Alpelisib and Fulvestrant in PIK3CA-mutated hormone receptor-positive HER2-negative advanced breast cancer included in the German PRAEGNANT trial.
Manuel Hörner, Lara M Tretschock, Nelson John...
https://pubmed.ncbi.nlm.nih.gov/41925922Actively Recruiting
Age: 18Years - 99Years
All Genders
ID02338167
Prospective Academic Translational Research Network for Optimizing Oncological Health Care Quality in Early and Advanced/Metastatic Breast Cancer
Led by University Hospital Tuebingen · Updated on 2026-01-30
13500
Participants Needed
61
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with breast cancer, focusing on those with metastatic disease who typically have the poorest outlook. The trial aims to improve treatment decisions and quality of care by analyzing tumor characteristics. Although national guidelines recommend molecular reassessment of metastatic tumors, biopsies are rare due to invasiveness, so the study explores blood-based methods to assess tumor features and their relation to treatment outcomes and health economics. The study involves two groups: about 3,500 patients with locally advanced or metastatic breast cancer receiving any line of treatment, and approximately 10,000 patients with early breast cancer undergoing neoadjuvant or adjuvant therapy regardless of regimen. Blood samples will be collected during routine blood draws to analyze tumor molecular characteristics and biomarkers for progression and survival. Participants will be followed with assessments including quality of life, therapy adherence, depression factors, and adverse events at study entry and regularly up to 60 months. The study will measure progression-free survival in metastatic breast cancer and disease-free survival in early breast cancer, along with overall survival and health economic outcomes. Results of molecular testing will be shared with patients at study end, providing comprehensive data to support improved breast cancer care.
CONDITIONS
Brief Title
Praegnant Breast Cancer: Early/Advanced/Metastatic
Who Can Participate
Age: 18Years - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adult breast cancer patients aged 18 years or older
- Patients with breast cancer and no distant metastases diagnosed within 91 days before study entry (early breast cancer group)
- Patients with invasive breast cancer aged 18 years or older (advanced/metastatic group)
- Patients with metastatic or locally advanced, inoperable breast cancer confirmed by clinical imaging
- Patients willing and able to sign the informed consent form
You will not qualify if you...
- Patients who did not sign the informed consent form
- Patients not eligible for observation due to lack of availability or severe comorbidities as judged by the treating physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 60 months
Participants with breast cancer are observed over time with blood samples taken during routine blood draws to assess disease progression, therapy adherence, quality of life, and other health factors.
Visits every 3 months or following a change in therapy until Month 24; every 6 months from Month 24 until death or withdrawal of consent
Long-term Monitoring
Duration - Until study completion at 2030-07
Participants continue to be observed after the initial monitoring period for survival outcomes and receipt of molecular testing results.
1 visit at study end for molecular test results
Trial Site Locations
Total: 61 locations
1
Klinikum Sindelfingen-Böblingen gGmbH
Böblingen, Baden-Wurttemberg, Germany, 71032
Actively Recruiting
2
Klinik für Frauenheilkunde, Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
3
NCT Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
4
ViDia Christliche Kliniken Karlsruhe
Karlsruhe, Baden-Wurttemberg, Germany, 76135
Actively Recruiting
5
Praxisklinik am Rosengarten
Mannheim, Baden-Wurttemberg, Germany, 68165
Actively Recruiting
6
medius Klinik Nürtingen
Nürtingen, Baden-Wurttemberg, Germany, 72622
Actively Recruiting
7
Universitätsfrauenklinik Tübingen
Tübingen, Baden-Wurttemberg, Germany
Actively Recruiting
8
Universitätsfrauenklinik Ulm
Ulm, Baden-Wurttemberg, Germany, 89081
Actively Recruiting
9
Gesundheitszentrum St. Marien GmbH
Amberg, Bavaria, Germany, 92224
Actively Recruiting
10
Anregiomed gKK Klinikum Ansbach Brustzentrum Westmittelfranken
Ansbach, Bavaria, Germany, 91522
Actively Recruiting
11
Hämatologische-onkologische Praxis
Augsburg, Bavaria, Germany, 86150
Completed
12
Klinikum Augsburg
Augsburg, Bavaria, Germany, 86156
Actively Recruiting
13
Sozialstiftung Bamberg Klinikum am Bruderwald
Bamberg, Bavaria, Germany, 96049
Actively Recruiting
14
Klinikum Bayreuth
Bayreuth, Bavaria, Germany, 95445
Actively Recruiting
15
DONAUISAR Klinikum
Deggendorf, Bavaria, Germany, 94469
Actively Recruiting
16
Onkologisches Zentrum Donauwörth
Donauwörth, Bavaria, Germany, 86609
Actively Recruiting
17
Rottal-Inn-Kliniken GmbH
Eggenfelden, Bavaria, Germany, 84307
