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Recruiting

Southeast Netherlands Advanced Metastatic Breast Cancer Registry

NCT03577197 · Academisch Ziekenhuis Maastricht
In plain English

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Official title
Southeast Netherlands Advanced Breast Cancer Registry
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 7000 participants
Age groups: adult, older_adult
Timeline
Starts: 2007-01-01
Estimated completion: 2027-12-31
Last updated: 2024-07-23
Primary outcomes
  • Treatment pattern (up to 13 years)
Sponsor
Academisch Ziekenhuis Maastricht · other
With: 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
Contacts & investigators
ContactVivianne CG Tjan-Heijnen, MD, PhD · contact · vcg.tjan.heijnen@mumc.nl · +31 (0) 43 3877025
ContactSandra ME Geurts, PhD · contact · sandra.geurts@mumc.nl · +31 (0) 43 3877025
All locations (1)
Multiple hospitals in the Netherlands (see Eligibility)Recruiting
Maastricht, Netherlands
Southeast Netherlands Advanced Metastatic Breast Cancer Registry · TrialPath