Advanced Breast Cancer, Metastatic Breast Cancer
Conditions
Keywords
Breast neoplasms, Neoplasm Metastasis, Registry
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Novartis
Pfizer
Roche Pharma AG
Eli Lilly and Company
ZonMw: The Netherlands Organisation for Health Research and Development
Eisai Inc.
Daiichi Sankyo
AstraZeneca
Gilead Sciences
Academisch Ziekenhuis Maastricht
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with de novo or recurrent advanced breast cancer since 2007 * Diagnosed with or treated for advanced breast cancer in one of the participating hospitals * Participating hospitals (period of inclusion): Maastricht UMC+ (2007-2025), Zuyderland hospitals Sittard/Heerlen (2007-2025), Amphia Hospital Breda (2013-2025), Catharina Hospital Eindhoven (2007-2025), Elkerliek Hospital Helmond (2010-2025), Maxima Medical Center Veldhoven/Eindhoven (2007-2025), Jeroen Bosch Hospital Den Bosch (2013-2025), Laurentius Hospital Roermond (2007-2025), St. Annaziekenhuis Geldrop (2007-2025), St. Elisabeth Hospital Tilburg (2007-2009), St. Jans Gasthuis Weert (2007-2025), VieCuri Medical Center Venlo/Venray (2013-2025), all in the Netherlands. * Hospitals (and periods) were eligible for inclusion if (distant) registration from Maastricht UMC+ was possible. * The inclusion period may be prolonged after 2025.
Exclusion criteria
none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment pattern | up to 13 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | up to 13 years | Overall survival |
| PFS | up to 13 years | Progression-free survival per systemic agent or palliative treatment line |
| ICER | up to 13 years | Incremental cost-effectiveness ratio per QALY (quality-adjusted life year) gained of a new systemic drug compared with standard care |
| QoL | upt to 13 years | Quality of life; health state utility score calculated from the EQ-5D questionnaire |
| Costs | up to 13 years | Costs of advanced breast cancer care from a hospital perspective |
Countries
Netherlands
Contacts
Primary ContactVivianne CG Tjan-Heijnen, MD, PhD
Backup ContactSandra ME Geurts, PhD
Outcome results
None listed