Reaching for Evidence-baSed Chemotherapy Use in Endocrine Sensitive Breast Cancer

NCT03503799 | Active Not Recruiting DMC

• 1 other identifier: NOGGO B3
• Study Type: observational
• Target: 1,191
• Locations: 2 countries
• Sites: 40

Brief Summary

Systematic assessment of survival data of patients who have been tested with EndoPredict®; prospective proof that patients with low risk classification by EndoPredict® (EPclin) can safely forgo chemotherapy and be treated with endocrine therapy alone.

Conditions

Estrogen Receptor Positive Tumor; Human Epidermal Growth Factor Receptor 2 Negative Tumor; Primary Invasive Breast Cancer

Keywords

breast cancer; EndoPredict®; endocrine therapy

Outcome Measures

Primary Outcomes (1)

• Distant metastasis free survival

  To show that female patients who have been tested as "low risk" by EndoPredict® (EPclin) and have been treated with endocrine therapy only for at least 5 years have a 10-year distant metastasis-free survival (DMFS) \> 90 % (lower boundary of the one-sided 95 % confidence interval)

  10 years

Secondary Outcomes (30)

• DMFS "low risk"

  3, 5 and 10 years

• DFS "low risk"

  3, 5 and 10 years

• OS "low risk"

  3, 5 and 10 years

• DMFS "high risk"

  3, 5 and 10 years

• DFS "high risk"

  3, 5 and 10 years

Study Arms (1)

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

Other: Observation

Interventions

Observation OTHER

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.

Observational Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary stage I or Ii breast cancer who met all inclusin and no exclusion criteria

You may qualify if:

• Informed consent
• Age ≥ 18 years
• Patients with primary invasive breast cancer, Stage I/II
• ER-positive
• HER2-negative
• N0 or N1 (1-3 positive lymph nodes)
• T1 - T3

You may not qualify if:

• Inflammatory breast cancer
• Bilateral breast cancer
• Breast cancer in the last 10 years
• Other invasive malignancies in the last 5 years

Sponsors & Collaborators

• North Eastern German Society of Gynaecological Oncology: lead
• Coordinating Center for Clinical Trials (KKS; Philipps-University of Marburg, Germany): collaborator

Study Sites (40)

Frauenklinik der Technischen Universität München

München, Bavaria, 81675, Germany

Location

Vivantes Klinikum am Urban

Berlin, State of Berlin, 10967, Germany

Location

ANregiomed Ansbach

Ansbach, 91522, Germany

Location

DRK Kliniken Köpenick

Berlin, 12559, Germany

Location

MVZ Hellersdorf - Zweigstelle Biesdorf

Berlin, 12683, Germany

Location

Park-Klinik Weißensee

Berlin, 13086, Germany

Location

Helios Klinikum Berlin Buch

Berlin, 13125, Germany

Location

Klinikum Bremerhaven Reinkenheide

Bremerhaven, 27574, Germany

Location

Klinikum Chemnitz gGmbH

Chemnitz, 09116, Germany

Location

Krankenhaus St. Joseph Stift Dresden GmbH

Dresden, 01307, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Evangelisches Krankenhaus

Düsseldorf, 40217, Germany

Location

Kreisklinik Ebersberg

Ebersberg, 85560, Germany

Location

Klinikum Erding

Erding, 85435, Germany

Location

Praxis Dr. Heinrich

Fürstenwalde, 15517, Germany

Location

Krankenhaus St. Elisabeth und St. Barbara

Halle, Germany

Location

Krankenhaus Jerusalem

Hamburg, 20357, Germany

Location

Asklepios Klinik Barmbek

Hamburg, 22307, Germany

Location

Mathilden Hospital

Herford, 32052, Germany

Location

Frauenärzte am Bahnhofsplatz

Hildesheim, 31134, Germany

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

Gemeinschaftsklinikum Mittelrhein gGmbH Kemperhof

Koblenz, 56073, Germany

Location

VK & K Studien GbR

Landshut, 84036, Germany

Location

Krankenhaus St. Marienstift

Magdeburg, 39110, Germany

Location

Klinikum Magdeburg gGmbH

Magdeburg, 39130, Germany

Location

Klinikum Fichtelgebirge

Marktredwitz, 95615, Germany

Location

Charité - Universitätsmedizin Berlin

Mitte, 10117, Germany

Location

Gemeinschaftspraxis Gynäkologie Arabella

München, 81925, Germany

Location

Oberhavel Kliniken GmbH

Oranienburg, 16515, Germany

Location

Regioklinik Pinneberg

Pinneberg, 25421, Germany

Location

Ernst von Bergmann Klinikum

Potsdam, 14467, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

RoMed Klinikum Rosenheim

Rosenheim, 83022, Germany

Location

Klinikum Traunstein

Traunstein, 83278, Germany

Location

Klinikum Mutterhaus der Borromäerinnen gGmbH

Trier, 54290, Germany

Location

Harzklinikum Dorothea Christiane Erxleben

Wernigerode, 38855, Germany

Location

Helios Universitätsklinikum Wuppertal

Wuppertal, 42283, Germany

Location

Brustzentrum Bern Lindenhofgruppe

Bern, 3012, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

Spital Zollikerberg

Zurich, Switzerland

Location

Related Publications (15)

• Buus R, Sestak I, Kronenwett R, Denkert C, Dubsky P, Krappmann K, Scheer M, Petry C, Cuzick J, Dowsett M. Comparison of EndoPredict and EPclin With Oncotype DX Recurrence Score for Prediction of Risk of Distant Recurrence After Endocrine Therapy. J Natl Cancer Inst. 2016 Jul 10;108(11):djw149. doi: 10.1093/jnci/djw149. Print 2016 Nov.

  BACKGROUND

• 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.

  PMID: 25929335 BACKGROUND

• Denkert C, Kronenwett R, Schlake W, Bohmann K, Penzel R, Weber KE, Hofler H, Lehmann U, Schirmacher P, Specht K, Rudas M, Kreipe HH, Schraml P, Schlake G, Bago-Horvath Z, Tiecke F, Varga Z, Moch H, Schmidt M, Prinzler J, Kerjaschki D, Sinn BV, Muller BM, Filipits M, Petry C, Dietel M. Decentral gene expression analysis for ER+/Her2- breast cancer: results of a proficiency testing program for the EndoPredict assay. Virchows Arch. 2012 Mar;460(3):251-9. doi: 10.1007/s00428-012-1204-4. Epub 2012 Feb 28.

  BACKGROUND

• 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.

  PMID: 25836324 BACKGROUND

• 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.

  PMID: 24157828 BACKGROUND

• 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.

  PMID: 23035151 BACKGROUND

• 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.

  PMID: 22152853 BACKGROUND

• 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.

  PMID: 28877230 BACKGROUND

• 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.

  PMID: 21807638 BACKGROUND

• 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.

  PMID: 25867274 BACKGROUND

• 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.

  PMID: 23039280 BACKGROUND

• 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.

  PMID: 24725534 BACKGROUND

• 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.

  PMID: 22447922 BACKGROUND

• 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.

  PMID: 23826382 BACKGROUND

• 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.

  PMID: 25218890 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Marion Kiechle, Prof. Dr.

  TU München (TUM) Lehrstuhl für Gynäkologie und Geburtshilfe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 20, 2018
• Study Start: July 17, 2018
• Primary Completion (Estimated): October 1, 2032
• Study Completion (Estimated): October 1, 2032
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3); DE (37)