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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| Early breast cancer | 10,000 patients with breast cancer in the neoadjuvant and adjuvant (early breast cancer) setting independent of treatment regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Procedure | A blood sample will be taken during a routine blood draw |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of the incidence of depression with germline gentic variation and therapies and gene expression from leukocytes. | Depression Inventory values will be associated with blood biomarkers, single nucleotide polymorphisms and therapies. | Study entry and following a change of a therapy line (event-associated, e.g. after progression) up to month 60 |
Inclusion Criteria for the early breast cancer setting:
Inclusion Criteria for the advanced/metastatic setting:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erik Belleville, PhD | Contact | +49 931 359200 | 36 | belleville@clin-sol.com |
| Name | Affiliation | Role |
|---|---|---|
| Diethelm Wallwiener, Prof. Dr. | Universitätsfrauenklinik Tübingen | Principal Investigator |
| Peter Fasching, Prof. Dr. | Frauenklinik des Universitätsklinikums Erlangen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Sindelfingen-Böblingen gGmbH | Recruiting | Böblingen | Baden-Wurttemberg | 71032 | Germany | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41925922 | Derived | Horner M, Tretschock LM, John N, Ziegler P, Haberle L, Uhrig S, Goossens C, Amann N, Cieslik JP, Dannehl D, Deutsch TM, Dimpfl M, Ehlert M, Eichstadt K, Englisch A, Kopke MB, Kruckel A, Link T, Muller A, Reinhardt K, Roth J, Schaffler H, Sych L, Tegeler CM, Wichmann C, Banys-Paluchowski M, Princk H, Rody A, Brucker SY, Ditsch N, Ettl J, Fehm T, Hack CC, Hadji P, Hein A, Janni WW, Kolberg HC, Luftner D, Lux MP, Muller V, Schneeweiss A, Taran FA, Tesch H, Wallwiener D, Marme F, Seitz S, Belleville E, Hartkopf A, Michel LL, Wallwiener M, Fasching PA, Tauber N. Alpelisib and Fulvestrant in PIK3CA-mutated hormone receptor-positive HER2-negative advanced breast cancer included in the German PRAEGNANT trial. Breast Cancer Res Treat. 2026 Apr 2;217(1):9. doi: 10.1007/s10549-026-07939-z. | |
| 35728342 |
| Label | URL |
|---|---|
| Biomarkers in Patients with Metastatic Breast Cancer and the PRAEGNANT Study Network | View source |
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Blood samples
BCSS is defined as the time to to death due to breast cancer from the date of the last progression before or at study entry. |
| Time to death from the date of the last progression before or at study entry. |
| MBC: Objective response | Objective response is defined as the best-documented response to the therapy started at study entry or the last therapy started before study entry. | up to 60 months |
| MBC: Description of therapies used in the metastatic setting | Therapies will be categorized and descriptive statistics will be presented. | after 60 months (after study completion) |
| MBC: Quality of life | Assessed with EORTC QlQ-C30 and Visual Analog Scala | 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 |
| MBC: Therapy adherence | Defined as the percentage of patients in which treat-ments which are terminated as per patients' wish or because of treatment related side effect. | up to 60 months |
| MBC: Influencing Factors of Depression in patients with metastatic breast cancer | Depression will be assessed by patient reported questionnaires e.g. CESD-R. | 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 |
| MBC: Incidence of adverse events, serious adverse events will be reported. | According to NCI Common Toxicity Criteria Version 4.03. | up to 60 months |
| MBC: Percentage of women, who will receive results of molecular tests undertaken in the context of the scientific objectives of this trial. | Number of patients who will receive molecular testing results compared to the total number of included patients. | Once at end of study |
| MBC: Feasibility and satisfaction regarding receipt of molecular testing results (including hereditary genetic alterations) | Assessed with a physician and patient questionnaire and documentation of possible confirmatory testing for changes in therapy or eligibility for interventional clinical trial screening. | Once at end of study |
