Metastatic Breast Cancer in Austria

Recruiting

• Conditions: Breast Carcinoma; Breast Cancer; Breast Tumor

• Registration Number: NCT03870620
• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie

Brief Summary

Breast cancer is the most common cancer among women worldwide. In Austria, this diagnosis is made more than 5000 times a year (STATISTICS AUSTRIA, Austrian Cancer Registry, as of 24.09.2012). Of these, already 5% to 10% have distant metastases at the time of initial diagnosis, and up to 30% of the node-negative tumours and up to 70% of the node-positive tumours metastasise at a later date. Metastatic breast cancer has not been systematically assessed in Austria to date. This medical registry of the AGMT is thus the first Austrian-wide standardised documentation of this disease. The aim of the registry is to answer both epidemiological and therapy-specific questions.

This registry is a prospective and retrospective, multicentre collection of data on patients with metastatic breast cancer in Austria. All tumour characteristics, medical histories and also treatment sequences are documented in anonymised form.

Detailed Description

The present AGMT registry will provide accurate documentation of initial disease progression and initial tumour characteristics in patients with metastatic breast cancer in Austria. The data collected will include: median age at metastasis, median disease-free survival (DFS) between initial diagnosis or first date of absence of disease and occurrence of metastasis, histological subtype of the primary tumour, initial TNM stage, grade and receptor status of the primary tumour, type and form of adjuvant therapy, pattern of metastasis and metastasis site. Characteristics that have a negative prognostic value are expected to be overrepresented in the metastatic patient group.

Also, this AGMT registry is intended to assess the distribution pattern of these metastatic stage subtypes in Austria. Additionally, their influence on treatment strategy and outcome is to be studied. Furthermore, the frequency and tumour characteristics of breast cancer in male patients will be assessed and the influence of gender on treatment strategies identified.

The AGMT breast cancer registry will conduct an exact analysis of survival data, thereby enabling accurate calculations of average survival duration in patients with metastatic breast cancer in Austria. Further parameters that reflect the quality or course of oncological treatment are the survival rates from the time of metastasis development at 1, 2 and 5 years after diagnosis.

This AGMT registry is intended to investigate the response to various therapies in a real life population in relation to previous treatments, concomitant diseases and breast cancer subtype. The aim is to assess which therapies are used at which time point and on which disease subtype they depend.

Study Timeline

• Study Start: 2015-06-15
• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Histological evidence of breast cancer
• Histological and/or radiological evidence of metastases
• Metastasis within 10 years of registry initiation
• Signed informed consent (if a patient has already died at the time of entry, the entry can be made without a declaration of consent)

Exclusion Criteria

• Due to the non-interventional design of the registry there are no specific exclusion criteria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival of patients with metastatic breast cancer in Austria	10 years
Number of patients with prognostic factors for metastatic breast cancer	10 years
Number of patients according to molecular subtypes	10 years
Frequency and tumour characteristics of breast cancer in male patients	10 years

Trial Locations

Locations (16)

UK AKH Wien: Universitätsklinik für Innere Medizin I: Klinische Abteilung für Onkologie; 🇦🇹 Wien, Austria

Kepler Universitätsklinikum; Univ.-Klinik für Hämatologie und Internistische Onkologie; 🇦🇹 Linz, Oberösterreich, Austria

Ordensklinikum Linz GmbH - Barmherzige Schwestern; Interne I: Medizinische Onkologie und Hämatologie; 🇦🇹 Linz, Oberösterreich, Austria

Pyhrn-Eisenwurzen Klinikum Steyr; Innere Medizin II: Onkologie, Gastroenterologie, Angiologie; 🇦🇹 Steyr, Oberösterreich, Austria

Klinikum Wels-Grieskirchen GmbH; Abteilung für Innere Medizin IV; 🇦🇹 Wels, Oberösterreich, Austria

Steiermärkische Krankenanstalten- gesellschaft m. b. H. LKH-Univ. Klinikum Graz; Universitätsklinik für Innere Medizin; Klinische Abteilung für Onkologie; 🇦🇹 Graz, Steiermark, Austria

Landeskrankenhaus - Universitätskliniken Innsbruck; Universitätsklinik für Frauenheilkunde Innsbruck; 🇦🇹 Innsbruck, Tirol, Austria

BKH Kufstein; Innere Medizin: Interne II und onk. Tagesklinik; 🇦🇹 Kufstein, Tirol, Austria

LKH Feldkirch; Innere Medizin II/ Interne E (Hämatologie und Onkologie); 🇦🇹 Feldkirch, Vorarlberg, Austria

Krankenhaus St. Josef Braunau; Inneren Medizin 2; 🇦🇹 Braunau am Inn, Austria

Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität; Universitätsklinik für Innere Medizin III Salzburg; 🇦🇹 Salzburg, Austria

Universitätsklinikum St. Pölten; Abteilung für Innere Medizin 1; 🇦🇹 St. Pölten, Austria

Klinik Ottakring; 1. Med. Abteilung, Zentrum f. Onkologie, Hämatologie und Palliativmedizin; 🇦🇹 Vienna, Austria

AKH Wien; Universitätsklinik für Frauenheilkunde: Klin. Abt. f. Allg. Gynäkologie und gynäkologische Onkologie; 🇦🇹 Wien, Austria

Krankenhaus der Stadt Dornbirn; Brustgesundheitszentrum Dornbirn; 🇦🇹 Dornbirn, Austria

Steiermärkische Krankenanstalten- gesellschaft m.b.H. LKH Hochsteiermark; Department für Hämato-Onkologie; 🇦🇹 Leoben, Austria