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. 

This ancillary study is attached to the following main study: Nerlyfe post-authorisation safety study (PASS). 

This means that people participated firstly in the Nerlyfe PASS study during one year, and then could entere in this ancillary study for one additional year. The aim of the main Nerlyfe study was mainly to see how many people had diarrhoea leading to neratinib discontinuation within the first 3 months. 

The aim of the ancillary study was to describe cancer recurrence in people with breast cancer treated with neratinib for 2 years.