Metastatic Breast Cancer in Austria
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Breast Carcinoma, Breast Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Number of patients with prognostic factors for metastatic breast cancer [Time frame: 10 years]
- Number of patients according to molecular subtypes [Time frame: 10 years]
- Frequency and tumour characteristics of breast cancer in male patients [Time frame: 10 years]
- Overall survival of patients with metastatic breast cancer in Austria [Time frame: 10 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Austria · 16 centers
- Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatunivers — Salzburg
- AKH Wien; Universitätsklinik für Frauenheilkunde: Klin. Abt. f. Allg. Gynäkologie und gynä — Vienna
- Steiermärkische Krankenanstalten- gesellschaft m. b. H. LKH-Univ. Klinikum Graz; Universit — Graz
- Landeskrankenhaus - Universitätskliniken Innsbruck; Universitätsklinik für Frauenheilkunde — Innsbruck
- BKH Kufstein; Innere Medizin: Interne II und onk. Tagesklinik — Kufstein
- Kepler Universitätsklinikum; Univ.-Klinik für Hämatologie und Internistische Onkologie — Linz
- Ordensklinikum Linz GmbH - Barmherzige Schwestern; Interne I: Medizinische Onkologie und H — Linz
- Pyhrn-Eisenwurzen Klinikum Steyr; Innere Medizin II: Onkologie, Gastroenterologie, Angiolo — Steyr
- … and 8 more centers
Identifiers
NCT: NCT03870620 · AGMT_MBC-Registry