An Observational Study of Cardiac Events in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin® (OHERA)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational post-authorization safety study (PASS)

Study drug and medical condition

• Name of medicine:
  Herceptin
• Medical condition to be studied:
  HER2 positive breast cancer

Population studied

• Short description of the study population:
  Patients with HER2-positive early breast cancer treated with trastuzumab (Herceptin®) in daily clinical practice.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  HER-2 positive breast cancer patients
• Estimated number of subjects:
  3800

Study design details

• Main study objective:
  The main objective will be to observe, in the routine clinical practice setting, the incidence of symptomatic congestive heart failure (CHF, New York Heart Association NYHA class II to IV) and cardiac death of participants diagnosed with HER2-positive early breast cancer who receive Herceptin® as per the approved Summary of Product Characteristics (SmPC).
• Outcomes:
  - Incidence of NYHA class II, III, and IV symptomatic CHF- Incidence of cardiac death, - Association between demographic characteristics and incidence of symptomatic CHF and cardiac death - Time to onset of symptomatic CHF and other significant cardiac conditions - Time to recovery of symptomatic CHF and other significant cardiac conditions - Incidence of asymptomatic left ventricular dysfunction
• Data analysis plan:
  This is an observational study designed to observe the incidence of symptomatic CHF and other significant cardiac events in participants treated with Herceptin for early breast cancer. There is no predefined hypothesis testing. All analyses will be regarded as exploratory and performed annually, available interim data will be reported.Analysis for Primary Objective: The incidence of CHF and of cardiac deaths will be summarized for all participants treated with Herceptin, with 95% Pearson Clopper confidence interval (CI) calculated for the individual rates. The onset of CHF in relation to Herceptin administration will be displayed.Analysis for Secondary Objective: If data permit, characteristics like age, history of disease, and other known risk factors will be evaluated for their prognostic influence on the occurrence of CHF and cardiac death. Time to onset of CHF will be described and estimated using Kaplan-Meier procedures. Duration and time to recovery will be also described.