Southeast Netherlands Advanced Metastatic Breast Cancer Registry

Recruiting

• Conditions: Advanced Breast Cancer; Metastatic Breast Cancer

• Registration Number: NCT03577197
• Lead Sponsor: Academisch Ziekenhuis Maastricht

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.

Study Timeline

• Study Start: 2007-01-01
• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-23
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7000

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.

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Exclusion Criteria

none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Costs	up to 13 years	Costs of advanced breast cancer care from a hospital perspective
PFS	up to 13 years	Progression-free survival per systemic agent or palliative treatment line
OS	up to 13 years	Overall survival
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

Trial Locations

Locations (1)

Multiple hospitals in the Netherlands (see Eligibility); 🇳🇱 Maastricht, Netherlands