Praegnant Breast Cancer: Early/Advanced/Metastatic

NCT02338167 | Recruiting DMC

• 1 other identifier: SEN-01/14
• Study Type: observational
• Target: 13,500
• Locations: 1 country
• Sites: 61

Brief 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.

Conditions

Advanced/Metastatic Breast Cancer; Breast Cancer (Early Breast Cancer)

Outcome Measures

Primary Outcomes (2)

• MBC (Metastatic Breast Cancer): Discovery of biomarkers, which predict progression free survival (PFS)

  Analyses will be done separately for each therapy line. Biomarkers include gene expression profiling of the primary tumor and the corresponding metastases, somatic mutations, germline genetic variation, epigenetic changes and miRNA variation up to a total of 500,000 biomarkers.

  PFS defined as the time to the first progression after study inclusion from the last time of progression before or at study entry

• EBC (Early Breast Cancer): Assessment of disease free sur-vival (DFS)

  DFS defined as the time to the first disease recurrence after study inclusion from time of primary diagnosis before or at study entry

  up to 60 months

Secondary Outcomes (24)

• MBC: Assessment of overall survival (OS)

  OS is defined as the time to death from the date of the last progression before or at study entry.

• MBC: Assessment of breast cancer specific survival (BCSS)

  Time to death from the date of the last progression before or at study entry.

• MBC: Objective response

  up to 60 months

• MBC: Description of therapies used in the metastatic setting

  after 60 months (after study completion)

• MBC: Quality of life

  Study entry and every 3 month or following a change of a therapy line(event-associated, e.g. after progression) until Month 24. Every 6 months from Month 24 until Death or withdrawal of consent

Other Outcomes (10)

• Correlation of the incidence of depression with germline gentic variation and therapies and gene expression from leukocytes.

  Study entry and following a change of a therapy line (event-associated, e.g. after progression) up to month 60

• Correlation of gene alterations (mutations and or amplifications) and gene expres-sion between primary tumor and metastatic tumor for the prediction of side effects and prognosis.

  after 60 months (after study completion)

• Correlation of gene alterations (mutations and or amplifications) and gene expres-sion between primary tumor, metastatic tumor and circulating tumor cells (CTCs).

  Study entry and following a change of a therapy line (event-associated, e.g. after progression) up to month 60

Study Arms (2)

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).

Procedure: Blood sampling

Early breast cancer

10,000 patients with breast cancer in the neoadjuvant and adjuvant (early breast cancer) setting independent of treatment regimen.

Procedure: Blood sampling

Interventions

Blood sampling PROCEDURE

A blood sample will be taken during a routine blood draw

Advanced/metastatic breast cancer; Early breast cancer

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10,000 patients with breast cancer in the neoadjuvant and adjuvant (early breast cancer) setting independent of treatment regimen. 3500 patients with locally advanced/metastatic breast cancer in any line of treatment (e.g. 1st, 2nd, 3rd, or ≥ 4th line). A patient can only participate after providing informed consent.

You may qualify if:

• Adult breast cancer patients (age ≥18 years)
• 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)

You may not qualify if:

• Patients who did not sign the informed consent form
• Patients, who are not eligible for observation due to non-availability and/or severe comor-bidities as evaluated by the treating physician

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (61)

