Southeast Netherlands Advanced Metastatic Breast Cancer Registry

Официальное название

Southeast Netherlands Advanced Breast Cancer Registry

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Treatment pattern [Срок оценки: up to 13 years]

Вторичные конечные точки (5)

• OS [Срок оценки: up to 13 years]
• PFS [Срок оценки: up to 13 years]
• ICER [Срок оценки: up to 13 years]
• QoL [Срок оценки: upt to 13 years]
• Costs [Срок оценки: up to 13 years]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 1 центр

• Multiple hospitals in the Netherlands (see Eligibility) — Maastricht

Публикации

• Lobbezoo DJ, van Kampen RJ, Voogd AC, Dercksen MW, van den Berkmortel F, Smilde TJ, van de Wouw AJ, Peters FP, van Riel JM, Peters NA, de Boer M, Peer PG, Tjan-Heijnen VC. Prognosis of metastatic breast cancer: are there differences between patients with de novo and recurrent metastatic breast cancer? Br J Cancer. 2015 Apr 28;112(9):1445-51. doi: 10.1038/bjc.2015.127. Epub 2015 Apr 16. PMID 25880008
• Lobbezoo DJ, van Kampen RJ, Voogd AC, Dercksen MW, van den Berkmortel F, Smilde TJ, van de Wouw AJ, Peters FP, van Riel JM, Peters NA, de Boer M, Borm GF, Tjan-Heijnen VC. Prognosis of metastatic breast cancer subtypes: the hormone receptor/HER2-positive subtype is associated with the most favorable outcome. Breast Cancer Res Treat. 2013 Oct;141(3):507-14. doi: 10.1007/s10549-013-2711-y. Epub 2013 PMID 24104881
• Lobbezoo D, Truin W, Voogd A, Roumen R, Vreugdenhil G, Dercksen MW, van den Berkmortel F, Smilde T, van de Wouw A, van Kampen R, van Riel J, Peters N, Peer P, Tjan-Heijnen VC. The role of histological subtype in hormone receptor positive metastatic breast cancer: similar survival but different therapeutic approaches. Oncotarget. 2016 May 17;7(20):29412-9. doi: 10.18632/oncotarget.8838. PMID 27121067
• Lobbezoo DJ, van Kampen RJ, Voogd AC, Dercksen MW, van den Berkmortel F, Smilde TJ, van de Wouw AJ, Peters FP, van Riel JM, Peters NA, de Boer M, Peer PG, Tjan-Heijnen VC. In real life, one-quarter of patients with hormone receptor-positive metastatic breast cancer receive chemotherapy as initial palliative therapy: a study of the Southeast Netherlands Breast Cancer Consortium. Ann Oncol. 2016 Feb PMID 26578730
• van Kampen RJW, Ramaekers BLT, Lobbezoo DJA, de Boer M, Dercksen MW, van den Berkmortel F, Smilde TJ, van de Wouw AJ, Peters FPJ, van Riel JMG, Peters NAJB, Tjan-Heijnen VCG, Joore MA. Real-world and trial-based cost-effectiveness analysis of bevacizumab in HER2-negative metastatic breast cancer patients: a study of the Southeast Netherlands Breast Cancer Consortium. Eur J Cancer. 2017 Jul;79:238- PMID 28245951
• Knapen LM, Geurts SME, Ibragimova KIE, Croes S, Vriens BEPJ, van den Berkmortel FWPJ, Dercksen MW, van de Wouw AJ, Pepels MJAE, de Fallois AOJ, Lobbezoo DJA, de Boer M, Tjan-Heijnen VCG. A real-life study on the implementation and effectiveness of exemestane plus everolimus per hospital type in patients with advanced breast cancer. A study of the Southeast Netherlands Advanced Breast Cancer regist PMID 30641299
• Pouwels XGLV, Geurts SME, Ramaekers BLT, Erdkamp F, Vriens BEPJ, Aaldering KNA, van de Wouw AJ, Dercksen MW, Smilde TJ, Peters NAJB, Riel JMV, Pepels MJ, Heijnen-Mommers J, Joore MA, Tjan-Heijnen VCG, de Boer M. The relative effectiveness of eribulin for advanced breast cancer treatment: a study of the southeast Netherlands advanced breast cancer registry. Acta Oncol. 2020 Jan;59(1):82-89. doi: 10 PMID 31583931
• Schneider PP, Pouwels XGLV, Passos VL, Ramaekers BLT, Geurts SME, Ibragimova KIE, de Boer M, Erdkamp F, Vriens BEPJ, van de Wouw AJ, den Boer MO, Pepels MJ, Tjan-Heijnen VCG, Joore MA. Variability of cost trajectories over the last year of life in patients with advanced breast cancer in the Netherlands. PLoS One. 2020 Apr 9;15(4):e0230909. doi: 10.1371/journal.pone.0230909. eCollection 2020. PMID 32271794

Идентификаторы

NCT: NCT03577197 · MUMC-MO-2015-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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