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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48088
• EU PAS number:
  EUPAS41584
• Study ID:
  48088
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Czechia

  Germany

  United Kingdom
• Study description:
  The 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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Covance

Clinical Development

Study timelines

Date when funding contract was signed

Planned: 17/12/2020

Study start date

Planned: 16/05/2022

Actual: 09/05/2022

Date of final study report

Planned: 30/06/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pierre Fabre Médicament

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)