Advanced/Metastatic Breast CancerPRAEGNANTNCT02338167
Praegnant Breast Cancer: Early/Advanced/Metastatic
An observational study of Advanced/Metastatic Breast Cancer and Breast Cancer (Early Breast Cancer), run by University Hospital Tuebingen at 61 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Advanced/Metastatic Breast Cancer, Breast Cancer (Early Breast Cancer)
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 13,500 participants
- Where
- 61 sitesGermany
- Study dates
- Jun 2014to Jul 2030
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
61 sites in 1 country. Contact the study team or a site near you to ask about taking part.
61 sites in 1 country
Germany61 sites, 52 recruiting
- Recruiting
Uniklinik RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
- Recruiting
Gesundheitszentrum St. Marien GmbH
Amberg, Bavaria, 92224
- Recruiting
Anregiomed gKK Klinikum Ansbach Brustzentrum Westmittelfranken
Ansbach, Bavaria, 91522
- Completed
Hämatologische-onkologische Praxis
Augsburg, Bavaria, 86150
- Recruiting
Klinikum Augsburg
Augsburg, Bavaria, 86156
- Recruiting
Sozialstiftung Bamberg Klinikum am Bruderwald
Bamberg, Bavaria, 96049
- Recruiting
Klinikum Bayreuth
Bayreuth, Bavaria, 95445
- Completed
Charité
Berlin, State of Berlin, 10117
- Recruiting
MediOnko-Institut GbR
Berlin, State of Berlin, 10367
- Recruiting
Klinik für Gynäkologie und Geburtshilfe, Helios Kliniken
Berlin, State of Berlin, 13125
- Recruiting
Klinikum Sindelfingen-Böblingen gGmbH
Böblingen, Baden-Wurttemberg, 71032
- Recruiting
Gynäkologie und Geburtshilfe im medizinischen Zentrum Bonn
Bonn, North Rhine-Westphalia, 53111
- Recruiting
Marienhospital
Bottrop, North Rhine-Westphalia, 46236
- Recruiting
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, 09116
- Recruiting
Klinikum Darmstadt Frauenklinik
Darmstadt, Hesse, 64283
- Recruiting
DONAUISAR Klinikum
Deggendorf, Bavaria, 94469
- Recruiting
Onkologisches Zentrum Donauwörth
Donauwörth, Bavaria, 86609
- Recruiting
Universitätsklinik Dresden
Dresden, Saxony, 01307
- Recruiting
Universitätsfrauenklinik Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
- Recruiting
Rottal-Inn-Kliniken GmbH
Eggenfelden, Bavaria, 84307
- Recruiting
Universitätsfrauenklinik Erlangen
Erlangen, Bavaria, 91012
- Completed
Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, 45136
- Recruiting
Centrum für Hämatologie und Onkologie Bethanien
Frankfurt am Main, Hesse, 60389
- Recruiting
Klinik für Frauenheilkunde, Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
- Recruiting
Praxis für Frauenheilkunde und Geburtshilfe
Fürstenwalde, Brandenburg, 015517
- Recruiting
Klinikum Fürth
Fürth, Bavaria, 90766
- Recruiting
Niels-Stensen-Kliniken
Georgsmarienhütte, Lower Saxony, 49124
- Recruiting
Universitätsklinikum Halle (Saale)
Halle, Saxony-Anhalt, 06120
- Recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
- Completed
Onkologie Lerchenfeld
Hamburg, Free and Hanseatic City of Hamburg, 22081
- Recruiting
NCT Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
- Completed
Study site
Herne, North Rhine-Westphalia, 44623
- Recruiting
MVZ am Klinikum Aschaffenburg - Zweigpraxis für Hämatologie und Onkologie
Hösbach, Bavaria, 63768
- Recruiting
Schwerpunktpraxis für Hämatologie und Onkologie
Kaiserslautern, Rhineland-Palatinate, 67655
- Recruiting
ViDia Christliche Kliniken Karlsruhe
Karlsruhe, Baden-Wurttemberg, 76135
- Recruiting
Klinikum Kassel GmbH
Kassel, Hesse, 34125
- Completed
Klinik für Gynäkologie und Geburtshilfe
Kiel, Schleswig-Holstein, 24105
- Recruiting
Institut für Versorgungsforschung in der Onkologie GbR
Koblenz, North Rhine-Westphalia, 56068
- Recruiting
Gemeinschaftspraxis für Hämatologie und Onkologie
