Study Results
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Basic Information
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RECRUITING
13500 participants
OBSERVATIONAL
2014-06-30
2030-07-31
Brief Summary
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Recently, novel advances in breast cancer therapy aim at the targeted therapy of tumor entities and identification of patients, for whom the greatest therapy benefit, and the least side effects are expected.
However molecular assessment of the patient and the tumor in the metastatic situation is not performed on a routine basis and in many cases tumor character-istics from the primary tumor are considered reliable enough to make therapy decisions for the metastatic patients. Although molecular reassessment of tu-mor characteristics from tumor material of the metastasis is recommended in national guidelines, only a minority of patients is biopsied, because of the inva-siveness of the procedure, even though biopsy related complications are reported to be rare.
With modern analytic methods from blood based biomaterial there seems to be an opportunity to correlate blood based tumor assessments with actual charac-teristics of the tumor. These include expression analysis, tumor mutation analy-sis, tumor gene copy number aberrations and others. One of the main aims of the PRAEGNANT study is therefore to establish an infrastructure for the compre-hensive analysis of tumor and metastatic molecular characteristics of the patient and the tumor.
Furthermore, health care related outcomes as well as health economics provide novel approaches for integration of patients in study conduct and health care awareness and are study aims of the PRAEGNANT study.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
OTHER
Study Groups
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Advanced/metastatic breast cancer
3,500 patients with locally advanced, inoperable/metastatic breast cancer in any line of treatment (e.g. 1st, 2nd, 3rd, or ≥ 4th line).
Blood sampling
A blood sample will be taken during a routine blood draw
Early breast cancer
10,000 patients with breast cancer in the neoadjuvant and adjuvant (early breast cancer) setting independent of treatment regimen.
Blood sampling
A blood sample will be taken during a routine blood draw
Interventions
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Blood sampling
A blood sample will be taken during a routine blood draw
Eligibility Criteria
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Inclusion Criteria
* Patients with breast cancer and no evidence of distant metastases with a diagnosis not longer than 91 days before study entry
* Patients, who are able and willing to sign the informed consent form
* Adult women aged ≥18 years
* Patients with the diagnosis of invasive breast cancer (in German: Mammakarzinom, as op-posed to "non-invasive"= ductales Carcinoma in situ; irrespective of status of BC, e.g. TNM, re-ceptor status etc.) and
* Patients, who are willing and able to sign the informed consent form
* Patients with metastatic or locally advanced, inoperable disease proven by clinical measures (i.e. standard imaging)
Exclusion Criteria
* Patients, who are not eligible for observation due to non-availability and/or severe comor-bidities as evaluated by the treating physician
18 Years
99 Years
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Principal Investigators
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Diethelm Wallwiener, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsfrauenklinik Tübingen
Peter Fasching, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Frauenklinik des Universitätsklinikums Erlangen
Sara Brucker, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsfrauenklinik Tübingen
Hans Tesch, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
Andreas Schneeweiss, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Nationales Centrum für Tumorerkrankungen (NCT) Sektion Gynäkologische Onkologie
Locations
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Klinikum Sindelfingen-Böblingen gGmbH
Böblingen, Baden-Wurttemberg, Germany
Klinik für Frauenheilkunde, Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
NCT Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Frauenklinik der St. Vincentius-Kliniken gAG
Karlsruhe, Baden-Wurttemberg, Germany
Praxisklinik am Rosengarten
Mannheim, Baden-Wurttemberg, Germany
medius Klinik Nürtingen
Nürtingen, Baden-Wurttemberg, Germany
Paracelsus Krankenhaus Ruit
Ruit, Baden-Wurttemberg, Germany
Universitätsfrauenklinik Tübingen
Tübingen, Baden-Wurttemberg, Germany
Universitätsfrauenklinik Ulm
Ulm, Baden-Wurttemberg, Germany
St. Vincentius-Kliniken gAG
Karlsruhe, Baden-Württenmberg, Germany
Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
Aschaffenburg, Bavaria, Germany
Hämatologische-onkologische Praxis
Augsburg, Bavaria, Germany
Klinikum Augsburg
Augsburg, Bavaria, Germany
Sozialstiftung Bamberg Klinikum am Bruderwald
Bamberg, Bavaria, Germany
Klinikum Bayreuth
Bayreuth, Bavaria, Germany
DONAUISAR Klinikum
Deggendorf, Bavaria, Germany
Onkologisches Zentrum Donauwörth
Donauwörth, Bavaria, Germany
Rottal-Inn-Kliniken GmbH
Eggenfelden, Bavaria, Germany
Universitätsfrauenklinik Erlangen
Erlangen, Bavaria, Germany
Klinikum Fürth
Fürth, Bavaria, Germany
Klinikum der Universität München Frauenklinik
München, Bavaria, Germany
Frauenklinik und Poliklinik der Technischen Universität München
München, Bavaria, Germany
Caritas-Krankenhaus St. Josef
Regensburg, Bavaria, Germany
Gesundheitszentrum St. Marien GmbH
Amberg, Bayer, Germany
Praxis für Frauenheilkunde und Geburtshilfe
Fürstenwalde, Brandenburg, Germany
Ruppiner Kliniken GmbH, Hochschulklinikum der Med. Hochschule Brandenburg
Neuruppin, Brandenburg, Germany
Christian-Albrechts-Universität Kiel
Kiel, Christian-Albrechts-Universität Kiel, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, City state of Hamburg, Germany
Onkologie Lerchenfeld
Hamburg, City state of Hamburg, Germany
Klinikum Darmstadt Frauenklinik
Darmstadt, Hesse, Germany
Centrum für Hämatologie und Onkologie Bethanien
Frankfurt am Main, Hesse, Germany
Klinikum Kassel GmbH
Kassel, Hesse, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Langen, Hesse, Germany
Klinikum Wetzlar
Wetzlar, Hesse, Germany
Lahn-Dill-Kliniken GmbH Klinikum Wetzlar
Wetzlar, Hesse, Germany
Niels-Stensen-Kliniken
Georgsmarienhütte, Lower Saxony, Germany
Onkologische Schwerpunktpraxis Leer-Emden
Leer, Lower Saxony, Germany
g.SUND Gynäkologie Kompetenzzentrum Stralsund
Stralsund, Mecklenburg-Vorpommern, Germany
Uniklinik RWTH Aachen
Aachen, North Rhine-Westphalia, Germany
Gynäkologie und Geburtshilfe im medizinischen Zentrum Bonn
Bonn, North Rhine-Westphalia, Germany
Marienhospital
Bottrop, North Rhine-Westphalia, Germany
Universitätsfrauenklinik Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, Germany
Herne, North Rhine-Westphalia, Germany
Institut für Versorgungsforschung in der Onkologie GbR
Koblenz, North Rhine-Westphalia, Germany
St. Vincenz-Krankenhaus GmbH
Paderborn, North Rhine-Westphalia, Germany
Praxis Onkologie und Hämatologie
Recklinghausen, North Rhine-Westphalia, Germany
Gesellschaft für Medizinische Studien Würselen
Würselen, North Rhine-Westphalia, Germany
Schwerpunktpraxis für Hämatologie und Onkologie
Kaiserslautern, Rhineland-Palatinate, Germany
Institut für Versorgungsforschung
Mayen, Rhineland-Palatinate, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany
Universitätsklinik Dresden
Dresden, Saxony, Germany
Universitäres Krebszentrum Leipzig
Leipzig, Saxony, Germany
Kreiskrankenhaus Torgau
Torgau, Saxony, Germany
Universitätsklinikum Halle (Saale)
Halle, Saxony-Anhalt, Germany
Klinik für Gynäkologie und Geburtshilfe
Kiel, Schleswig-Holstein, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Charité
Berlin, State of Berlin, Germany
Klinik für Gynäkologie und Geburtshilfe, Helios Kliniken
Berlin, State of Berlin, Germany
Countries
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Central Contacts
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References
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Muller V, Hein A, Hartkopf AD, Fasching PA, Kolberg HC, Hadji P, Tesch H, Haberle L, Ettl J, Luftner D, Wallwiener M, Beckmann MW, Schneeweiss A, Belleville E, Uhrig S, Wimberger P, Hielscher C, Meyer J, Wurmthaler LA, Kurbacher CM, Wuerstlein R, Untch M, Janni W, Taran FA, Lux MP, Wallwiener D, Brucker SY, Fehm TN, Michel LL. Occurrence and characteristics of patients with de novo advanced breast cancer according to patient and tumor characteristics - A retrospective analysis of a real world registry. Eur J Cancer. 2022 Sep;172:13-21. doi: 10.1016/j.ejca.2022.05.015. Epub 2022 Jun 18.
Hein A, Hartkopf AD, Emons J, Lux MP, Volz B, Taran FA, Overkamp F, Hadji P, Tesch H, Haberle L, Ettl J, Luftner D, Wurmthaler LA, Wallwiener M, Muller V, Beckmann MW, Belleville E, Wimberger P, Hielscher C, Kurbacher CM, Wuerstlein R, Thomssen C, Untch M, Fasching PA, Janni W, Fehm TN, Wallwiener D, Brucker SY, Schneeweiss A, Kolberg HC. Prognostic effect of low-level HER2 expression in patients with clinically negative HER2 status. Eur J Cancer. 2021 Sep;155:1-12. doi: 10.1016/j.ejca.2021.06.033. Epub 2021 Jul 23.
Huebner H, Kurbacher CM, Kuesters G, Hartkopf AD, Lux MP, Huober J, Volz B, Taran FA, Overkamp F, Tesch H, Haberle L, Luftner D, Wallwiener M, Muller V, Beckmann MW, Belleville E, Ruebner M, Untch M, Fasching PA, Janni W, Fehm TN, Kolberg HC, Wallwiener D, Brucker SY, Schneeweiss A, Ettl J. Heregulin (HRG) assessment for clinical trial eligibility testing in a molecular registry (PRAEGNANT) in Germany. BMC Cancer. 2020 Nov 11;20(1):1091. doi: 10.1186/s12885-020-07546-1.
Related Links
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Biomarkers in Patients with Metastatic Breast Cancer and the PRAEGNANT Study Network
Other Identifiers
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SEN-01/14
Identifier Type: -
Identifier Source: org_study_id
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