A Nerlyfe ancillary study to describe recurrence in breast cancer patients treated with neratinib in a real-world setting
A Nerlyfe ancillary study to describe recurrence in breast cancer patients treated with neratinib in a real-world setting
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..
How is the study conducted?
The study was an observational, PASS, real-world study. A PASS study is a safety study that is done after a drug has been authorized for use. The aim is to obtain further information on the safety of a drug used as approved by the Health Authorities. An observational study looks at how things work in everyday life. Therefore, inclusion and exclusion criteria are less strict compared to clinical interventional trials; as the aim is to reflect the clinical practice of a drug already approved and available in a given indication.
This study was done in people for which the physicians decided to treat them with neratinib. The people should have access to documents with information on neratinib (educational materials). The main objective of the study was to collect information on diarrhoea in the first 3 months with neratinib treatment.
This study included:
- A first phase of 3 months of treatment with neratinib
- The second phase up to 12 months of treatment with neratinib.
Who can take part in the trial ?
The study took place in Europe.
The following people could participate in the study:
- Adult people
- With early stage HER2+ overexpressed/amplified breast cancer
- Who received neratinib as per the Summary of Product Characteristics (SmPC)
- Who received educational material
- Who agreed to participate in the study
What are the objectives of the trial and how are they evaluated ?
The key secondary objectives were:
- To characterise diarrhoea patterns
- To describe neratinib treatment maintenance
- To assess the accessibility, understanding, adherence of the educational material
- To describe the impact of the treatment on the quality of life
What is the study Medication ?
People received neratinib prescribed by their physician. As per inclusion criteria neratinib should be used as indicated in the Summaries of product characteristics (SmPC). The SmPC is a document approved by the Health authorities. The SmPC is used as basis of information for healthcare professionals on how to use the medicine safely and effectively. The dose received was the one effectively received during the study.
More information
This study was conducted according to ethical considerations and followed the rules for conducting such study. The study did not start before it was approved. People provided their consent to participate in.