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 type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L01EH02) neratinib

  neratinib
• Medical condition to be studied:
  Diarrhoea
• Additional medical condition(s):
  Early Breast Cancer

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  368

Study design details

• Main study objective:
  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.
• Outcomes:
  Incidence of permanent discontinuation due to diarrhoea within the first 3 months of treatment with neratinib in the approved indication in Europe. Description of diarrhoea patterns. Assessment of educational material effectiveness (accessibility, knowledge and adherence). Impact of treatment-related diarrhoea on quality of life as assessed by the Systemic therapy-induced diarrhoea assessment tool (STIDAT) questionnaire
• Data analysis plan:
  Analysis will be inherently descriptive and information will be reported in summary tables. Summary data will be provided for all variables collected and the data will be reported overall and by country (if relevant). Continuous variables will be summarized using descriptive statistics. The 95% two-sided Confidence Interval (CIs) of means will be calculated when appropriate using the standard method (Standard normal distribution). Categorical variables will be summarized by numbers and proportions. The 95% two-sided CIs of proportions will be calculated when appropriate using the Wald method. Missing data will not be imputed. Time-to-event endpoints will be expressed in months. For the description, Kaplan-Meier estimates (product-limit estimates) will be presented with a summary of associated statistics including the corresponding two-sided 95% confidence intervals. The Kaplan-Meier curve will also be presented. Individual patient listings will also be provided.