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

Study identification

• EU PAS number:
  EUPAS1000000428
• Study ID:
  1000000428
• Official title and acronym:
  Real-world data of treatment patterns, outcomes and genomic profiling in early breast cancer in Greece (SONATA study)
• DARWIN EU® study:
  No
• Study countries:
  Greece
• Study description:
  SONATA is a research collaboration between the Oncology Department at Iatriko Diavalkaniko Thessalonikis Hospital in Greece and Novartis, focusing on early breast cancer (eBC) patients.; ; Research Collaboration Details: The collaboration is represented by Iatriko Athinon (Iatriko Diavalkaniko Thessalonikis Hospital) and Dr. Konstantinos Papazisis (Primary Investigator) and involves Novartis Hellas contributing scientifically to the research.; ; Study Overview: The study, titled "Real-world data of treatment patterns, Outcomes and genomic profiling in early breast cancer in Greece" (SONATA study), aims to describe patient demographics, clinical characteristics, and treatment patterns in early breast cancer (eBC) in Greece.; ; 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.; ; Study Objectives: The primary objective is to describe patient demographics and clinical characteristics, while the exploratory objective is to test the hypothesis that endocrine resistance molecular subtypes predict early recurrence in HR+/HER2- eBC patients.; ; Statistical Analysis: 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).; ; Pharmacovigilance Requirements: The collaboration partner, as the regulatory sponsor, is responsible for meeting safety reporting requirements to Novartis and health authorities.
• Study status:
  Ongoing

Research institutions and networks

Institutions

European Interbalkan Medical Center (EIMC)

Greece

Study timelines

Date when funding contract was signed

Planned:24/09/2024

Actual:10/10/2024

Study start date

Actual:16/10/2024

Data analysis start date

Planned:21/10/2024

Date of interim report, if expected

Planned:21/10/2025

Date of final study report

Planned:30/09/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Hellas SACI, Research Collaboration in Breast Cancer

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable