Metastatic Breast Cancer in Austria

Breast Cancer Clinical Trial

Official title:

Metastatic Breast Cancer in Austria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03870620
• Other study ID #: AGMT_MBC-Registry
• Status: Recruiting
• Start date: June 15, 2015
• Est. completion date: June 2025

Study information

• Verified date: February 2023
• Source: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Contact: Richard Greil, MD
• Phone: +43 57255
• Email: r.greil[@]salk.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Carcinoma
• Breast Neoplasms
• Breast Tumor

Locations

Country	Name	City	State
Austria	Krankenhaus St. Josef Braunau; Inneren Medizin 2	Braunau am Inn
Austria	Krankenhaus der Stadt Dornbirn; Brustgesundheitszentrum Dornbirn	Dornbirn
Austria	LKH Feldkirch; Innere Medizin II/ Interne E (Hämatologie und Onkologie)	Feldkirch	Vorarlberg
Austria	Steiermärkische Krankenanstalten- gesellschaft m. b. H. LKH-Univ. Klinikum Graz; Universitätsklinik für Innere Medizin; Klinische Abteilung für Onkologie	Graz	Steiermark
Austria	Landeskrankenhaus - Universitätskliniken Innsbruck; Universitätsklinik für Frauenheilkunde Innsbruck	Innsbruck	Tirol
Austria	BKH Kufstein; Innere Medizin: Interne II und onk. Tagesklinik	Kufstein	Tirol
Austria	Steiermärkische Krankenanstalten- gesellschaft m.b.H. LKH Hochsteiermark; Department für Hämato-Onkologie	Leoben
Austria	Kepler Universitätsklinikum; Univ.-Klinik für Hämatologie und Internistische Onkologie	Linz	Oberösterreich
Austria	Ordensklinikum Linz GmbH - Barmherzige Schwestern; Interne I: Medizinische Onkologie und Hämatologie	Linz	Oberösterreich
Austria	Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität; Universitätsklinik für Innere Medizin III Salzburg	Salzburg
Austria	Universitätsklinikum St. Pölten; Abteilung für Innere Medizin 1	St. Pölten
Austria	Pyhrn-Eisenwurzen Klinikum Steyr; Innere Medizin II: Onkologie, Gastroenterologie, Angiologie	Steyr	Oberösterreich
Austria	Klinik Ottakring; 1. Med. Abteilung, Zentrum f. Onkologie, Hämatologie und Palliativmedizin	Vienna
Austria	Klinikum Wels-Grieskirchen GmbH; Abteilung für Innere Medizin IV	Wels	Oberösterreich
Austria	AKH Wien; Universitätsklinik für Frauenheilkunde: Klin. Abt. f. Allg. Gynäkologie und gynäkologische Onkologie	Wien

Sponsors (9)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie	AstraZeneca, Caris Life Science, Daiichi Sankyo, Eli Lilly and Company, Hoffmann-La Roche, Novartis, Pfizer, Seagen Inc.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with prognostic factors for metastatic breast cancer		10 years
Primary	Number of patients according to molecular subtypes		10 years
Primary	Frequency and tumour characteristics of breast cancer in male patients		10 years
Primary	Overall survival of patients with metastatic breast cancer in Austria		10 years