Klinikum Sindelfingen-Böblingen gGmbH

Böblingen, Baden-Wurttemberg, 71032, Germany

RECRUITING

Klinik für Frauenheilkunde, Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

RECRUITING

NCT Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

ViDia Christliche Kliniken Karlsruhe

Karlsruhe, Baden-Wurttemberg, 76135, Germany

RECRUITING

Praxisklinik am Rosengarten

Mannheim, Baden-Wurttemberg, 68165, Germany

RECRUITING

medius Klinik Nürtingen

Nürtingen, Baden-Wurttemberg, 72622, Germany

RECRUITING

Universitätsfrauenklinik Tübingen

Tübingen, Baden-Wurttemberg, Germany

RECRUITING

Universitätsfrauenklinik Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

Gesundheitszentrum St. Marien GmbH

Amberg, Bavaria, 92224, Germany

RECRUITING

Anregiomed gKK Klinikum Ansbach Brustzentrum Westmittelfranken

Ansbach, Bavaria, 91522, Germany

RECRUITING

Hämatologische-onkologische Praxis

Augsburg, Bavaria, 86150, Germany

COMPLETED

Klinikum Augsburg

Augsburg, Bavaria, 86156, Germany

RECRUITING

Sozialstiftung Bamberg Klinikum am Bruderwald

Bamberg, Bavaria, 96049, Germany

RECRUITING

Klinikum Bayreuth

Bayreuth, Bavaria, 95445, Germany

RECRUITING

DONAUISAR Klinikum

Deggendorf, Bavaria, 94469, Germany

RECRUITING

Onkologisches Zentrum Donauwörth

Donauwörth, Bavaria, 86609, Germany

RECRUITING

Rottal-Inn-Kliniken GmbH

Eggenfelden, Bavaria, 84307, Germany

RECRUITING

Universitätsfrauenklinik Erlangen

Erlangen, Bavaria, 91012, Germany

RECRUITING

Klinikum Fürth

Fürth, Bavaria, 90766, Germany

RECRUITING

MVZ am Klinikum Aschaffenburg - Zweigpraxis für Hämatologie und Onkologie

Hösbach, Bavaria, 63768, Germany

RECRUITING

Onkologie Elisenhof, München

München, Bavaria, 80335, Germany

COMPLETED

Klinikum der Universität München Frauenklinik

München, Bavaria, 81337, Germany

RECRUITING

Frauenklinik und Poliklinik der Technischen Universität München

München, Bavaria, 81675, Germany

RECRUITING

Caritas-Krankenhaus St. Josef

Regensburg, Bavaria, 93053, Germany

RECRUITING

Universitätsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

Praxis für Frauenheilkunde und Geburtshilfe

Fürstenwalde, Brandenburg, 015517, Germany

RECRUITING

Ruppiner Kliniken GmbH, Hochschulklinikum der Med. Hochschule Brandenburg

Neuruppin, Brandenburg, 16816, Germany

RECRUITING

Immanuel Klinik und Poliklinik Rüdersdorf GmbH

Rüdersdorf, Brandenburg, 15562, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

RECRUITING

Onkologie Lerchenfeld

Hamburg, Hamburg, 22081, Germany

COMPLETED

Klinikum Darmstadt Frauenklinik

Darmstadt, Hesse, 64283, Germany

RECRUITING

Centrum für Hämatologie und Onkologie Bethanien

Frankfurt am Main, Hesse, 60389, Germany

RECRUITING

Klinikum Kassel GmbH

Kassel, Hesse, 34125, Germany

RECRUITING

Gemeinschaftspraxis für Hämatologie und Onkologie

Langen, Hesse, 63225, Germany

RECRUITING

Lahn-Dill-Kliniken GmbH Klinikum Wetzlar

Wetzlar, Hesse, 35578, Germany

COMPLETED

Niels-Stensen-Kliniken

Georgsmarienhütte, Lower Saxony, 49124, Germany

RECRUITING

Onkologische Schwerpunktpraxis Leer-Emden

Leer, Lower Saxony, 26789, Germany

RECRUITING

g.SUND Gynäkologie Kompetenzzentrum Stralsund

Stralsund, Mecklenburg-Vorpommern, 18435, Germany

RECRUITING

Uniklinik RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

Gynäkologie und Geburtshilfe im medizinischen Zentrum Bonn

Bonn, North Rhine-Westphalia, 53111, Germany

RECRUITING

Marienhospital

Bottrop, North Rhine-Westphalia, 46236, Germany

RECRUITING

Universitätsfrauenklinik Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45136, Germany

COMPLETED

Unknown Facility

Herne, North Rhine-Westphalia, 44623, Germany

COMPLETED

Institut für Versorgungsforschung in der Onkologie GbR

Koblenz, North Rhine-Westphalia, 56068, Germany

RECRUITING

St. Vincenz-Krankenhaus GmbH

Paderborn, North Rhine-Westphalia, 33098, Germany

RECRUITING

Praxis Onkologie und Hämatologie

Recklinghausen, North Rhine-Westphalia, 45657, Germany

COMPLETED

Gesellschaft für Medizinische Studien Würselen

Würselen, North Rhine-Westphalia, 52146, Germany

RECRUITING

Schwerpunktpraxis für Hämatologie und Onkologie

Kaiserslautern, Rhineland-Palatinate, 67655, Germany

RECRUITING

Institut für Versorgungsforschung

Mayen, Rhineland-Palatinate, 56727, Germany

RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, Saxony, 09116, Germany

RECRUITING

Universitätsklinik Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

Universitäres Krebszentrum Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

Kreiskrankenhaus Torgau

Torgau, Saxony, 04860, Germany

RECRUITING

Universitätsklinikum Halle (Saale)

Halle, Saxony-Anhalt, 06120, Germany

RECRUITING

Klinik für Gynäkologie und Geburtshilfe

Kiel, Schleswig-Holstein, 24105, Germany

COMPLETED

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

Charité

Berlin, State of Berlin, 10117, Germany

COMPLETED

MediOnko-Institut GbR

Berlin, State of Berlin, 10367, Germany

RECRUITING

Klinik für Gynäkologie und Geburtshilfe, Helios Kliniken

Berlin, State of Berlin, 13125, Germany

RECRUITING

medius KLINIKEN gGmbH, medius KLINIK Ostfildern-Ruit

Ostfildern, 73760, Germany

RECRUITING

Related Publications (3)

• 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.

  PMID: 35728342 DERIVED

• 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.

  PMID: 34311211 DERIVED

• 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.

  PMID: 33176725 DERIVED

Related Links

• Biomarkers in Patients with Metastatic Breast Cancer and the PRAEGNANT Study Network

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Diethelm Wallwiener, Prof. Dr.

  Universitätsfrauenklinik Tübingen

  PRINCIPAL INVESTIGATOR

• Peter Fasching, Prof. Dr.

  Frauenklinik des Universitätsklinikums Erlangen

  PRINCIPAL INVESTIGATOR

• Sara Brucker, Prof. Dr.

  Universitätsfrauenklinik Tübingen

  PRINCIPAL INVESTIGATOR

• Hans Tesch, Prof. Dr.

  Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus Frankfurt

  PRINCIPAL INVESTIGATOR

• Andreas Schneeweiss, Prof. Dr.

  Nationales Centrum für Tumorerkrankungen (NCT) Sektion Gynäkologische Onkologie Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erik Belleville, PhD

CONTACT

+49 931 359200; belleville@clin-sol.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 14, 2015
• Study Start: June 1, 2014
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

DE (61)