Metastatic Breast Cancer in Austria

February 28, 2024 updated by: Arbeitsgemeinschaft medikamentoese Tumortherapie

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

3000

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

  • Name: Richard Greil, MD
  • Phone Number: 25801 +43 57255
  • Email: r.greil@salk.at

Study Locations

  • Austria
      • Braunau am Inn, Austria, 5280
        • Recruiting
        • Krankenhaus St. Josef Braunau; Inneren Medizin 2
        • Contact:
          • Florian Roitner, MD
      • Dornbirn, Austria, 6850
        • Recruiting
        • Krankenhaus der Stadt Dornbirn; Brustgesundheitszentrum Dornbirn
        • Contact:
          • Christopher Hager, MD
      • Leoben, Austria, 8700
        • Recruiting
        • Steiermärkische Krankenanstalten- gesellschaft m.b.H. LKH Hochsteiermark; Department für Hämato-Onkologie
        • Contact:
          • Christoph Tinchon, MD
      • Salzburg, Austria, 5020
        • Recruiting
        • Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität; Universitätsklinik für Innere Medizin III Salzburg
        • Contact:
          • Richard Greil, MD
      • St. Pölten, Austria, 3100
        • Recruiting
        • Universitätsklinikum St. Pölten; Abteilung für Innere Medizin 1
        • Contact:
          • Petra Pichler, MD
      • Vienna, Austria, 1160
        • Recruiting
        • Klinik Ottakring; 1. Med. Abteilung, Zentrum f. Onkologie, Hämatologie und Palliativmedizin
        • Contact:
          • Kathrin Strasser-Weippl, MD
      • Wien, Austria, 1090
        • Recruiting
        • AKH Wien; Universitätsklinik für Frauenheilkunde: Klin. Abt. f. Allg. Gynäkologie und gynäkologische Onkologie
        • Contact:
          • Christian Singer, MD
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
        • Recruiting
        • Kepler Universitätsklinikum; Univ.-Klinik für Hämatologie und Internistische Onkologie
        • Contact:
          • Clemens Schmitt, MD
      • Linz, Oberösterreich, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz GmbH - Barmherzige Schwestern; Interne I: Medizinische Onkologie und Hämatologie
        • Contact:
          • Andreas Petzer, MD
      • Steyr, Oberösterreich, Austria, 4400
        • Recruiting
        • Pyhrn-Eisenwurzen Klinikum Steyr; Innere Medizin II: Onkologie, Gastroenterologie, Angiologie
        • Contact:
          • Johannes Andel, MD
      • Wels, Oberösterreich, Austria, 4600
        • Recruiting
        • Klinikum Wels-Grieskirchen GmbH; Abteilung für Innere Medizin IV
        • Contact:
          • Josef Thaler, MD
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Recruiting
        • Steiermärkische Krankenanstalten- gesellschaft m. b. H. LKH-Univ. Klinikum Graz; Universitätsklinik für Innere Medizin; Klinische Abteilung für Onkologie
        • Contact:
          • Marija Balic, MD
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Recruiting
        • Landeskrankenhaus - Universitätskliniken Innsbruck; Universitätsklinik für Frauenheilkunde Innsbruck
        • Contact:
          • Daniel Egle, MD
      • Kufstein, Tirol, Austria, 6330
        • Recruiting
        • BKH Kufstein; Innere Medizin: Interne II und onk. Tagesklinik
        • Contact:
          • August Zabernigg, MD
    • Vorarlberg
      • Feldkirch, Vorarlberg, Austria, 6800
        • Recruiting
        • LKH Feldkirch; Innere Medizin II/ Interne E (Hämatologie und Onkologie)
        • Contact:
          • Bernd Hartmann, MD

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

This registry is a prospective and retrospective, multicentre collection of data on patients with metastatic breast cancer in Austria.

Description

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 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

  • Observational Models: Other
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborators

Eli Lilly and Company
Novartis
Pfizer
Hoffmann-La Roche
AstraZeneca
Seagen Inc.
Caris Life Science
Daiichi Sankyo

Investigators

  • Principal Investigator: Richard Greil, MD, IIIrd Medical Department, Private Medical University Hospital Salzburg

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)

June 15, 2015

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

January 8, 2019

First Submitted That Met QC Criteria

March 8, 2019

First Posted (Actual)

March 12, 2019

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGMT_MBC-Registry

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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