Southeast Netherlands Advanced Metastatic Breast Cancer Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcademisch Ziekenhuis Maastricht
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Treatment pattern
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
Time frame
up to 13 yearsSecondary outcomes
1
OS
Overall survival
Time frame
up to 13 years2
PFS
Progression-free survival per systemic agent or palliative treatment line
Time frame
up to 13 years3
ICER
Incremental cost-effectiveness ratio per QALY (quality-adjusted life year) gained of a new systemic drug compared with standard care
Time frame
up to 13 years4
QoL
Quality of life; health state utility score calculated from the EQ-5D questionnaire
Time frame
upt to 13 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Academisch Ziekenhuis Maastricht
Lead sponsor
Novartis
Collaborator
Pfizer
Collaborator
Roche Pharma AG
Collaborator
Eli Lilly and Company
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Eisai Inc.
Collaborator
Daiichi Sankyo
Collaborator
AstraZeneca
Collaborator
Gilead Sciences
Collaborator
Source ClinicalTrials.gov