GARDENIA: A Multi-country Observational Serial Chart Review Study of KANJINTI use in Europe

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Single-arm, observational, serial chart review

Study drug and medical condition

• Name of medicine:
  KANJINTI
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XC03) trastuzumab

  trastuzumab
• Medical condition to be studied:
  HER2 positive breast cancer

Population studied

• Short description of the study population:
  Adult patients aged 18 years or older with human epidermal growth factor receptor 2 positive (HER2+) breast cancer receiving KANJINTI as treatment to understand the treatment patterns.; Inclusion criteria: ; • Patients who have HER2+ breast cancer in any stage of disease whether metastatic or early ; • Patients receiving or having received KANJINTI treatment according to the judgment of the physician, after adoption of KANJINTI on the institution formulary, in routine clinical practice; • Patients are aged ≥ 18 years at KANJINTI initiation; ; Exclusion criteria:; • Currently participation or planning to participate in a concurrent interventional clinical trial involving therapeutic agent(s); • Have other cancer type(s), concurrent to breast cancer; • Patients that have not provided an informed consent, where required per country-specific regulations; • Patients whose medical chart is not available for data extraction
• 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:
  Breast Cancer patients
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  To describe the characteristics of breast cancer patients receiving KANJINTI
• Outcomes:
  • Describe characteristics of breast cancer patients receiving KANJINTI• Describe if the patient was trastuzumab treatment naïve or if the patient was switched. For patients who received Herceptin, which route was used for administration (IV or SC). • Gather therapies given with KANJINTI• Describe reasons for KANJINTI discontinuation and subsequent treatment plan
• Data analysis plan:
  The approach to the statistical analysis will be generally descriptive. No formal hypotheses will be tested.Categorical data will be summarized by the number and percentage of patients in each category. Two-sided 95% CIs calculated using Wilson’s method where appropriate will be presented. Continuous data will be summarized by mean (and 95% CI where appropriate), SD, median, lower and upper quartiles, and minimum and maximum values. Time-to-event endpoints (time from KANJINTI initiation to the specific events) will be summarized using Kaplan-Meier methodology.Analyses will be presented by treatment setting (neo-adjuvant, adjuvant, and metastatic) and trastuzumab initiation status (naïve new starter, switcher)

Documents

Study results

20180020_ORSR