| MBC: Health economics for women with metastatic and/or locally advanced, inoperable breast cancer. | EORTC QLQ C-30 (Version 3.0) (among others) and actu-al documented costs of diagnostic procedures, therapies, treatment of side effects and care for tumor-associated symptoms will be used to calculate health care costs, quality adjusted life years (QALY) and incremental cost effectiveness ratios (ICER) between patient groups. | 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 |
| MBC: Patient reported influencing factors on therapy adherence in patients metastatic and/or locally advanced, inoperable breast cancer. | Patient reported adherence for orally administered therapies will be assessed with suitable questionnaires. | 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 |
| EBC: Assessment of distant disease-free survival (DDFS) | DDFS defined as the time to the first distant disease recurrence after study inclusion from time of primary diagnosis before or at study entry. | Up to 60 months |
| EBC: Quality of life | Assessed with EORTC QLQ C-30 (Version 3.0), EORTC QLQ-BR23 and the EQ-Visual Analog Scale (VAS) | 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 |
| EBC: Assessment of overall survival (OS) | OS is defined as the time to death from the date of the primary diagnosis before or at study entry. | OS is defined as the time to death from the date of the last progression before or at study entry. |
| EBC: Assessment of breast cancer specific survival (BCSS) | BCSS is defined as the time to death due to breast cancer from the date of the primary diagnosis before or at study entry. | Time to death due to breast cancer from the date of the primary diagnosis before or at study entry. |
| EBC: Description of therapies used in the early breast cancer setting | Therapies will be categorized, and descriptive statistics will be presented. | after 60 months (after study completion) |
| EBC: Percentage of women, who will receive results of molecular tests undertaken in the context of the scientific objectives of this trial. | Number of patients who will receive molecular testing results compared to the total number of included pa-tients. | Once at end of study |
| EBC: Feasibility and satisfaction regarding receipt of molecular testing results (including hereditary genetic alterations) | Assessed with a physician and patient questionnaire and documentation of possible confirmatory testing for changes in therapy or eligibility for interventional clinical trial screening. | Once at end of study |
| EBC: Therapy adherence | Defined as the percentage of patients in which treat-ments which are terminated as per patients' wish or because of treatment related side effect | up to 60 months |
| EBC: Health economics for women with breast cancer | EORTC QLQ C-30 (Version 3.0) (among others) and actu-al documented costs of diagnostic procedures, thera-pies, treatment of side effects and care for tumor-associated symptoms will be used to calculate health care costs, quality adjusted life years (QALY) and incre-mental cost effectiveness ratios (ICER) between patient groups. | up to 60 months |
| EBC: Influencing Factors of Depression in patients with breast cancer | Depression will be assessed by patient reported ques-tionnaires e.g. CESD-R. | 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 |
| EBC: Patient reported influencing factors on therapy adherence in patients with early breast cancer. | Patient reported adherence for orally administered therapies will be assessed with suitable questionnaires. | 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 |
| EBC: Incidence of adverse events, serious ad-verse events will be reported. | NCI Common Toxicity Criteria Version 4.03. | up to 60 months |
