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NCT Number: NCT03577197

Southeast Netherlands Advanced Metastatic 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.

Recruiting

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Key information

Conditions

Advanced Breast Cancer Breast Diseases Breast Neoplasms Metastatic Breast Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple hospitals in the Netherlands (see Eligibility)

Maastricht, Netherlands

Location status: Recruiting

Location contact

Vivianne CG Tjan-Heijnen, MD, PhD

CONTACT

[email protected]

+31 (0) 43 3877025

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. OS

    Time frame: up to 13 years

    Overall survival

  2. PFS

    Time frame: up to 13 years

    Progression-free survival per systemic agent or palliative treatment line

  3. 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

  4. QoL

    Time frame: upt to 13 years

    Quality of life; health state utility score calculated from the EQ-5D questionnaire

  5. Costs

    Time frame: up to 13 years

    Costs of advanced breast cancer care from a hospital perspective

Study contacts

Contact information is provided by the study sponsor or research team.

Sandra ME Geurts, PhD

CONTACT

[email protected]

+31 (0) 43 3877025

Vivianne CG Tjan-Heijnen, MD, PhD

CONTACT

[email protected]

+31 (0) 43 3877025

Sponsors and collaborators

Lead sponsor

Academisch Ziekenhuis Maastricht

Other

Collaborators

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

Registry information

Official study title

Southeast Netherlands Advanced Breast Cancer Registry

Acronym: SONABRE

Important dates

Study start
2007
Primary completion
2027
Study completion
2027
First posted
Jul 5, 2018
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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