Safety evaluation of biosimilar trastuzumab in breast cancer: Experience of Colombian institutions

Study type

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

  Safety study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Profile the safety of the biosimilar trastuzumab in Colombia

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective descriptive study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L01FD01) trastuzumab

  trastuzumab
• Medical condition to be studied:
  Breast cancer metastatic
• Additional medical condition(s):
  Adjuvant 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:
  100

Study design details

• Main study objective:
  To describe the frequency of adverse events by degree of severity and anatomical group to detail establish the safety profile of the biosimilar trastuzumab used for breast cancer in Colombian healthcare institutions.
• Outcomes:
  Secondary Objectives: Perform the clinical characterization of patients who were treated with the biosimilar trastuzumab for breast cancer. Exploratory objectives: a)To calculate the overall survival (OS) and progression-free survival (PFS) in patients treated with the biosimilar trastuzumab for breast cancer, b)To explore the factors associated with effectiveness and safety in patients treat
• Data analysis plan:
  Descriptive statistics will be produced for all variables. These will include estimates of the mean, standard deviation, 95% confidence intervals of the mean, median, interquartile ranges and frequency distributions for continuous scale variables and frequency distributions for categorical scale variables. The normality of the continuous variables will be assessed using the Kolmogorov test or the Shapiro Wilk test according to the number of samples collected. Time to event data including time to disease progression, death, partial response and complete response will be described using the Kaplan Meier estimator of the Survival Function. Associated factors of response to treatment will be identified among patient, disease and treatment parameters using Cox Proportional Hazard Models. The main factors that would be assessed in these analyses: Age, Diagnosis date, Stage, ECOG Status, Metastasis, Sites of metastasis, treatment received and AE. Log rank test will be used to compare the d