| 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. | DNA and RNA of the primary tumor will be extracted of archival formalin fixed, paraffin embedded tumor samples and analyzed mutations, mutation changes, and differentially expressed genes. Additionally, FFPE will be used for the construction of a TMA for antibody staining. | 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). | Circulating tumor cells (CTC) from selected patients will be analyzed for mutations and gene amplifications. Findings will be compared to mutations assessed from FFPE tumor material. | 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) between primary tumor, metastatic tumor and circulating tumor DNA. | Circulating DNA (ctDNA) will be analyzed for genetic variation and compared to mutations assessed from FFPE tumor material. | after 60 months (after study completion) |
| Prediction of therapy response, prognosis and side effects with germline Single Nucleotid Polymorphisms | Germline DNA will be used as reference for the genetic analysis of the tumor, CTCs and ctDNA. Additionally ge-nome-wide SNPs will be assessed and used for a ge-nome-wide association study. | Study entry and following a change of a therapy line (event-associated, e.g. after progression) up to month 60 |
| Correlation of blood protein biomarkers with side effects, and progression. | EGFR (1068), HSP27 (pS78), IL-1a, IL-1b, IL-2, IL-6, Il-8, PAI-1, sEGFR, ERK1/2, mTOR, TNF-a, TNF-b. P1NP, CTX, Vitamin D, PTH, OPG, RANKL, Sclerostin, DKK-1. | Study entry and following a change of a therapy line (event-associated, e.g. after progression) up to month 60. |
| Identification of risk factors for the development of metastatic disease in healthy women. | Patients will be matched to a pool of controls, which are not part of the PRAEGNANT study, but which have been recruited during the same time. | after 60 months (after study completion) |
| Influencing Factors of Physical Activity, Mental factors and Nutrition in patients with metastatic breast cancer | Physical activity and nutrition will be assessed with patient reported questionnaires, e.g. IPAQ and ER2. | 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 |
| Time to progression from the beginning of subsequent therapy lines until the next progression. | All molecular and other measures that might predict prognosis will be associated with the-se times to progression as well. | up to 60 months |
| Time to death from the beginning of subsequent therapy lines | All molecular and other measures that might predict prognosis will be associated with these times to death as well. | up to 60 months |
| 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 |
| Klinik für Frauenheilkunde, Universitätsklinikum Freiburg |
| Recruiting |
| Freiburg im Breisgau |
| Baden-Wurttemberg |
| 79106 |
| Germany |
| NCT Heidelberg | Recruiting | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| ViDia Christliche Kliniken Karlsruhe | Recruiting | Karlsruhe | Baden-Wurttemberg | 76135 | Germany |
| Praxisklinik am Rosengarten | Recruiting | Mannheim | Baden-Wurttemberg | 68165 | Germany |
| medius Klinik Nürtingen | Recruiting | Nürtingen | Baden-Wurttemberg | 72622 | Germany |
| Universitätsfrauenklinik Tübingen | Recruiting | Tübingen | Baden-Wurttemberg | Germany |
| Universitätsfrauenklinik Ulm | Recruiting | Ulm | Baden-Wurttemberg | 89081 | Germany |
| Gesundheitszentrum St. Marien GmbH | Recruiting | Amberg | Bavaria | 92224 | Germany |
| Anregiomed gKK Klinikum Ansbach Brustzentrum Westmittelfranken | Recruiting | Ansbach | Bavaria | 91522 | Germany |
| Hämatologische-onkologische Praxis | Completed | Augsburg | Bavaria | 86150 | Germany |
| Klinikum Augsburg | Recruiting | Augsburg | Bavaria | 86156 | Germany |
| Sozialstiftung Bamberg Klinikum am Bruderwald | Recruiting | Bamberg | Bavaria | 96049 | Germany |
| Klinikum Bayreuth | Recruiting | Bayreuth | Bavaria | 95445 | Germany |
| DONAUISAR Klinikum | Recruiting | Deggendorf | Bavaria | 94469 | Germany |
| Onkologisches Zentrum Donauwörth | Recruiting | Donauwörth | Bavaria | 86609 | Germany |
| Rottal-Inn-Kliniken GmbH | Recruiting | Eggenfelden | Bavaria | 84307 | Germany |
| Universitätsfrauenklinik Erlangen | Recruiting | Erlangen | Bavaria | 91012 | Germany |
| Klinikum Fürth | Recruiting | Fürth | Bavaria | 90766 | Germany |
| MVZ am Klinikum Aschaffenburg - Zweigpraxis für Hämatologie und Onkologie | Recruiting | Hösbach | Bavaria | 63768 | Germany |
| Onkologie Elisenhof, München | Completed | München | Bavaria | 80335 | Germany |
