NCT03870620

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2015

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

10 years

First QC Date

January 8, 2019

Last Update Submit

April 9, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • Overall survival of patients with metastatic breast cancer in Austria

    10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität; Universitätsklinik für Innere Medizin III Salzburg

Salzburg, Salzburg, 5020, Austria

RECRUITING

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

Graz, Styria, 8036, Austria

RECRUITING

Landeskrankenhaus - Universitätskliniken Innsbruck; Universitätsklinik für Frauenheilkunde Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

BKH Kufstein; Innere Medizin: Interne II und onk. Tagesklinik

Kufstein, Tyrol, 6330, Austria

RECRUITING

Kepler Universitätsklinikum; Univ.-Klinik für Hämatologie und Internistische Onkologie

Linz, Upper Austria, 4020, Austria

RECRUITING

Ordensklinikum Linz GmbH - Barmherzige Schwestern; Interne I: Medizinische Onkologie und Hämatologie

Linz, Upper Austria, 4020, Austria

RECRUITING

Pyhrn-Eisenwurzen Klinikum Steyr; Innere Medizin II: Onkologie, Gastroenterologie, Angiologie

Steyr, Upper Austria, 4400, Austria

RECRUITING

Klinikum Wels-Grieskirchen GmbH; Abteilung für Innere Medizin IV

Wels, Upper Austria, 4600, Austria

RECRUITING

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

Vienna, Vienna, 1090, Austria

RECRUITING

LKH Feldkirch; Innere Medizin II/ Interne E (Hämatologie und Onkologie)

Feldkirch, Vorarlberg, 6800, Austria

RECRUITING

Krankenhaus St. Josef Braunau; Inneren Medizin 2

Braunau am Inn, 5280, Austria

RECRUITING

Krankenhaus der Stadt Dornbirn; Brustgesundheitszentrum Dornbirn

Dornbirn, 6850, Austria

RECRUITING

Steiermärkische Krankenanstalten- gesellschaft m.b.H. LKH Hochsteiermark; Department für Hämato-Onkologie

Leoben, 8700, Austria

RECRUITING

Universitätsklinikum St. Pölten; Abteilung für Innere Medizin 1

Sankt Pölten, 3100, Austria

RECRUITING

UK AKH Wien: Universitätsklinik für Innere Medizin I: Klinische Abteilung für Onkologie

Vienna, 1090, Austria

RECRUITING

Klinik Ottakring; 1. Med. Abteilung, Zentrum f. Onkologie, Hämatologie und Palliativmedizin

Vienna, 1160, Austria

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Richard Greil, MD

    AGMT gemeinnützige GmbH

    STUDY CHAIR

Central Study Contacts

Daniela Wolkersdorfer

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2019

First Posted

March 12, 2019

Study Start

June 15, 2015

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

April 10, 2025

Record last verified: 2025-04

Locations