Neratinib in patients with HER2+ breast cancer: a multi-centric, multi-national, prospective, longitudinal, non-interventional study in Switzerland, Germany and Austria. rEal-LifE pAN-HER-blOckade with neRatinib: ELEANOR

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How is the study conducted?

The study was an observational, real-world study.
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.

The aim was to obtain further information on the real-world use of neratinib. This study was done in people treated with neratinib by their physician.
This study included:

One period of 12 months
One period of follow-up after the end of neratinib treatment up to 13 months after the last participant started neratinib treatment.

Who can take part in the trial ?

The study took place in Austria, Germany, and Switzerland.

The following people could participate in the study:

Adult women
With HER2-overexpressing/amplified breast cancer stage I-III
Having completed adjuvant trastuzumab-based therapy less than one year ago
Who received neratinib as extended adjuvant treatment
Who agreed to participate in the study

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

The primary objective was to see if people are taking well neratinib (this is named “adherence”). People were adherent, if for at least 75/100 of people (75%) of the treatment days:

They had taken at least one tablet of neratinib on days it was planned to take it
They had not taken neratinib when it was not planned to take it

The secondary main objectives were to describe:

People and disease characteristics at baseline
Characteristics of prior trastuzumab-based therapy in case of neo-adjuvant pre-treatment was taken
Neratinib-treatment characteristics (duration, dose modification…)
People answer to quality of life questionnaires (EQ-5D* and STIDAT*)
Physician’s and people treatment satisfaction with neratinib
Safety and tolerability of treatment with neratinib

* EQ-5D (Euro Quality of life 5 Dimensions) and STIDAT (Systemic Treatment-Induced Diarrhea Assessment Tool)

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 had to provide their consent to participate in.