A Nerlyfe ancillary study to describe recurrence in breast cancer patients treated with neratinib in a real-world setting 

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.