Real-world data of treatment patterns, outcomes and genomic profiling in early breast cancer in Greece (SONATA study)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  This is a non-interventional, observational, single-center, primary data collection study, which will include a representative sample of outpatients diagnosed with early Breast Cancer (eBC) in Northern Greece. The collaborator holds a database of eBC patients (~2000 patients up to date) and of good quality. The collaborator is also performing genomic profile analysis for various mutations as part of his clinical practice. Data will be retrieved from the electronic patient database owned by the collaborator.

Study drug and medical condition

• Medical condition to be studied:
  Breast cancer

Population studied

• Age groups:
  Adult and elderly population (≥18 years)

  Adults (18 to < 65 years)

  Elderly (≥ 65 years)

Study design details

• Study design:
  This non-interventional, observational study will include data analysis of approximately 2000 eBC patients and genomic profile analysis of 300 HR+/HER2- patients using the PRIME-Dx platform.
• Main study objective:
  The study aims to describe patient demographics, clinical characteristics, and treatment patterns in early breast cancer (eBC) in Greece.
• Data analysis plan:
  The study will use descriptive statistics to present continuous and categorical variables, and time-to-event analyses for recurrence-free survival (RFS) and breast cancer-free interval (BCFi).