An observational study in Advanced Breast Cancer and Metastatic Breast Cancer, sponsored by Academisch Ziekenhuis Maastricht. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Academisch Ziekenhuis Maastricht · Observational
The Southeast Netherlands Advanced Breast Cancer (SONABRE) Registry is a real life multi-center study. The registry aims to include all patients diagnosed with advanced breast cancer as of 2007 in 11 hospitals in the Netherlands. Data on patient, tumor and treatment characteristics are collected retrospectively from electronic medical files by trained registry clerks.
This SONABRE registry is an ongoing observational cohort study aiming at the inclusion of all patients aged ≥18 years and diagnosed with advanced breast cancer since 2007 in 11 hospitals in the Southeast of the Netherlands. Patients with de novo or recurrent advanced breast cancer were identified from the hospital-based management information systems. Specially trained registration clerks retrospectively collected data from the medical files of the patients based on extensive medical chart review. Information was collected about patient and tumour characteristics, type of treatment (surgery, radiotherapy and systemic treatment, both neo-adjuvant, adjuvant and palliative), palliative treatment changes due to adverse events, hospitalization, comorbidities and outcomes (progression and death). The SONABRE Registry has already been effectively used to perform real-life studies on the use, safety and (cost-)effectiveness of various systemic treatments used in patients diagnosed with advanced breast cancer.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 7,000 is above the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Academisch Ziekenhuis Maastricht is the lead sponsor of 23 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive patient diagnosed with advanced breast cancer since 2007 in 11 hospitals in the Netherlands. No patients are being excluded. Also patients with no systemic / active anti-tumour therapy for advanced breast cancer will be included. The SONABRE Registry includes 11 hospitals: 1 academic, 7 teaching and 3 general hospitals. The Netherlands counts 114 hospitals, including 8 academic, 25 teaching, 58 general and 23 categorical hospitals.
Inclusion Criteria:
Exclusion Criteria: none
Treatment pattern
Treatment pattern per palliative treatment line; proportion of patients receiving chemotherapy, chemotherapy plus targeted therapy, endocrine therapy, endocrine therapy plus targeted therapy or targeted therapy alone
Time frame: up to 13 years
OS
Overall survival
Time frame: up to 13 years
PFS
Progression-free survival per systemic agent or palliative treatment line
Time frame: up to 13 years
ICER
Incremental cost-effectiveness ratio per QALY (quality-adjusted life year) gained of a new systemic drug compared with standard care
Time frame: up to 13 years
QoL
Quality of life; health state utility score calculated from the EQ-5D questionnaire
Time frame: upt to 13 years
Costs
Costs of advanced breast cancer care from a hospital perspective
Time frame: up to 13 years
Plan to share: No
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Academisch Ziekenhuis Maastricht