Clinical trial NCT03870620: Metastatic Breast Cancer in Austria
Official title: Metastatic Breast Cancer in Austria
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Breast Carcinoma
Breast Tumor
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
name: Daiichi Sankyo
name: Pfizer
name: Novartis
name: Caris Life Sciences
name: AstraZeneca
name: Seagen Inc.
name: Eli Lilly and Company
First posted: 2019-03-12
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.

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.

Primary outcomes:
measure: Number of patients with prognostic factors for metastatic breast cancer
timeFrame: 10 years
measure: Number of patients according to molecular subtypes
timeFrame: 10 years
measure: Frequency and tumour characteristics of breast cancer in male patients
timeFrame: 10 years
measure: Overall survival of patients with metastatic breast cancer in Austria
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler Universitätsklinikum; Univ.-Klinik für Hämatologie und Internistische Onkologie
state: Oberösterreich
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH - Barmherzige Schwestern; Interne I: Medizinische Onkologie und Hämatologie
state: Oberösterreich
city: Steyr
country: Austria
facility: Pyhrn-Eisenwurzen Klinikum Steyr; Innere Medizin II: Onkologie, Gastroenterologie, Angiologie
state: Oberösterreich
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH; Abteilung für Innere Medizin IV
state: Oberösterreich
city: Graz
country: Austria
facility: Steiermärkische Krankenanstalten- gesellschaft m. b. H. LKH-Univ. Klinikum Graz; Universitätsklinik für Innere Medizin; Klinische Abteilung für Onkologie
state: Steiermark
city: Innsbruck
country: Austria
facility: Landeskrankenhaus - Universitätskliniken Innsbruck; Universitätsklinik für Frauenheilkunde Innsbruck
state: Tirol
city: Kufstein
country: Austria
facility: BKH Kufstein; Innere Medizin: Interne II und onk. Tagesklinik
state: Tirol
city: Feldkirch
country: Austria
facility: LKH Feldkirch; Innere Medizin II/ Interne E (Hämatologie und Onkologie)
state: Vorarlberg
city: Braunau am Inn
country: Austria
facility: Krankenhaus St. Josef Braunau; Inneren Medizin 2
city: Dornbirn
country: Austria
facility: Krankenhaus der Stadt Dornbirn; Brustgesundheitszentrum Dornbirn
city: Leoben
country: Austria
facility: Steiermärkische Krankenanstalten- gesellschaft m.b.H. LKH Hochsteiermark; Department für Hämato-Onkologie
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität; Universitätsklinik für Innere Medizin III Salzburg
city: St. Pölten
country: Austria
facility: Universitätsklinikum St. Pölten; Abteilung für Innere Medizin 1
city: Vienna
country: Austria
facility: Klinik Ottakring; 1. Med. Abteilung, Zentrum f. Onkologie, Hämatologie und Palliativmedizin
city: Wien
country: Austria
facility: AKH Wien; Universitätsklinik für Frauenheilkunde: Klin. Abt. f. Allg. Gynäkologie und gynäkologische Onkologie
city: Wien
country: Austria
facility: UK AKH Wien: Universitätsklinik für Innere Medizin I: Klinische Abteilung für Onkologie
Study officials:
affiliation: AGMT gemeinnützige GmbH
name: Richard Greil, MD
role: STUDY_CHAIR
References: