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Primary Invasive Breast CancerRESCUENCT03503799

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

An observational study of Primary Invasive Breast Cancer and Estrogen Receptor Positive Tumor, run by North Eastern German Society of Gynaecological Oncology at 40 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Observation
How many people
1,191 participants
Where
40 sitesin 2 countries
Study dates
17 Jul 2018to 1 Oct 2032
How long will I take part?
10 Years
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Informed consent
  • Tested with EndoPredict within the previous 6 months before inclusion
  • 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

Who cannot join

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

Trial locations and contacts

40 sites in 2 countries.

40 sites in 2 countries

Germany37 sites

  • ANregiomed Ansbach

    Ansbach, 91522

  • Vivantes Klinikum am Urban

    Berlin, State of Berlin, 10967

  • DRK Kliniken Köpenick

    Berlin, 12559

  • MVZ Hellersdorf - Zweigstelle Biesdorf

    Berlin, 12683

  • Park-Klinik Weißensee

    Berlin, 13086

  • Helios Klinikum Berlin Buch

    Berlin, 13125

  • Klinikum Bremerhaven Reinkenheide

    Bremerhaven, 27574

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

  • Krankenhaus St. Joseph Stift Dresden GmbH

    Dresden, 01307

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 01307

  • Evangelisches Krankenhaus

    Düsseldorf, 40217

  • Kreisklinik Ebersberg

    Ebersberg, 85560

  • Klinikum Erding

    Erding, 85435

  • Praxis Dr. Heinrich

    Fürstenwalde, 15517

  • Krankenhaus St. Elisabeth und St. Barbara

    Halle

  • Krankenhaus Jerusalem

    Hamburg, 20357

  • Asklepios Klinik Barmbek

    Hamburg, 22307

  • Mathilden Hospital

    Herford, 32052

  • Frauenärzte am Bahnhofsplatz

    Hildesheim, 31134

  • Universitätsklinikum Jena

    Jena, 07747

  • Gemeinschaftsklinikum Mittelrhein gGmbH Kemperhof

    Koblenz, 56073

  • VK & K Studien GbR

    Landshut, 84036

  • Krankenhaus St. Marienstift

    Magdeburg, 39110

  • Klinikum Magdeburg gGmbH

    Magdeburg, 39130

  • Klinikum Fichtelgebirge

    Marktredwitz, 95615

  • Charité - Universitätsmedizin Berlin

    Mitte, 10117

  • Frauenklinik der Technischen Universität München

    München, Bavaria, 81675

  • Gemeinschaftspraxis Gynäkologie Arabella

    München, 81925

  • Oberhavel Kliniken GmbH

    Oranienburg, 16515

  • Regioklinik Pinneberg

    Pinneberg, 25421

  • Ernst von Bergmann Klinikum

    Potsdam, 14467

  • Universitätsklinikum Regensburg

    Regensburg, 93053

  • RoMed Klinikum Rosenheim

    Rosenheim, 83022

  • Klinikum Traunstein

    Traunstein, 83278

  • Klinikum Mutterhaus der Borromäerinnen gGmbH

    Trier, 54290

  • Harzklinikum Dorothea Christiane Erxleben

    Wernigerode, 38855

  • Helios Universitätsklinikum Wuppertal

    Wuppertal, 42283

Other trials in Germany

Switzerland3 sites

  • Brustzentrum Bern Lindenhofgruppe

    Bern, 3012

  • Luzerner Kantonsspital

    Lucerne, 6000

  • Spital Zollikerberg

    Zurich

Other trials in Switzerland

About this study

Official title: Prospective Assessment of Disease Progression in Primary Breast Cancer Patients Undergoing EndoPredict® Gene Expression Testing - a Care Research Study

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.

Read the detailed description

The goal of the study is to receive current and comprehensive information about the diseasefree (remote metastasis free and recurrence free) interval of EndoPredict® low risk patients.

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.

Being tested
Observation
Keywords
breast cancer, EndoPredict®, endocrine therapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationOther

    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.

Study groups in NCT03503799
Study groupRoleWhat they receive
Observational GroupPatients 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
Receives: Other: Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 10 years

Secondary outcomes (30)

  1. DMFS "low risk"

    Assessment of DMFS of patients with EPclin "low risk" (or EP "low risk" [EP score <5] if EPclin cannot be calculated after surgery in the neoadjuvant setting) (in all patients, in the relevant target group and separately in men and women and in pre- and postmenopausal women with regard to treatment).

    Measured: 3, 5 and 10 years

  2. DFS "low risk"

    Assessment of DFS of patients with EPclin "low risk" (or EP "low risk" [EP score <5] if EPclin cannot be calculated after surgery in the neoadjuvant setting) (in all patients, in the relevant target group and separately in men and women and in pre- and postmenopausal women with regard to treatment).

    Measured: 3, 5 and 10 years

  3. OS "low risk"

    Assessment of OS of patients with EPclin "low risk" (or EP "low risk" [EP score <5] if EPclin cannot be calculated after surgery in the neoadjuvant setting) (in all patients, in the relevant target group and separately in men and women and in pre- and postmenopausal women with regard to treatment).

    Measured: 3, 5 and 10 years

  4. DMFS "high risk"

    Assessment of DMFS of patients with EPclin "high risk" in all patients and separated in men and women as well as pre- and postmenopausal women with regard to treatment).

    Measured: 3, 5 and 10 years

  5. DFS "high risk"

    Assessment of DFS of patients with EPclin "high risk" in all patients and separated in men and women as well as pre- and postmenopausal women with regard to treatment).

    Measured: 3, 5 and 10 years

  6. OS "high risk"

    Assessment of OS of patients with EPclin "high risk" in all patients and separated in men and women as well as pre- and postmenopausal women with regard to treatment).

    Measured: 3, 5 and 10 years

  7. DMFS "high risk + low risk"

    DMFS for patients who have / have not been treated according to EPclin/ EP result (all patients and subgroup analyses as specified in secondary objectives 1 and 2).

    Measured: 3, 5 and 10 years

  8. DFS "high risk + low risk"

    DFS for patients who have / have not been treated according to EPclin/ EP result (all patients and subgroup analyses as specified in secondary objectives 1 and 2).

    Measured: 3, 5 and 10 years

  9. OS "high risk + low risk"

    OS for patients who have / have not been treated according to EPclin/ EP result (all patients and subgroup analyses as specified in secondary objectives 1 and 2).

    Measured: 3, 5 and 10 years

  10. Portion of patients tumor board follows the EndoPredict® result

    Assessment of the proportion of patients in whom the tumor board follows the EndoPredict® result in regard to treatment recommendation (in all patients and separately for men and women).

    Measured: 1 year

  11. Portion of patient treated according EndoPredict® result

    Assessment of the proportion of patients who were actually treated according to the EndoPredict® result (in all patients and separately for men and women).

    Measured: 1 year

  12. Prognostic Performance of classical prognostic factors compared to EndoPredict®

    Assessment of the classical prognostic factors tumor size, nodal status, grading, quantitative estrogen receptor, quantitative progesterone receptor and quantitative Ki67 and evaluation of their prognostic performance compared to EPclin and EP in univariate and multivariate analyses of DMFS, DFS, OS (in all patients, separately for men and women, only in patients who have been treated according to the EndoPredict® result).

    Measured: 3, 5 and 10 years

  13. DMFS "low risk vs. high risk"

    Assessment of DMFS of patients with low risk vs. high risk as defined by national (German S3) and international (St. Gallen Consensus) guidelines based on IHC (immunohistochemistry)-classification.

    Measured: 3, 5 and 10 years

  14. DFS "low risk vs. high risk"

    Assessment of DFS of patients with low risk vs. high risk as defined by national (German S3) and international (St. Gallen Consensus) guidelines based on IHC-classification.

    Measured: 3, 5 and 10 years

  15. OS "low risk vs. high risk"

    Assessment of OS of patients with low risk vs. high risk as defined by national (German S3) and international (St. Gallen Consensus) guidelines based on IHC-classification.

    Measured: 3, 5 and 10 years

  16. DMFS of patient proportion of EPclin low and high risk patients in Ki67 low, intermediate and high tumors

    Assessment of proportion of EPclin low and high risk patients in Ki67 low, intermediate and high tumors, respectively, and stratified analysis of DMFS of patients with ki67-values low (≤ 10%)/ intermediate (11-24%)/ high (≥ 25%) and EPclin low risk vs high risk.

    Measured: 3, 5 and 10 years

  17. DFS of patient proportion of EPclin low and high risk patients in Ki67 low, intermediate and high tumors

    Assessment of proportion of EPclin low and high risk patients in Ki67 low, intermediate and high tumors, respectively, and stratified analysis of DFS of patients with ki67-values low (≤ 10%)/ intermediate (11-24%)/ high (≥ 25%) and EPclin low risk vs high risk.

