Reaching for Evidence-baSed Chemotherapy Use in Endocrine Sensitive Breast Cancer
NCT ID: NCT03503799
Last Updated: 2024-11-15
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
1191 participants
OBSERVATIONAL
2018-07-17
2032-10-01
Brief Summary
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Detailed Description
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The study is organized and managed by the NOGGO e.V. (North Eastern German Society of Gynaecological Oncology e.V.) study coordination office under the existing and efficient infrastructure. All patients who receive gene expression analysis with EndoPredict® and satisfy the remaining inclusion / exclusion criteria may participate in the study. Data collection is prospective and non-interventional. The recruitment of the required patients is expected to take a maximum of 36 months .
It must be emphasized that the study is data collection only and not an interventional study. This means that the choice and implementation of the therapy as well as the treatment assessments and frequency during and after the treatment can only be determined by the Investigator.
The decision to participate in the study is independent of the patient´s therapy within the framework of a study. Patient data will be recorded at the time of inclusion and once a year thereafter. Patient follow-up will be by phone from the second year onward.
Primary objective is to show that female patients who have been tested as "low risk" by EPclin and have been treated with endocrine therapy only for at least 5 years have a 10-year DMFS rate \> 90% (lower boundary of the one-sided 95% confidence interval).
Secondary objectives comprise the evaluation of DMFS (distant metastasis free survival) , DFS (disease free survival) and OS (overall survival) rates at different time points and for different groups. Assessment of the given chemotherapy regimens and the given endocrine therapy will be performed and the proportions of patients will be determined with respect to the received treatment and its duration in different groups. Furthermore, the proportion of patients in whom the tumor board recommendation follows the EndoPredict® result and the proportion of patients actually treated according to EndoPredict® result will be determined.
The association between outcome and treatment, EPclin, EP, and classical prognostic factors will be investigated in different groups of patients. The correlation and concordance between EPclin calculations derived from biopsies and surgical specimens will be assessed.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Observational Group
Patients with primary invasive breast cancer, Stage I/II; ER positive, HER2 (human epidermal growth factor receptor 2) negative, N0-N1, T1-T3, tested with EndoPredict®, age over 18 years, informed consent
Observation
Visit 1 Informed consent Medical history Demographics Result of EndoPredict® Test Status of menopause Disease status Tumor board decision Planned anti-tumor-therapy
Visit 2, 1 year after inclusion This visit will be documented at the study site Status of menopause Disease status Anti-tumor therapy Survival
Following visits For these visits, patients will be asked directly through the Center for Clinical Trials of the Philipps-University Marburg (KKS Marburg) via phone.
Status of Menopause Disease status Anti-tumor therapy Survival
Treatment after end of the study The patient will be treated during and after end of study by physician's choice.
Interventions
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Observation
Visit 1 Informed consent Medical history Demographics Result of EndoPredict® Test Status of menopause Disease status Tumor board decision Planned anti-tumor-therapy
Visit 2, 1 year after inclusion This visit will be documented at the study site Status of menopause Disease status Anti-tumor therapy Survival
Following visits For these visits, patients will be asked directly through the Center for Clinical Trials of the Philipps-University Marburg (KKS Marburg) via phone.
Status of Menopause Disease status Anti-tumor therapy Survival
Treatment after end of the study The patient will be treated during and after end of study by physician's choice.
