
End Date / Planned study Completion Date :
January 2026
Study ID : NIS12501 Number : EUPAS41584
Countries :
Czech Republic
United Kingdom

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