Clinical trial NCT03577197: Southeast Netherlands Advanced Metastatic Breast Cancer Registry
Official title: Southeast Netherlands Advanced Breast Cancer Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Breast Cancer
Metastatic Breast Cancer
Keywords: Breast neoplasms
Neoplasm Metastasis
Registry
Lead sponsor: Academisch Ziekenhuis Maastricht
Sponsor class: OTHER
Collaborators: name: Novartis
name: Pfizer
name: Roche Pharma AG
name: Eli Lilly and Company
name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Eisai Inc.
name: Daiichi Sankyo
name: AstraZeneca
name: Gilead Sciences
First posted: 2018-07-05
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Treatment pattern
timeFrame: up to 13 years
Secondary outcomes:
measure: OS
timeFrame: up to 13 years
measure: PFS
timeFrame: up to 13 years
measure: ICER
timeFrame: up to 13 years
measure: QoL
timeFrame: upt to 13 years
measure: Costs
timeFrame: up to 13 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Multiple hospitals in the Netherlands (see Eligibility)
Study officials:
References:
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