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JOURNAL ONKOLOGIE – STUDIE
PRAEGNANT

Praegnant Breast Cancer: Early/Advanced/Metastatic

Rekrutierend

NCT-Nummer:
NCT02338167

Studienbeginn:
Juni 2014

Letztes Update:
05.02.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Tuebingen

Collaborator:
-

Studienleiter

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
Hans Tesch, Prof. Dr.
Principal Investigator
Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
Andreas Schneeweiss, Prof. Dr.
Principal Investigator
Nationales Centrum für Tumorerkrankungen (NCT) Sektion Gynäkologische Onkologie

Kontakt

Studienlocations
(3 von 59)

Klinikum Sindelfingen-Böblingen gGmbH
71032 Böblingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Klinik für Frauenheilkunde, Universitätsklinikum Freiburg
79106 Freiburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Hauttumorzentrum der Universitäts-Hautklinik und des NCT Heidelberg
Im Neuenheimer Feld 460
69120 Heidelberg
(Baden-Württemberg)
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Frauenklinik der St. Vincentius-Kliniken gAG
76135 Karlsruhe
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Praxisklinik am Rosengarten
68165 Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
medius Klinik Nürtingen
72622 Nürtingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Paracelsus Krankenhaus Ruit
73760 Ruit
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitätsfrauenklinik Tübingen
Tübingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Interdisziplinäres Brustzentrum der Universitätsfrauenklinik Ulm
Prittwitzstraße 43
89075 Ulm
(Baden-Württemberg)
DeutschlandRekrutierend» Google-Maps
St. Vincentius-Kliniken gAG
76135 Karlsruhe
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
63739 Aschaffenburg
(Bayern)
GermanyRekrutierend» Google-Maps
Hämatologische-onkologische Praxis
86150 Augsburg
(Bayern)
GermanyRekrutierend» Google-Maps
Darmzentrum Klinikum Augsburg
Stenglinstraße 2
86156 Augsburg
DeutschlandRekrutierend» Google-Maps
Sozialstiftung Bamberg Klinikum am Bruderwald
96049 Bamberg
(Bayern)
GermanyRekrutierend» Google-Maps
Brustzentrum Klinikum Bayreuth
Preuschwitzer Straße 101
95445 Bayreuth
DeutschlandRekrutierend» Google-Maps
Gynäkologisches Krebszentrum des DONAUISAR Klinikums Deggendorf
Perlasberger Straße 41
94469 Deggendorf
DeutschlandRekrutierend» Google-Maps
Onkologisches Zentrum Donauwörth
86609 Donauwörth
(Bayern)
GermanyRekrutierend» Google-Maps
Rottal-Inn-Kliniken GmbH
84307 Eggenfelden
(Bayern)
GermanyRekrutierend» Google-Maps
Universitätsfrauenklinik Erlangen
91012 Erlangen
(Bayern)
GermanyRekrutierend» Google-Maps
Brustzentrum Klinikum Fürth
Jakob-Henle-Straße 1
90766 Fürth
DeutschlandRekrutierend» Google-Maps
Klinikum der Universität München Frauenklinik
80337 München
(Bayern)
GermanyRekrutierend» Google-Maps
Frauenklinik und Poliklinik der Technischen Universität München
81675 München
(Bayern)
GermanyRekrutierend» Google-Maps
Caritas-Krankenhaus St. Josef
93053 Regensburg
(Bayern)
GermanyRekrutierend» Google-Maps
Gesundheitszentrum St. Marien GmbH
92224 Amberg
(Bayern)
GermanyRekrutierend» Google-Maps
Praxis für Frauenheilkunde und Geburtshilfe
015517 Fürstenwalde
(Brandenburg)
GermanyRekrutierend» Google-Maps
Ruppiner Kliniken GmbH, Hochschulklinikum der Med. Hochschule Brandenburg
16816 Neuruppin
(Brandenburg)
GermanyRekrutierend» Google-Maps
Christian-Albrechts-Universität Kiel
24105 Kiel
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Klinikum Darmstadt Frauenklinik
64283 Darmstadt
(Hessen)
GermanyRekrutierend» Google-Maps
Centrum für Hämatologie und Onkologie Bethanien
60389 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
Gemeinschaftspraxis für Hämatologie und Onkologie
63225 Langen
(Hessen)
GermanyRekrutierend» Google-Maps
Lahn-Dill-Kliniken GmbH Klinikum Wetzlar
35578 Wetzlar
(Hessen)
GermanyRekrutierend» Google-Maps
g.SUND Gynäkologie Kompetenzzentrum Stralsund
18435 Stralsund
(Mecklenburg-Vorpommern)
GermanyRekrutierend» Google-Maps
Niels-Stensen-Kliniken
49124 Georgsmarienhütte
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Onkologische Schwerpunktpraxis Leer-Emden
26789 Leer
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Leberkarzinomzentrum an der Uniklinik RWTH Aachen
Pauwelsstraße 30
52074 Aachen
(Nordrhein-Westfalen)
DeutschlandRekrutierend» Google-Maps
Gynäkologie und Geburtshilfe im medizinischen Zentrum Bonn
53111 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Brustzentrum Stuttgart am Marienhospital
Böheimstraße 37
70199 Stuttgart
DeutschlandRekrutierend» Google-Maps
Universitätsfrauenklinik Düsseldorf
40225 Düsseldorf
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Interdisziplinäres Brustkrebszentrum Kliniken Essen-Mitte
Henricistraße 92
45136 Essen
(Nordrhein-Westfalen)
DeutschlandRekrutierend» Google-Maps
Institut für Versorgungsforschung in der Onkologie GbR
56068 Koblenz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
St. Vincenz-Krankenhaus GmbH
33098 Paderborn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Praxis Onkologie und Hämatologie
45657 Recklinghausen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Gesellschaft für Medizinische Studien Würselen
52146 Würselen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Schwerpunktpraxis für Hämatologie und Onkologie
67655 Kaiserslautern
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Institut für Versorgungsforschung
56727 Mayen
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Halle (Saale)
06120 Halle
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Klinikum Chemnitz gGmbH
09116 Chemnitz
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitätsklinik Dresden
01307 Dresden
(Sachsen)
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Universitäres Krebszentrum Leipzig
Liebigstraße 20
4103 Leipzig
DeutschlandRekrutierend» Google-Maps
Kreiskrankenhaus Torgau
04860 Torgau
(Sachsen)
GermanyRekrutierend» Google-Maps
Klinik für Gynäkologie und Geburtshilfe
24105 Kiel
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Darmkrebszentrum am Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Ratzeburger Allee 160
23562 Lübeck
DeutschlandRekrutierend» Google-Maps
Interdisziplinäres Brustzentrum der Charité im Charité Comprehensive Cancer Center
Virchowweg 23
10117 Berlin
(Berlin)
DeutschlandRekrutierend» Google-Maps
Klinik für Gynäkologie und Geburtshilfe, Helios Kliniken
13125 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Brustzentrum am Universitätsklinikum Hamburg-Eppendorf
Martinistraße 52
20251 Hamburg
DeutschlandRekrutierend» Google-Maps
Onkologie Lerchenfeld
22081 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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 diagnosis not 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, 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)

