The NERLYFE study
Research type
Research Study
Full title
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
IRAS ID
308136
Contact name
Medy Tsalic
Contact email
Sponsor organisation
Pierre Fabre Médicament
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The purpose of this observational study is 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 a real world setting. The study will also evaluate the accessibility and understanding of information provided in the neratinib educational materials.
Approximately 632 patients will take part in the study at a number of sites in the UK and Europe.
The total duration of participation in the study will be up to 12 months, which corresponds to the planned treatment period with neratinib.
Patients who agree to take part in the main study will be offered to participate in an ancillary study. The purpose of the ancillary study is to monitor the frequency of disease recurrences at 2 years after neratinib treatment initiation. For patients who agree to participate in the ancillary study, participation will be extended for 12 additional months.
The main and ancillary studies will be performed under conditions of routine clinical practice and will not interfere with any aspect of patient clinical management. All patients will be treated and monitored according to local clinical practice. Participants will also be asked to complete a survey assessing the understanding of information provided in the educational material and a questionnaire assessing the impact of treatment-related diarrhoea on quality of life. No additional procedures or visits will apply.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
22/NW/0033
Date of REC Opinion
5 Apr 2022
REC opinion
Further Information Favourable Opinion