Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-05 @ 12:49 AM
Study NCT ID:
NCT03870620
Status:
RECRUITING
Last Update Posted:
2025-04-10
First Post:
2019-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metastatic Breast Cancer in Austria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2019-01-08', 'studyFirstSubmitQcDate': '2019-03-08', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Breast Carcinoma', 'Breast Tumor']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.', 'detailedDescription': '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.\n\nAlso, 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.\n\nThe 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This registry is a prospective and retrospective, multicentre collection of data on patients with metastatic breast cancer in Austria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological evidence of breast cancer\n* Histological and/or radiological evidence of metastases\n* Metastasis within 10 years of registry initiation\n* Signed informed consent (if a patient has already died at the time of entry, the entry can be made without a declaration of consent)\n\nExclusion Criteria:\n\n* Due to the non-interventional design of the registry there are no specific exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT03870620', 'briefTitle': 'Metastatic Breast Cancer in Austria', 'organization': {'class': 'OTHER', 'fullName': 'Arbeitsgemeinschaft medikamentoese Tumortherapie'}, 'officialTitle': 'Metastatic Breast Cancer in Austria', 'orgStudyIdInfo': {'id': 'AGMT_MBC-Registry'}}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'state': 'Salzburg', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Simon Gampenrieder, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität; Universitätsklinik für Innere Medizin III Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Gabriel Rinnerthaler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Steiermärkische Krankenanstalten- gesellschaft m. b. H. LKH-Univ. Klinikum Graz; Universitätsklinik für Innere Medizin; Klinische Abteilung für Onkologie', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Daniel Egle, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Landeskrankenhaus - Universitätskliniken Innsbruck; Universitätsklinik für Frauenheilkunde Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '6330', 'city': 'Kufstein', 'state': 'Tyrol', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'August Zabernigg, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'BKH Kufstein; Innere Medizin: Interne II und onk. Tagesklinik', 'geoPoint': {'lat': 47.58333, 'lon': 12.16667}}, {'zip': '4020', 'city': 'Linz', 'state': 'Upper Austria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Clemens Schmitt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kepler Universitätsklinikum; Univ.-Klinik für Hämatologie und Internistische Onkologie', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '4020', 'city': 'Linz', 'state': 'Upper Austria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Renate Pusch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ordensklinikum Linz GmbH - Barmherzige Schwestern; Interne I: Medizinische Onkologie und Hämatologie', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '4400', 'city': 'Steyr', 'state': 'Upper Austria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Johannes Andel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pyhrn-Eisenwurzen Klinikum Steyr; Innere Medizin II: Onkologie, Gastroenterologie, Angiologie', 'geoPoint': {'lat': 48.04274, 'lon': 14.42127}}, {'zip': '4600', 'city': 'Wels', 'state': 'Upper Austria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Sonja Heibl, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinikum Wels-Grieskirchen GmbH; Abteilung für Innere Medizin IV', 'geoPoint': {'lat': 48.16667, 'lon': 14.03333}}, {'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christian Singer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AKH Wien; Universitätsklinik für Frauenheilkunde: Klin. Abt. f. Allg. Gynäkologie und gynäkologische Onkologie', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '6800', 'city': 'Feldkirch', 'state': 'Vorarlberg', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Bernd Hartmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'LKH Feldkirch; Innere Medizin II/ Interne E (Hämatologie und Onkologie)', 'geoPoint': {'lat': 47.23306, 'lon': 9.6}}, {'zip': '5280', 'city': 'Braunau am Inn', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Florian Roitner, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Krankenhaus St. Josef Braunau; Inneren Medizin 2', 'geoPoint': {'lat': 48.25628, 'lon': 13.04343}}, {'zip': '6850', 'city': 'Dornbirn', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christopher Hager, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Krankenhaus der Stadt Dornbirn; Brustgesundheitszentrum Dornbirn', 'geoPoint': {'lat': 47.41427, 'lon': 9.74195}}, {'zip': '8700', 'city': 'Leoben', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Angelika Pichler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Steiermärkische Krankenanstalten- gesellschaft m.b.H. LKH Hochsteiermark; Department für Hämato-Onkologie', 'geoPoint': {'lat': 47.3765, 'lon': 15.09144}}, {'zip': '3100', 'city': 'Sankt Pölten', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Petra Pichler-Izmir, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum St. Pölten; Abteilung für Innere Medizin 1', 'geoPoint': {'lat': 48.20762, 'lon': 15.63725}}, {'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Rupert Bartsch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UK AKH Wien: Universitätsklinik für Innere Medizin I: Klinische Abteilung für Onkologie', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1160', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Kathrin Strasser-Weippl, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinik Ottakring; 1. Med. Abteilung, Zentrum f. Onkologie, Hämatologie und Palliativmedizin', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Daniela Wolkersdorfer', 'role': 'CONTACT', 'email': 'd.wolkersdorfer@agmt.at', 'phone': '+43 662 6404412'}], 'overallOfficials': [{'name': 'Richard Greil, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'AGMT gemeinnützige GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arbeitsgemeinschaft medikamentoese Tumortherapie', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': 'Novartis', 'class': 'INDUSTRY'}, {'name': 'Caris Life Sciences', 'class': 'INDUSTRY'}, {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, {'name': 'Seagen Inc.', 'class': 'INDUSTRY'}, {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}