Status: Planned First registered on: 15/06/2021
Last updated on: 18/06/2021
1. Study identification
EU PAS Register NumberEUPAS41584
Official titleMulticentre, 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
Study title acronymNERLYFE
Study typeObservational study
Brief description of the studyThe study is a European multi-country, multicentre, prospective, observational, PASS with the primary objective of monitoring the incidence of permanent discontinuations due to diarrhea in the first 3 months of treatment with neratinib in the approved indication. It will be conducted as follows: -Core phase: covering the first 3 months of neratinib treatment and evaluating the incidence of permanent discontinuations due to neratinib-related diarrhoea, diarrhoea patterns and diarrhoea management. The accessibility and understanding of information provided in the Educational Materials (EM), adherence to recommendations described in the EM and impact of the EM on diarrhoea patterns will also be assessed. -Extended phase: continuing patient monitoring until neratinib treatment completion up to 12 months and evaluating the cumulative incidence of permanent discontinuations due to neratinib-related diarrhoea, diarrhoea patterns and diarrhoea management at 6 and 12 months as well as treatment maintenance and impact of treatment-related diarrhoea on quality of life over 12 months. The study will address treating physicians (i.e. investigators) experienced in the administration of anti-cancer medicinal products and prescribing neratinib to their patients, and patients for whom the investigator has decided to begin treatment with neratinib in extended adjuvant in accordance with the approved SmPC and local clinical practice.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameCOVANCE, Clinical Development Sarl
Centre location92500 Rueil-Malmaison, France
Details of (Primary) lead investigator
Title Dr
Last name VALENTI
First name Roberta
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?80
Countries in which this study is being conducted
International study

Austria
Belgium
Czechia
Denmark
Finland
France
Germany
Italy
Spain
Sweden
Switzerland
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed17/12/2020
Start date of data collection25/10/2021
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/2024
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPierre Fabre M├ędicament100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name VALENTI
First name Roberta
Address line 145, place Abel Gance
Address line 2 
Address line 3 
CityBoulogne-Billancourt 
Postcode92100 
CountryFrance
Phone number (incl. country code)33149108481 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name VALENTI 
First name Roberta 
Address line 145, place Abel Gance 
Address line 2 
Address line 3 
CityBoulogne-Billancourt 
Postcode92100 
CountryFrance 
Phone number (incl. country code)33149108481 
Alternative phone number 
Fax number (incl. country code) 
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