Actively Recruiting
18
Universitätsfrauenklinik Erlangen
Erlangen, Bavaria, Germany, 91012
Actively Recruiting
19
Klinikum Fürth
Fürth, Bavaria, Germany, 90766
Actively Recruiting
20
MVZ am Klinikum Aschaffenburg - Zweigpraxis für Hämatologie und Onkologie
Hösbach, Bavaria, Germany, 63768
Actively Recruiting
21
Onkologie Elisenhof, München
München, Bavaria, Germany, 80335
Completed
22
Klinikum der Universität München Frauenklinik
München, Bavaria, Germany, 81337
Actively Recruiting
23
Frauenklinik und Poliklinik der Technischen Universität München
München, Bavaria, Germany, 81675
Actively Recruiting
24
Caritas-Krankenhaus St. Josef
Regensburg, Bavaria, Germany, 93053
Actively Recruiting
25
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
26
Praxis für Frauenheilkunde und Geburtshilfe
Fürstenwalde, Brandenburg, Germany, 015517
Actively Recruiting
27
Ruppiner Kliniken GmbH, Hochschulklinikum der Med. Hochschule Brandenburg
Neuruppin, Brandenburg, Germany, 16816
Actively Recruiting
28
Immanuel Klinik und Poliklinik Rüdersdorf GmbH
Rüdersdorf, Brandenburg, Germany, 15562
Actively Recruiting
29
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
Actively Recruiting
30
Onkologie Lerchenfeld
Hamburg, Free and Hanseatic City of Hamburg, Germany, 22081
Completed
31
Klinikum Darmstadt Frauenklinik
Darmstadt, Hesse, Germany, 64283
Actively Recruiting
32
Centrum für Hämatologie und Onkologie Bethanien
Frankfurt am Main, Hesse, Germany, 60389
Actively Recruiting
33
Klinikum Kassel GmbH
Kassel, Hesse, Germany, 34125
Actively Recruiting
34
Gemeinschaftspraxis für Hämatologie und Onkologie
Langen, Hesse, Germany, 63225
Actively Recruiting
35
Lahn-Dill-Kliniken GmbH Klinikum Wetzlar
Wetzlar, Hesse, Germany, 35578
Completed
36
Niels-Stensen-Kliniken
Georgsmarienhütte, Lower Saxony, Germany, 49124
Actively Recruiting
37
Onkologische Schwerpunktpraxis Leer-Emden
Leer, Lower Saxony, Germany, 26789
Actively Recruiting
38
g.SUND Gynäkologie Kompetenzzentrum Stralsund
Stralsund, Mecklenburg-Vorpommern, Germany, 18435
Actively Recruiting
39
Uniklinik RWTH Aachen
Aachen, North Rhine-Westphalia, Germany, 52074
Actively Recruiting
40
Gynäkologie und Geburtshilfe im medizinischen Zentrum Bonn
Bonn, North Rhine-Westphalia, Germany, 53111
Actively Recruiting
41
Marienhospital
Bottrop, North Rhine-Westphalia, Germany, 46236
Actively Recruiting
42
Universitätsfrauenklinik Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Actively Recruiting
43
Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, Germany, 45136
Completed
44
Herne, North Rhine-Westphalia, Germany, 44623
Completed
45
Institut für Versorgungsforschung in der Onkologie GbR
Koblenz, North Rhine-Westphalia, Germany, 56068
Actively Recruiting
46
St. Vincenz-Krankenhaus GmbH
Paderborn, North Rhine-Westphalia, Germany, 33098
Actively Recruiting
47
Praxis Onkologie und Hämatologie
Recklinghausen, North Rhine-Westphalia, Germany, 45657
Completed
48
Gesellschaft für Medizinische Studien Würselen
Würselen, North Rhine-Westphalia, Germany, 52146
Actively Recruiting
49
Schwerpunktpraxis für Hämatologie und Onkologie
Kaiserslautern, Rhineland-Palatinate, Germany, 67655
Actively Recruiting
50
Institut für Versorgungsforschung
Mayen, Rhineland-Palatinate, Germany, 56727
Actively Recruiting
51
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany, 09116
Actively Recruiting
52
Universitätsklinik Dresden
Dresden, Saxony, Germany, 01307
Actively Recruiting
53
Universitäres Krebszentrum Leipzig
Leipzig, Saxony, Germany, 04103
Actively Recruiting
54
Kreiskrankenhaus Torgau
Torgau, Saxony, Germany, 04860
Actively Recruiting
55
Universitätsklinikum Halle (Saale)
Halle, Saxony-Anhalt, Germany, 06120
Actively Recruiting
56
Klinik für Gynäkologie und Geburtshilfe
Kiel, Schleswig-Holstein, Germany, 24105
Completed
57
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany, 23538
Actively Recruiting
58
Charité
Berlin, State of Berlin, Germany, 10117
Completed
59
MediOnko-Institut GbR
Berlin, State of Berlin, Germany, 10367
Actively Recruiting
60
Klinik für Gynäkologie und Geburtshilfe, Helios Kliniken
Berlin, State of Berlin, Germany, 13125
Actively Recruiting
61
medius KLINIKEN gGmbH, medius KLINIK Ostfildern-Ruit
Ostfildern, Germany, 73760
Actively Recruiting
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Research Team
E
Erik Belleville, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
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.
Volkmar Müller, Alexander Hein, Andreas D Hartkopf...
https://pubmed.ncbi.nlm.nih.gov/35728342Prognostic effect of low-level HER2 expression in patients with clinically negative HER2 status.
Alexander Hein, Andreas D Hartkopf, Julius Emons...
https://pubmed.ncbi.nlm.nih.gov/34311211Heregulin (HRG) assessment for clinical trial eligibility testing in a molecular registry (PRAEGNANT) in Germany.
Hanna Huebner, Christian M Kurbacher, Geoffrey Kuesters...
https://pubmed.ncbi.nlm.nih.gov/33176725