Langen, Hesse, 63225
- Recruiting
Onkologische Schwerpunktpraxis Leer-Emden
Leer, Lower Saxony, 26789
- Recruiting
Universitäres Krebszentrum Leipzig
Leipzig, Saxony, 04103
- Recruiting
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
- Recruiting
Praxisklinik am Rosengarten
Mannheim, Baden-Wurttemberg, 68165
- Recruiting
Institut für Versorgungsforschung
Mayen, Rhineland-Palatinate, 56727
- Completed
Onkologie Elisenhof, München
München, Bavaria, 80335
- Recruiting
Klinikum der Universität München Frauenklinik
München, Bavaria, 81337
- Recruiting
Frauenklinik und Poliklinik der Technischen Universität München
München, Bavaria, 81675
- Recruiting
Ruppiner Kliniken GmbH, Hochschulklinikum der Med. Hochschule Brandenburg
Neuruppin, Brandenburg, 16816
- Recruiting
medius Klinik Nürtingen
Nürtingen, Baden-Wurttemberg, 72622
- Recruiting
medius KLINIKEN gGmbH, medius KLINIK Ostfildern-Ruit
Ostfildern, 73760
- Recruiting
St. Vincenz-Krankenhaus GmbH
Paderborn, North Rhine-Westphalia, 33098
- Completed
Praxis Onkologie und Hämatologie
Recklinghausen, North Rhine-Westphalia, 45657
- Recruiting
Caritas-Krankenhaus St. Josef
Regensburg, Bavaria, 93053
- Recruiting
Immanuel Klinik und Poliklinik Rüdersdorf GmbH
Rüdersdorf, Brandenburg, 15562
- Recruiting
g.SUND Gynäkologie Kompetenzzentrum Stralsund
Stralsund, Mecklenburg-Vorpommern, 18435
- Recruiting
Kreiskrankenhaus Torgau
Torgau, Saxony, 04860
- Recruiting
Universitätsfrauenklinik Tübingen
Tübingen, Baden-Wurttemberg
- Recruiting
Universitätsfrauenklinik Ulm
Ulm, Baden-Wurttemberg, 89081
- Completed
Lahn-Dill-Kliniken GmbH Klinikum Wetzlar
Wetzlar, Hesse, 35578
- Recruiting
Gesellschaft für Medizinische Studien Würselen
Würselen, North Rhine-Westphalia, 52146
- Recruiting
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080
About this study
Official title: Prospective Academic Translational Research Network for the Optimization of the Oncological Health Care Quality in the Adjuvant and Advanced/Metastatic Setting: Health Care Research, Pharmacogenomics, Biomarkers, Health Economics
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.
Read more
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.
- Being tested
- Blood sampling
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
A blood sample will be taken during a routine blood draw
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: up to 60 months
MBC: Description of therapies used in the metastatic setting
Therapies will be categorized and descriptive statistics will be presented.
Measured: after 60 months (after study completion)
MBC: Quality of life
Assessed with EORTC QlQ-C30 and Visual Analog Scala
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJun 2014
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Advanced/Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 13,500 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diethelm Wallwiener, Prof. Dr., Principal investigator, Universitätsfrauenklinik TübingenPeter Fasching, Prof. Dr., Principal investigator, Frauenklinik des Universitätsklinikums ErlangenSara Brucker, Prof. Dr., Principal investigator, Universitätsfrauenklinik TübingenHans Tesch, Prof. Dr., Principal investigator, Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus FrankfurtAndreas Schneeweiss, Prof. Dr., Principal investigator, Nationales Centrum für Tumorerkrankungen (NCT) Sektion Gynäkologische Onkologie Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338167
- Sponsor's protocol ID
- SEN-01/14
- Acronym
- PRAEGNANT
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2015
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 41925922Muller 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.