Exclusion Criteria:

- 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

Studien-Rationale

Primary outcome:

1. 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.

2. 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

Secondary outcome:

1. 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.):
OS is defined as the time to death from the date of the last progression before or at study entry.

2. 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.):
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.

3. MBC: Objective response (Time Frame - up to 60 months):
Objective response is defined as the best-documented response to the therapy started at study entry or the last therapy started before study entry.

4. MBC: Description of therapies used in the metastatic setting (Time Frame - after 60 months (after study completion)):
Therapies will be categorized and descriptive statistics will be presented.

5. 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):
Assessed with EORTC QlQ-C30 and Visual Analog Scala

6. MBC: Therapy adherence (Time Frame - up to 60 months):
Defined as the percentage of patients in which treat-ments which are terminated as per patients' wish or because of treatment related side effect.

7. 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):
Depression will be assessed by patient reported questionnaires e.g. CESD-R.

8. MBC: Incidence of adverse events, serious adverse events will be reported. (Time Frame - up to 60 months):
According to NCI Common Toxicity Criteria Version 4.03.

9. 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):
Number of patients who will receive molecular testing results compared to the total number of included patients.

10. MBC: Feasibility and satisfaction regarding receipt of molecular testing results (including hereditary genetic alterations) (Time Frame - Once at end of study):
Assessed with a physician and patient questionnaire and documentation of possible confirmatory testing for changes in therapy or eligibility for interventional clinical trial screening.

11. 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):
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.

12. 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):
Patient reported adherence for orally administered therapies will be assessed with suitable questionnaires.

13. EBC: Assessment of distant disease-free survival (DDFS) (Time Frame - Up to 60 months):
DDFS defined as the time to the first distant disease recurrence after study inclusion from time of primary diagnosis before or at study entry.

14. 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):
Assessed with EORTC QLQ C-30 (Version 3.0), EORTC QLQ-BR23 and the EQ-Visual Analog Scale (VAS)

15. 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.):
OS is defined as the time to death from the date of the primary diagnosis before or at study entry.

16. 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.):
BCSS is defined as the time to death due to breast cancer from the date of the primary diagnosis before or at study entry.

17. EBC: Description of therapies used in the early breast cancer setting (Time Frame - after 60 months (after study completion)):
Therapies will be categorized, and descriptive statistics will be presented.

18. 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):
Number of patients who will receive molecular testing results compared to the total number of included pa-tients.

19. EBC: Feasibility and satisfaction regarding receipt of molecular testing results (including hereditary genetic alterations) (Time Frame - Once at end of study):
Assessed with a physician and patient questionnaire and documentation of possible confirmatory testing for changes in therapy or eligibility for interventional clinical trial screening.

20. EBC: Therapy adherence (Time Frame - up to 60 months):
Defined as the percentage of patients in which treat-ments which are terminated as per patients' wish or because of treatment related side effect

21. EBC: Health economics for women with breast cancer (Time Frame - up to 60 months):
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.

22. 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):
Depression will be assessed by patient reported ques-tionnaires e.g. CESD-R.

23. 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):
Patient reported adherence for orally administered therapies will be assessed with suitable questionnaires.

24. EBC: Incidence of adverse events, serious ad-verse events will be reported. (Time Frame - up to 60 months):
NCI Common Toxicity Criteria Version 4.03.

Studien-Arme

  • 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.

Geprüfte Regime

  • Blood sampling:
    A blood sample will be taken during a routine blood draw

Quelle: ClinicalTrials.gov


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