Eligibility Criteria
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Inclusion Criteria
2. Tested with EndoPredict within the previous 6 months before inclusion
3. Age ≥ 18 years
4. Patients with primary invasive breast cancer, Stage I/II
5. ER-positive
6. HER2-negative
7. N0 or N1 (1-3 positive lymph nodes)
8. T1 - T3
Exclusion Criteria
2. Bilateral breast cancer
3. Breast cancer in the last 10 years
4. Other invasive malignancies in the last 5 years
18 Years
ALL
No
Sponsors
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Center for Clinical Trials Philipps University Marburg
UNKNOWN
North Eastern German Society of Gynaecological Oncology
OTHER
Responsible Party
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Principal Investigators
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Marion Kiechle, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
TU München (TUM) Lehrstuhl für Gynäkologie und Geburtshilfe
Locations
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Frauenklinik der Technischen Universität München
München, Bavaria, Germany
Vivantes Klinikum am Urban
Berlin, State of Berlin, Germany
ANregiomed Ansbach
Ansbach, , Germany
DRK Kliniken Köpenick
Berlin, , Germany
MVZ Hellersdorf - Zweigstelle Biesdorf
Berlin, , Germany
Park-Klinik Weißensee
Berlin, , Germany
Helios Klinikum Berlin Buch
Berlin, , Germany
Klinikum Bremerhaven Reinkenheide
Bremerhaven, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Krankenhaus St. Joseph Stift Dresden GmbH
Dresden, , Germany
Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Evangelisches Krankenhaus
Düsseldorf, , Germany
Kreisklinik Ebersberg
Ebersberg, , Germany
Klinikum Erding
Erding, , Germany
Praxis Dr. Heinrich
Fürstenwalde, , Germany
Krankenhaus St. Elisabeth und St. Barbara
Halle, , Germany
Krankenhaus Jerusalem
Hamburg, , Germany
Asklepios Klinik Barmbek
Hamburg, , Germany
Mathilden Hospital
Herford, , Germany
Frauenärzte am Bahnhofsplatz
Hildesheim, , Germany
Universitätsklinikum Jena
Jena, , Germany
Gemeinschaftsklinikum Mittelrhein gGmbH Kemperhof
Koblenz, , Germany
VK & K Studien GbR
Landshut, , Germany
Krankenhaus St. Marienstift
Magdeburg, , Germany
Klinikum Magdeburg gGmbH
Magdeburg, , Germany
Klinikum Fichtelgebirge
Marktredwitz, , Germany
Charité - Universitätsmedizin Berlin
Mitte, , Germany
Gemeinschaftspraxis Gynäkologie Arabella
München, , Germany
Oberhavel Kliniken GmbH
Oranienburg, , Germany
Regioklinik Pinneberg
Pinneberg, , Germany
Ernst von Bergmann Klinikum
Potsdam, , Germany
Universitätsklinikum Regensburg
Regensburg, , Germany
RoMed Klinikum Rosenheim
Rosenheim, , Germany
Klinikum Traunstein
Traunstein, , Germany
Klinikum Mutterhaus der Borromäerinnen gGmbH
Trier, , Germany
Harzklinikum Dorothea Christiane Erxleben
Wernigerode, , Germany
Helios Universitätsklinikum Wuppertal
Wuppertal, , Germany
Brustzentrum Bern Lindenhofgruppe
Bern, , Switzerland
Luzerner Kantonsspital
Lucerne, , Switzerland
Spital Zollikerberg
Zurich, , Switzerland
Countries
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References
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Georgia Dental Service Corporation opens offices, signs contracts. J Ga Dent Assoc. 1968 Jul;42(1):12-4. No abstract available.
Cobain EF, Hayes DF. Indications for prognostic gene expression profiling in early breast cancer. Curr Treat Options Oncol. 2015 May;16(5):23. doi: 10.1007/s11864-015-0340-x.
Kim OH. Radionuclide detection and differential diagnosis of left-to-right cardiac shunts by analysis of time-activity curves. Osaka City Med J. 1986 Dec;32(2):65-88. No abstract available.
Denkert C, Pfitzner BM, Heppner BI, Dietel M. [Molecular pathology for breast cancer: Importance of the gene expression profile]. Pathologe. 2015 Mar;36(2):145-53. doi: 10.1007/s00292-015-0009-z. German.
Dubsky P, Brase JC, Jakesz R, Rudas M, Singer CF, Greil R, Dietze O, Luisser I, Klug E, Sedivy R, Bachner M, Mayr D, Schmidt M, Gehrmann MC, Petry C, Weber KE, Fisch K, Kronenwett R, Gnant M, Filipits M; Austrian Breast and Colorectal Cancer Study Group (ABCSG). The EndoPredict score provides prognostic information on late distant metastases in ER+/HER2- breast cancer patients. Br J Cancer. 2013 Dec 10;109(12):2959-64. doi: 10.1038/bjc.2013.671. Epub 2013 Oct 24.
Dubsky P, Filipits M, Jakesz R, Rudas M, Singer CF, Greil R, Dietze O, Luisser I, Klug E, Sedivy R, Bachner M, Mayr D, Schmidt M, Gehrmann MC, Petry C, Weber KE, Kronenwett R, Brase JC, Gnant M; Austrian Breast and Colorectal Cancer Study Group (ABCSG). EndoPredict improves the prognostic classification derived from common clinical guidelines in ER-positive, HER2-negative early breast cancer. Ann Oncol. 2013 Mar;24(3):640-7. doi: 10.1093/annonc/mds334. Epub 2012 Oct 3.
Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Peto R, Davies C, Godwin J, Gray R, Pan HC, Clarke M, Cutter D, Darby S, McGale P, Taylor C, Wang YC, Bergh J, Di Leo A, Albain K, Swain S, Piccart M, Pritchard K. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet. 2012 Feb 4;379(9814):432-44. doi: 10.1016/S0140-6736(11)61625-5. Epub 2011 Dec 5.
