Praegnant Breast Cancer: Early/Advanced/Metastatic

Last updated: January 28, 2026
Sponsor: University Hospital Tuebingen
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Blood sampling

Clinical Study ID

NCT02338167
SEN-01/14
  • Ages 18-99
  • All Genders

Study Summary

Among patients with breast cancer the subgroup of patients with metastases are considered the group of patients with the worst prognosis. Not only regard-ing therapy decisions but also with regard to quality assured healthcare and health economics this entity of patients remains a challenge.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria for the early breast cancer setting:

  • Adult breast cancer patients (age ≥18 years)

  • Patients with breast cancer and no evidence of distant metastases with a diagnosisnot longer than 91 days before study entry

  • Patients, who are able and willing to sign the informed consent form

Inclusion Criteria for the advanced/metastatic setting:

  • Adult women aged ≥18 years

  • Patients with the diagnosis of invasive breast cancer (in German: Mammakarzinom, asop-posed to "non-invasive"= ductales Carcinoma in situ; irrespective of status ofBC, 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 clinicalmeasures (i.e. standard imaging)

Exclusion

Exclusion Criteria:

  • Patients who did not sign the informed consent form

  • Patients, who are not eligible for observation due to non-availability and/or severecomor-bidities as evaluated by the treating physician

Study Design

Total Participants: 13500
Treatment Group(s): 1
Primary Treatment: Blood sampling
Phase:
Study Start date:
June 01, 2014
Estimated Completion Date:
July 31, 2030