    Measured: 3, 5 and 10 years

  18. OS of patient proportion of EPclin low and high risk patients in Ki67 low, intermediate and high tumors

    Assessment of proportion of EPclin low and high risk patients in Ki67 low, intermediate and high tumors, respectively, and stratified analysis of OS of patients with ki67-values low (≤ 10%)/ intermediate (11-24%)/ high (≥ 25%) and EPclin low risk vs high risk.

    Measured: 3, 5 and 10 years

  19. DMFS "low risk vs. high risk" who have /have not been treated according to the S3 and St. Gallen guidelines

    Assessment of DMFS after 3, 5 and 10 years of patients with low risk vs. high risk as defined by national (German S3) and international (St. Gallen Consensus) guidelines based on IHC-classification.

    Measured: 3, 5 and 10 years

  20. DFS "low risk vs. high risk" who have /have not been treated according to the S3 and St. Gallen guidelines

    Assessment of DFS of patients with low risk vs. high risk as defined by national (German S3) and international (St. Gallen Consensus) guidelines based on IHC-classification.

    Measured: 3, 5 and 10 years

  21. OS "low risk vs. high risk" who have /have not been treated according to the S3 and St. Gallen guidelines

    Assessment of OS of patients with low risk vs. high risk as defined by national (German S3) and international (St. Gallen Consensus) guidelines based on IHC-classification.

    Measured: 3, 5 and 10 years

  22. Chemotherapy regimens

    Description of the given chemotherapy regimens (in all patients and separately for men and women).

    Measured: 1 year

  23. Given endocrine therapy

    Description of the given endocrine therapy (in all patients and separately for men and women).

    Measured: 10 years

  24. Duration of endocrine therapy

    Duration of the endocrine therapy (in all patients and separately for men and women).

    Measured: 10 years

  25. Proportion of patients with prolonged endocrine therapy

    Proportion of patients with EPclin "low risk" and "high risk" respectively who received an extended (> 5 years) endocrine therapy in all patients and separately for men and women).

    Measured: 10 years

  26. DMFS for patients with 5 years of endocrine therapy vs. extended endocrine therapy

    Assessment of DMFS according to EPclin / EP risk class for patients who have received an endocrine therapy for 5 years vs. patients who received an extended endocrine therapy (> 5 years).

    Measured: 10 years

  27. DFS for patients with 5 years of endocrine therapy vs. extended endocrine therapy

    Assessment of DFS according to EPclin / EP risk class for patients who have received an endocrine therapy for 5 years vs. patients who received an extended endocrine therapy (> 5 years).

    Measured: 10 years

  28. OS for patients with 5 years of endocrine therapy vs. extended endocrine therapy

    Assessment of OS according to EPclin / EP risk class for patients who have received an endocrine therapy for 5 years vs. patients who received an extended endocrine therapy (> 5 years).

    Measured: 10 years

  29. Correlation ( pT- and pN data vs. ciT and ciN-data)

    Assessment of the correlation between EPclin, that has been calculated with pT- (pathological tumor size) and pN (pathological nodal status) data and the EPclin based on ciT (clinical/ imaging tumor size) and ciN (clinical/imaging nodal status)-data (in all patients and separately for men and women).

    Measured: 1 year

  30. Concordance ( pT- and pN data vs. ciT and ciN-data)

    Assessment of the concordance between EPclin, that has been calculated with pT- and pN data and the EPclin based on ciT and ciN-data (in all patients and separately for men and women).

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2018
  2. Study start17 Jul 2018
  3. Primary completion1 Oct 2032 (estimated)
  4. Study completion1 Oct 2032 (estimated)

Resources

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
Prospective
Enrolment
1,191 participants (actual)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03503799
Sponsor's protocol ID
NOGGO B3
Acronym
RESCUE
Status last verified
Apr 2026
First submitted
19 Mar 2018
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27400969

  • 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.

    PubMed 25929335

  • 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.

    PubMed 22371223

  • 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.

    PubMed 25836324

  • 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.

    PubMed 24157828

  • 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.

    PubMed 23035151

  • 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.

    PubMed 22152853

  • 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.

    PubMed 28877230

  • 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.

    PubMed 21807638

  • 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.

    PubMed 25867274

  • 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.

    PubMed 23039280

  • 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.

    PubMed 24725534

  • 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.

    PubMed 22447922

  • 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.

    PubMed 23826382

  • 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.

    PubMed 25218890

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Invasive Breast Cancer and Estrogen Receptor Positive Tumor, run by North Eastern German Society of Gynaecological Oncology at 40 sites in 2 countries.

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 8 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Germany, Switzerland. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distant metastasis free survival (time frame: 10 years). 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 NCT03503799, which also lists 15 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 13 Apr 2026.

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