Southeast Netherlands Advanced Metastatic Breast Cancer Registry (SONABRE)

July 19, 2024 updated by: V.C.G. Tjan-Heijnen, Academisch Ziekenhuis Maastricht

Southeast Netherlands Advanced Breast Cancer Registry

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

7000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Recruiting
        • Multiple hospitals in the Netherlands (see Eligibility)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment pattern
Time Frame: 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
up to 13 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: up to 13 years
Overall survival
up to 13 years
PFS
Time Frame: up to 13 years
Progression-free survival per systemic agent or palliative treatment line
up to 13 years
ICER
Time Frame: up to 13 years
Incremental cost-effectiveness ratio per QALY (quality-adjusted life year) gained of a new systemic drug compared with standard care
up to 13 years
QoL
Time Frame: upt to 13 years
Quality of life; health state utility score calculated from the EQ-5D questionnaire
upt to 13 years
Costs
Time Frame: up to 13 years
Costs of advanced breast cancer care from a hospital perspective
up to 13 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Ziekenhuis Maastricht

Collaborators

Eli Lilly and Company
Novartis
Pfizer
Gilead Sciences
Roche Pharma AG
AstraZeneca
Eisai Inc.
ZonMw: The Netherlands Organisation for Health Research and Development
Daiichi Sankyo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2007

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 11, 2018

First Submitted That Met QC Criteria

July 2, 2018

First Posted (Actual)

July 5, 2018

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 19, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUMC-MO-2015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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