| Klinikum der Universität München Frauenklinik | Recruiting | München | Bavaria | 81337 | Germany |
| Frauenklinik und Poliklinik der Technischen Universität München | Recruiting | München | Bavaria | 81675 | Germany |
| Caritas-Krankenhaus St. Josef | Recruiting | Regensburg | Bavaria | 93053 | Germany |
| Universitätsklinikum Würzburg | Recruiting | Würzburg | Bavaria | 97080 | Germany |
| Praxis für Frauenheilkunde und Geburtshilfe | Recruiting | Fürstenwalde | Brandenburg | 015517 | Germany |
| Ruppiner Kliniken GmbH, Hochschulklinikum der Med. Hochschule Brandenburg | Recruiting | Neuruppin | Brandenburg | 16816 | Germany |
| Immanuel Klinik und Poliklinik Rüdersdorf GmbH | Recruiting | Rüdersdorf | Brandenburg | 15562 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Recruiting | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
| Onkologie Lerchenfeld | Completed | Hamburg | Free and Hanseatic City of Hamburg | 22081 | Germany |
| Klinikum Darmstadt Frauenklinik | Recruiting | Darmstadt | Hesse | 64283 | Germany |
| Centrum für Hämatologie und Onkologie Bethanien | Recruiting | Frankfurt am Main | Hesse | 60389 | Germany |
| Klinikum Kassel GmbH | Recruiting | Kassel | Hesse | 34125 | Germany |
| Gemeinschaftspraxis für Hämatologie und Onkologie | Recruiting | Langen | Hesse | 63225 | Germany |
| Lahn-Dill-Kliniken GmbH Klinikum Wetzlar | Completed | Wetzlar | Hesse | 35578 | Germany |
| Niels-Stensen-Kliniken | Recruiting | Georgsmarienhütte | Lower Saxony | 49124 | Germany |
| Onkologische Schwerpunktpraxis Leer-Emden | Recruiting | Leer | Lower Saxony | 26789 | Germany |
| g.SUND Gynäkologie Kompetenzzentrum Stralsund | Recruiting | Stralsund | Mecklenburg-Vorpommern | 18435 | Germany |
| Uniklinik RWTH Aachen | Recruiting | Aachen | North Rhine-Westphalia | 52074 | Germany |
| Gynäkologie und Geburtshilfe im medizinischen Zentrum Bonn | Recruiting | Bonn | North Rhine-Westphalia | 53111 | Germany |
| Marienhospital | Recruiting | Bottrop | North Rhine-Westphalia | 46236 | Germany |
| Universitätsfrauenklinik Düsseldorf | Recruiting | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Kliniken Essen-Mitte | Completed | Essen | North Rhine-Westphalia | 45136 | Germany |
| Completed | Herne | North Rhine-Westphalia | 44623 | Germany |
| Institut für Versorgungsforschung in der Onkologie GbR | Recruiting | Koblenz | North Rhine-Westphalia | 56068 | Germany |
| St. Vincenz-Krankenhaus GmbH | Recruiting | Paderborn | North Rhine-Westphalia | 33098 | Germany |
| Praxis Onkologie und Hämatologie | Completed | Recklinghausen | North Rhine-Westphalia | 45657 | Germany |
| Gesellschaft für Medizinische Studien Würselen | Recruiting | Würselen | North Rhine-Westphalia | 52146 | Germany |
| Schwerpunktpraxis für Hämatologie und Onkologie | Recruiting | Kaiserslautern | Rhineland-Palatinate | 67655 | Germany |
| Institut für Versorgungsforschung | Recruiting | Mayen | Rhineland-Palatinate | 56727 | Germany |
| Klinikum Chemnitz gGmbH | Recruiting | Chemnitz | Saxony | 09116 | Germany |
| Universitätsklinik Dresden | Recruiting | Dresden | Saxony | 01307 | Germany |
| Universitäres Krebszentrum Leipzig | Recruiting | Leipzig | Saxony | 04103 | Germany |
| Kreiskrankenhaus Torgau | Recruiting | Torgau | Saxony | 04860 | Germany |
| Universitätsklinikum Halle (Saale) | Recruiting | Halle | Saxony-Anhalt | 06120 | Germany |
| Klinik für Gynäkologie und Geburtshilfe | Completed | Kiel | Schleswig-Holstein | 24105 | Germany |
| Universitätsklinikum Schleswig-Holstein | Recruiting | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Charité | Completed | Berlin | State of Berlin | 10117 | Germany |
| MediOnko-Institut GbR | Recruiting | Berlin | State of Berlin | 10367 | Germany |
| Klinik für Gynäkologie und Geburtshilfe, Helios Kliniken | Recruiting | Berlin | State of Berlin | 13125 | Germany |
| medius KLINIKEN gGmbH, medius KLINIK Ostfildern-Ruit | Recruiting | Ostfildern | 73760 | Germany |
| Derived |
| 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. |
| 34311211 | 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. |
| 33176725 | 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. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided