Metastatic Breast Cancer in Austria

April 9, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:
          • Angelika PICHLER, MD
      • Salzburg, Austria, 5020
        • Recruiting
        • Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität; Universitätsklinik für Innere Medizin III Salzburg
        • Contact:
          • Simon Gampenrieder, MD
      • St. Pölten, Austria, 3100
        • Recruiting
        • Universitätsklinikum St. Pölten; Abteilung für Innere Medizin 1
        • Contact:
          • Petra Pichler-Izmir, 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
      • Wien, Austria, 1090
        • Recruiting
        • UK AKH Wien: Universitätsklinik für Innere Medizin I: Klinische Abteilung für Onkologie
        • Contact:
          • Rupert Bartsch, 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:
          • Renate Pusch, 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:
          • Sonja HEIBL, 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:
          • Gabriel Rinnerthaler, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eli Lilly and Company
Novartis
Pfizer
Hoffmann-La Roche
AstraZeneca
Seagen Inc.
Caris Life Sciences
Daiichi Sankyo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Richard Greil, MD, AGMT gemeinnützige GmbH

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

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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