Ettl J, Klein E, Hapfelmeier A, Grosse Lackmann K, Paepke S, Petry C, Specht K, Wolff L, Hofler H, Kiechle M. Decision impact and feasibility of different ASCO-recommended biomarkers in early breast cancer: Prospective comparison of molecular marker EndoPredict and protein marker uPA/PAI-1. PLoS One. 2017 Sep 6;12(9):e0183917. doi: 10.1371/journal.pone.0183917. eCollection 2017.
Filipits M, Rudas M, Jakesz R, Dubsky P, Fitzal F, Singer CF, Dietze O, Greil R, Jelen A, Sevelda P, Freibauer C, Muller V, Janicke F, Schmidt M, Kolbl H, Rody A, Kaufmann M, Schroth W, Brauch H, Schwab M, Fritz P, Weber KE, Feder IS, Hennig G, Kronenwett R, Gehrmann M, Gnant M; EP Investigators. A new molecular predictor of distant recurrence in ER-positive, HER2-negative breast cancer adds independent information to conventional clinical risk factors. Clin Cancer Res. 2011 Sep 15;17(18):6012-20. doi: 10.1158/1078-0432.CCR-11-0926. Epub 2011 Aug 1.
Fitzal F, Filipits M, Rudas M, Greil R, Dietze O, Samonigg H, Lax S, Herz W, Dubsky P, Bartsch R, Kronenwett R, Gnant M. The genomic expression test EndoPredict is a prognostic tool for identifying risk of local recurrence in postmenopausal endocrine receptor-positive, her2neu-negative breast cancer patients randomised within the prospective ABCSG 8 trial. Br J Cancer. 2015 Apr 14;112(8):1405-10. doi: 10.1038/bjc.2015.98. Epub 2015 Mar 24.
Kronenwett R, Bohmann K, Prinzler J, Sinn BV, Haufe F, Roth C, Averdick M, Ropers T, Windbergs C, Brase JC, Weber KE, Fisch K, Muller BM, Schmidt M, Filipits M, Dubsky P, Petry C, Dietel M, Denkert C. Decentral gene expression analysis: analytical validation of the Endopredict genomic multianalyte breast cancer prognosis test. BMC Cancer. 2012 Oct 5;12:456. doi: 10.1186/1471-2407-12-456.
Martin M, Brase JC, Calvo L, Krappmann K, Ruiz-Borrego M, Fisch K, Ruiz A, Weber KE, Munarriz B, Petry C, Rodriguez CA, Kronenwett R, Crespo C, Alba E, Carrasco E, Casas M, Caballero R, Rodriguez-Lescure A. Clinical validation of the EndoPredict test in node-positive, chemotherapy-treated ER+/HER2- breast cancer patients: results from the GEICAM 9906 trial. Breast Cancer Res. 2014 Apr 12;16(2):R38. doi: 10.1186/bcr3642.
Muller BM, Brase JC, Haufe F, Weber KE, Budzies J, Petry C, Prinzler J, Kronenwett R, Dietel M, Denkert C. Comparison of the RNA-based EndoPredict multigene test between core biopsies and corresponding surgical breast cancer sections. J Clin Pathol. 2012 Jul;65(7):660-2. doi: 10.1136/jclinpath-2012-200716. Epub 2012 Mar 23.
Muller BM, Keil E, Lehmann A, Winzer KJ, Richter-Ehrenstein C, Prinzler J, Bangemann N, Reles A, Stadie S, Schoenegg W, Eucker J, Schmidt M, Lippek F, Johrens K, Pahl S, Sinn BV, Budczies J, Dietel M, Denkert C. The EndoPredict Gene-Expression Assay in Clinical Practice - Performance and Impact on Clinical Decisions. PLoS One. 2013 Jun 27;8(6):e68252. doi: 10.1371/journal.pone.0068252. Print 2013.
Poremba C, Uhlendorff J, Pfitzner BM, Hennig G, Bohmann K, Bojar H, Krenn V, Brase JC, Haufe F, Averdick M, Dietel M, Kronenwett R, Denkert C. Preanalytical variables and performance of diagnostic RNA-based gene expression analysis in breast cancer. Virchows Arch. 2014 Oct;465(4):409-17. doi: 10.1007/s00428-014-1652-0. Epub 2014 Sep 14.
Other Identifiers
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NOGGO B3
Identifier Type: -
Identifier Source: org_study_id
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