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

How is the study conducted?

The study was an ancillary study to the Nerlyfe observational, PASS, real-world study. A PASS study is a study that is done after a drug has been authorised. The aim is to obtain further information on the safety of a drug. 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 had decided to treat them with neratinib. The ancillary study total duration was 2 years, including the one year Nerlyfe PASS study.

The main objective of the study was to collect information on the breast cancer recurrence with neratinib treatment during 2 years.

Who can take part in the trial ?

The study took place in Europe. All people who participated in the Nerlyfe PASS study could participate in the ancillary study.

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

* Educational material contained instruction on how to prevent and manage diarrhea if it occurs

What are the objectives of the trial and how are they evaluated ?

The primary objective are to describe the cancer recurrence in people with breast cancer treated by neratinib during 2 years:

To characterise the tumor (localisation and size of tumor, and the time of onset)
To describe the incidence by each type of tumor

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.