PubMed 35728342Hein 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.
PubMed 34311211Huebner 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.
PubMed 33176725
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Academic Translational Research Network for the Optimization of the Oncological Health Care Quality in the Adjuvant and Advanced/Metastatic Setting: Health Care Research, Pharmacogenomics, Biomarkers, Health Economics
- ClinicalTrials.gov ID
- NCT02338167
- Acronym / sponsor ID
- PRAEGNANT / SEN-01/14
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 13,500 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 60 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced/metastatic breast cancer | – | Procedure: Blood sampling3,500 patients with locally advanced, inoperable/metastatic breast cancer in any line of treatment (e.g. 1st, 2nd, 3rd, or ≥ 4th line). |
| Early breast cancer | – | Procedure: Blood sampling10,000 patients with breast cancer in the neoadjuvant and adjuvant (early breast cancer) setting independent of treatment regimen. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingA blood sample will be taken during a routine blood draw | Procedure or surgery | Advanced/metastatic breast cancer, Early breast cancer |
Primary outcome
MBC (Metastatic Breast Cancer): Discovery of biomarkers, which predict progression free survival (PFS)
Time frame: PFS defined as the time to the first progression after study inclusion from the last time of progression before or at study entry
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.
EBC (Early Breast Cancer): Assessment of disease free sur-vival (DFS)
Time frame: up to 60 months
DFS defined as the time to the first disease recurrence after study inclusion from time of primary diagnosis before or at study entry
24 secondary outcomes
MBC: Assessment of overall survival (OS)
Time frame: 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 frame: Time to death from the date of the last progression before or at study entry.
MBC: Objective response
Time frame: up to 60 months
MBC: Description of therapies used in the metastatic setting
Time frame: after 60 months (after study completion)
MBC: Quality of life
Time frame: 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
Time frame: up to 60 months
MBC: Influencing Factors of Depression in patients with metastatic breast cancer
Time frame: 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.
Time frame: 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.
Time frame: Once at end of study
MBC: Feasibility and satisfaction regarding receipt of molecular testing results (including hereditary genetic alterations)
Time frame: Once at end of study
MBC: Health economics for women with metastatic and/or locally advanced, inoperable breast cancer.
Time frame: 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.
Time frame: 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)
Time frame: Up to 60 months
EBC: Quality of life
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: Once at end of study
EBC: Feasibility and satisfaction regarding receipt of molecular testing results (including hereditary genetic alterations)
Time frame: Once at end of study
EBC: Therapy adherence
Time frame: up to 60 months
EBC: Health economics for women with breast cancer
Time frame: up to 60 months
EBC: Influencing Factors of Depression in patients with breast cancer
Time frame: 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.
Time frame: 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.
Time frame: up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 41925922Horner 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.
- Derived from this study: PubMed 35728342Muller 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.
- Derived from this study: PubMed 34311211Hein 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.
- Derived from this study: PubMed 33176725Huebner 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.
- Biomarkers in Patients with Metastatic Breast Cancer and the PRAEGNANT Study NetworkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diethelm Wallwiener, Prof. Dr. principal investigator
Universitätsfrauenklinik Tübingen
Peter Fasching, Prof. Dr. principal investigator
Frauenklinik des Universitätsklinikums Erlangen
Sara Brucker, Prof. Dr. principal investigator
Universitätsfrauenklinik Tübingen
61 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced/Metastatic Breast Cancer and Breast Cancer (Early Breast Cancer), run by University Hospital Tuebingen at 61 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erik Belleville, PhD (+49 931 359200 ext. 36, belleville@clin-sol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MBC (Metastatic Breast Cancer): Discovery of biomarkers, which predict progression free survival (PFS) (time frame: PFS defined as the time to the first progression after study inclusion from the last time of progression before or at study entry). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02338167, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.