Connect with a study center

  • Klinikum Sindelfingen-Böblingen gGmbH

    Böblingen 2947444, Baden-Wurttemberg 2953481 71032
    Germany

    Active - Recruiting

  • Klinik für Frauenheilkunde, Universitätsklinikum Freiburg

    Freiburg im Breisgau 2925177, Baden-Wurttemberg 2953481 79106
    Germany

    Active - Recruiting

  • NCT Heidelberg

    Heidelberg 2907911, Baden-Wurttemberg 2953481 69120
    Germany

    Active - Recruiting

  • Frauenklinik der St. Vincentius-Kliniken gAG

    Karlsruhe 2892794, Baden-Wurttemberg 2953481 76135
    Germany

    Active - Recruiting

  • ViDia Christliche Kliniken Karlsruhe

    Karlsruhe 2892794, Baden-Wurttemberg 2953481 76135
    Germany

    Active - Recruiting

  • Praxisklinik am Rosengarten

    Mannheim 2873891, Baden-Wurttemberg 2953481 68165
    Germany

    Active - Recruiting

  • medius Klinik Nürtingen

    Nürtingen 2861632, Baden-Wurttemberg 2953481 72622
    Germany

    Active - Recruiting

  • Paracelsus Krankenhaus Ruit

    Ruit 2843173, Baden-Wurttemberg 2953481 73760
    Germany

    Site Not Available

  • Universitätsfrauenklinik Tübingen

    Tübingen 2820860, Baden-Wurttemberg 2953481
    Germany

    Active - Recruiting

  • Universitätsfrauenklinik Ulm

    Ulm 2820256, Baden-Wurttemberg 2953481 89081
    Germany

    Active - Recruiting

  • Klinikum Sindelfingen-Böblingen gGmbH

    Böblingen, Baden-Württemberg 71032
    Germany

    Site Not Available

  • Klinik für Frauenheilkunde, Universitätsklinikum Freiburg

    Freiburg, Baden-Württemberg 79106
    Germany

    Site Not Available

  • NCT Heidelberg

    Heidelberg, Baden-Württemberg 69120
    Germany

    Site Not Available

  • Frauenklinik der St. Vincentius-Kliniken gAG

    Karlsruhe, Baden-Württemberg 76135
    Germany

    Active - Recruiting

  • Praxisklinik am Rosengarten

    Mannheim, Baden-Württemberg 68165
    Germany

    Site Not Available

  • medius Klinik Nürtingen

    Nürtingen, Baden-Württemberg 72622
    Germany

    Site Not Available

  • Paracelsus Krankenhaus Ruit

    Ruit, Baden-Württemberg 73760
    Germany

    Site Not Available

  • Universitätsfrauenklinik Tübingen

    Tübingen, Baden-Württemberg
    Germany

    Site Not Available

  • Universitätsfrauenklinik Ulm

    Ulm, Baden-Württemberg 89081
    Germany

    Site Not Available

  • St. Vincentius-Kliniken gAG

    Karlsruhe, Baden-Württenmberg 76135
    Germany

    Site Not Available

  • St. Vincentius-Kliniken gAG

    Karlsruhe 2892794, Baden-Württenmberg 76135
    Germany

    Active - Recruiting

  • Gesundheitszentrum St. Marien GmbH

    Amberg 2956656, Bavaria 2951839 92224
    Germany

    Active - Recruiting

  • Anregiomed gKK Klinikum Ansbach Brustzentrum Westmittelfranken

    Ansbach 2955936, Bavaria 2951839 91522
    Germany

    Active - Recruiting

  • Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg

    Aschaffenburg 2955272, Bavaria 2951839 63739
    Germany

    Site Not Available

  • Hämatologische-onkologische Praxis

    Augsburg 2954172, Bavaria 2951839 86150
    Germany

    Completed

  • Klinikum Augsburg

    Augsburg 2954172, Bavaria 2951839 86156
    Germany

    Active - Recruiting

  • Sozialstiftung Bamberg Klinikum am Bruderwald

    Bamberg 2952984, Bavaria 2951839 96049
    Germany

    Active - Recruiting

  • Klinikum Bayreuth

    Bayreuth 2951825, Bavaria 2951839 95445
    Germany

    Active - Recruiting

  • DONAUISAR Klinikum

    Deggendorf 2938540, Bavaria 2951839 94469
    Germany

    Active - Recruiting

  • Onkologisches Zentrum Donauwörth

    Donauwörth 2936253, Bavaria 2951839 86609
    Germany

    Active - Recruiting

  • Rottal-Inn-Kliniken GmbH

    Eggenfelden 2933115, Bavaria 2951839 84307
    Germany

    Active - Recruiting

  • Universitätsfrauenklinik Erlangen

    Erlangen 2929567, Bavaria 2951839 91012
    Germany

    Active - Recruiting

  • Klinikum Fürth

    Fürth 2923544, Bavaria 2951839 90766
    Germany

    Active - Recruiting

  • MVZ am Klinikum Aschaffenburg - Zweigpraxis für Hämatologie und Onkologie

    Hösbach 2898494, Bavaria 2951839 63768
    Germany

    Active - Recruiting

  • Frauenklinik und Poliklinik der Technischen Universität München

    München 2867713, Bavaria 2951839 81675
    Germany

    Active - Recruiting

  • Klinikum der Universität München Frauenklinik

    München 2867713, Bavaria 2951839 81337
    Germany

    Active - Recruiting

  • Onkologie Elisenhof, München

    München 2867713, Bavaria 2951839 80335
    Germany

    Completed

  • Caritas-Krankenhaus St. Josef

    Regensburg 2849483, Bavaria 2951839 93053
    Germany

    Active - Recruiting

  • Universitätsklinikum Würzburg

    Würzburg 2805615, Bavaria 2951839 97080
    Germany

    Active - Recruiting

  • Gesundheitszentrum St. Marien GmbH

    Amberg, Bayer 92224
    Germany

    Site Not Available

  • Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg

    Aschaffenburg, Bayern 63739
    Germany

    Site Not Available

  • Hämatologische-onkologische Praxis

    Augsburg, Bayern 86150
    Germany

    Active - Recruiting

  • Klinikum Augsburg

    Augsburg, Bayern 86156
    Germany

    Site Not Available

  • Sozialstiftung Bamberg Klinikum am Bruderwald

    Bamberg, Bayern 96049
    Germany

    Site Not Available

  • Klinikum Bayreuth

    Bayreuth, Bayern 95445
    Germany

    Site Not Available

  • DONAUISAR Klinikum

    Deggendorf, Bayern 94469
    Germany

    Site Not Available

  • Onkologisches Zentrum Donauwörth

    Donauwörth, Bayern 86609
    Germany

    Site Not Available

  • Rottal-Inn-Kliniken GmbH

    Eggenfelden, Bayern 84307
    Germany

    Site Not Available

  • Universitätsfrauenklinik Erlangen

    Erlangen, Bayern 91012
    Germany

    Site Not Available

  • Klinikum Fürth

    Fürth, Bayern 90766
    Germany

    Site Not Available

  • Frauenklinik und Poliklinik der Technischen Universität München

    München, Bayern 81675
    Germany

    Active - Recruiting

  • Klinikum der Universität München Frauenklinik

    München, Bayern 80337
    Germany

    Active - Recruiting

  • Onkologie Elisenhof

    München, Bayern 80335
    Germany

    Site Not Available

  • Caritas-Krankenhaus St. Josef

    Regensburg, Bayern 93053
    Germany

    Site Not Available

  • Praxis für Frauenheilkunde und Geburtshilfe

    Fürstenwalde, Brandenburg 015517
    Germany

    Site Not Available

  • Ruppiner Kliniken GmbH, Hochschulklinikum der Med. Hochschule Brandenburg

    Neuruppin, Brandenburg 16816
    Germany

    Site Not Available

  • Praxis für Frauenheilkunde und Geburtshilfe

    Fürstenwalde 2923588, Brandenburg 2945356 015517
    Germany

    Active - Recruiting

  • Ruppiner Kliniken GmbH, Hochschulklinikum der Med. Hochschule Brandenburg

    Neuruppin 2864276, Brandenburg 2945356 16816
    Germany

    Active - Recruiting

  • Immanuel Klinik und Poliklinik Rüdersdorf GmbH

    Rüdersdorf 2843408, Brandenburg 2945356 15562
    Germany

    Active - Recruiting

  • Christian-Albrechts-Universität Kiel

    Kiel, Christian-Albrechts-Universität Kiel 24105
    Germany

    Active - Recruiting

  • Christian-Albrechts-Universität Kiel

    Kiel 2891122, Christian-Albrechts-Universität Kiel 24105
    Germany

    Active - Recruiting

  • Onkologie Lerchenfeld

    Hamburg 2911298, Hamburg 2911297 22081
    Germany

    Completed

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg 2911298, Hamburg 2911297 20246
    Germany

    Active - Recruiting

  • Klinikum Darmstadt Frauenklinik

    Darmstadt 2938913, Hesse 2905330 64283
    Germany

    Active - Recruiting

  • Centrum für Hämatologie und Onkologie Bethanien

    Frankfurt am Main 2925533, Hesse 2905330 60389
    Germany

    Active - Recruiting

  • Klinikum Kassel GmbH

    Kassel 2892518, Hesse 2905330 34125
    Germany

    Active - Recruiting

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Langen 2881279, Hesse 2905330 63225
    Germany

    Active - Recruiting

  • Klinikum Wetzlar

    Wetzlar 2809889, Hesse 2905330 35578
    Germany

    Active - Recruiting

  • Lahn-Dill-Kliniken GmbH Klinikum Wetzlar

    Wetzlar 2809889, Hesse 2905330 35578
    Germany

    Completed

  • Klinikum Darmstadt Frauenklinik

    Darmstadt, Hessen 64283
    Germany

    Site Not Available

  • Centrum für Hämatologie und Onkologie Bethanien

    Frankfurt, Hessen 60389
    Germany

    Site Not Available

  • Klinikum Kassel GmbH

    Kassel, Hessen 34125
    Germany

    Site Not Available

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Langen, Hessen 63225
    Germany

    Site Not Available

  • Sana Klinikum Offenbach GmbH

    Offenbach, Hessen 63069
    Germany

    Site Not Available

  • Klinikum Wetzlar

    Wetzlar, Hessen 35578
    Germany

    Active - Recruiting

  • Lahn-Dill-Kliniken GmbH Klinikum Wetzlar

    Wetzlar, Hessen 35578
    Germany

    Site Not Available

  • Niels-Stensen-Kliniken

    Georgsmarienhütte 2921242, Lower Saxony 2862926 49124
    Germany

    Active - Recruiting

  • Onkologische Schwerpunktpraxis Leer-Emden

    Leer 2879697, Lower Saxony 2862926 26789
    Germany

    Active - Recruiting

  • g.SUND Gynäkologie Kompetenzzentrum Stralsund

    Stralsund, Mecklenburg-Vorpommern 18435
    Germany

    Site Not Available

  • g.SUND Gynäkologie Kompetenzzentrum Stralsund

    Stralsund 2826287, Mecklenburg-Vorpommern 2872567 18435
    Germany

    Active - Recruiting

  • Niels-Stensen-Kliniken

    Georgsmarienhütte, Niedersachsen 49124
    Germany

    Site Not Available

  • Gynäkologisch-Onkologische Praxis am Pelikanplatz

    Hannover, Niedersachsen 30177
    Germany

    Site Not Available

  • Onkologische Schwerpunktpraxis Leer-Emden

    Leer, Niedersachsen 26789
    Germany

    Site Not Available

  • Uniklinik RWTH Aachen

    Aachen, Nordrhein-Westfalen 52074
    Germany

    Site Not Available

  • Gynäkologie und Geburtshilfe im medizinischen Zentrum Bonn

    Bonn, Nordrhein-Westfalen 53111
    Germany

    Site Not Available

  • Marienhospital

    Bottrop, Nordrhein-Westfalen 46236
    Germany

    Site Not Available

  • Universitätsfrauenklinik Düsseldorf

    Düsseldorf, Nordrhein-Westfalen 40225
    Germany

    Site Not Available

  • Kliniken Essen-Mitte

    Essen, Nordrhein-Westfalen 45136
    Germany

    Site Not Available

  • empty

    Herne, Nordrhein-Westfalen 44623
    Germany

    Site Not Available

  • Helios Klinikum

    Krefeld, Nordrhein-Westfalen 47805
    Germany

    Site Not Available

  • St. Vincenz-Krankenhaus GmbH

    Paderborn, Nordrhein-Westfalen 33098
    Germany

    Site Not Available

  • Praxis Onkologie und Hämatologie

    Recklinghausen, Nordrhein-Westfalen 45657
    Germany

    Site Not Available

  • Gesellschaft für Medizinische Studien Würselen

    Würselen, Nordrhein-Westfalen 52146
    Germany

    Site Not Available

  • Uniklinik RWTH Aachen

    Aachen 3247449, North Rhine-Westphalia 2861876 52074
    Germany

    Active - Recruiting

  • Gynäkologie und Geburtshilfe im medizinischen Zentrum Bonn

    Bonn 2946447, North Rhine-Westphalia 2861876 53111
    Germany

    Active - Recruiting

  • Marienhospital

    Bottrop 2945756, North Rhine-Westphalia 2861876 46236
    Germany

    Active - Recruiting

  • Universitätsfrauenklinik Düsseldorf

    Düsseldorf 2934246, North Rhine-Westphalia 2861876 40225
    Germany

    Active - Recruiting

  • Kliniken Essen-Mitte

    Essen 2928810, North Rhine-Westphalia 2861876 45136
    Germany

    Completed

  • Herne 2905891, North Rhine-Westphalia 2861876 44623
    Germany

    Completed

  • Institut für Versorgungsforschung in der Onkologie GbR

    Koblenz, North Rhine-Westphalia 2861876 56068
    Germany

    Active - Recruiting

  • St. Vincenz-Krankenhaus GmbH

    Paderborn 2855745, North Rhine-Westphalia 2861876 33098
    Germany

    Active - Recruiting

  • Praxis Onkologie und Hämatologie

    Recklinghausen 2849647, North Rhine-Westphalia 2861876 45657
    Germany

    Completed

  • Gesellschaft für Medizinische Studien Würselen

    Würselen 2805644, North Rhine-Westphalia 2861876 52146
    Germany

    Active - Recruiting

  • Schwerpunktpraxis für Hämatologie und Onkologie

    Kaiserslautern, Rheinland-Pfalz 67655
    Germany

    Site Not Available

  • Institut für Versorgungsforschung

    Mayen, Rheinland-Pfalz 56727
    Germany

    Site Not Available

  • Klinikum Mutterhaus der Borromäerinnen

    Trier, Rheinland-Pfalz 54290
    Germany

    Site Not Available

  • Schwerpunktpraxis für Hämatologie und Onkologie

    Kaiserslautern 2894003, Rhineland-Palatinate 2847618 67655
    Germany

    Active - Recruiting

  • Institut für Versorgungsforschung

    Mayen 2872649, Rhineland-Palatinate 2847618 56727
    Germany

    Active - Recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz, Sachsen 09116
    Germany

    Site Not Available

  • Universitätsklinik Dresden

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Universitäres Krebszentrum Leipzig

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • Kreiskrankenhaus Torgau

    Torgau, Sachsen 04860
    Germany

    Site Not Available

  • Universitätsklinikum Halle (Saale)

    Halle, Sachsen-Anhalt 06120
    Germany

    Site Not Available

  • Klinikum Chemnitz gGmbH

    Chemnitz 2940132, Saxony 2842566 09116
    Germany

    Active - Recruiting

  • Universitätsklinik Dresden

    Dresden 2935022, Saxony 2842566 01307
    Germany

    Active - Recruiting

  • Universitäres Krebszentrum Leipzig

    Leipzig 2879139, Saxony 2842566 04103
    Germany

    Active - Recruiting

  • Kreiskrankenhaus Torgau

    Torgau 2821807, Saxony 2842566 04860
    Germany

    Active - Recruiting

  • Universitätsklinikum Halle (Saale)

    Halle 2911522, Saxony-Anhalt 2842565 06120
    Germany

    Active - Recruiting

  • Klinik für Gynäkologie und Geburtshilfe

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein 23538
    Germany

    Site Not Available

  • Klinik für Gynäkologie und Geburtshilfe

    Kiel 2891122, Schleswig-Holstein 2838632 24105
    Germany

    Completed

  • Universitätsklinikum Schleswig-Holstein

    Lübeck 2875601, Schleswig-Holstein 2838632 23538
    Germany

    Active - Recruiting

  • Charité

    Berlin 2950159, State of Berlin 2950157 10117
    Germany

    Completed

  • Klinik für Gynäkologie und Geburtshilfe, Helios Kliniken

    Berlin 2950159, State of Berlin 2950157 13125
    Germany

    Active - Recruiting

  • MediOnko-Institut GbR

    Berlin 2950159, State of Berlin 2950157 10367
    Germany

    Active - Recruiting

  • Charité

    Berlin, 10117
    Germany

    Active - Recruiting

  • Klinik für Gynäkologie und Geburtshilfe, Helios Kliniken

    Berlin, 13125
    Germany

    Site Not Available

  • Onkologie Lerchenfeld

    Hamburg, 22081
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Active - Recruiting

  • medius KLINIKEN gGmbH, medius KLINIK Ostfildern-Ruit

    Ostfildern 3336892, 73760
    Germany

    Active - Recruiting

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