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Breast Cancer (Early Breast Cancer)SiMoSeinNCT07379918

Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer

An observational study of Breast Cancer (Early Breast Cancer) and Breast Cancer Survivors, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

EndoPredict is a genomic signature used to determine the 10-year risk of recurrence in early HR+/HER2- breast cancers classified as of intermediate risk according to conventional clinical and pathological criteria, and to guide the adjuvant treatment decision: hormone therapy alone or hormone therapy and chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Endopredict test
How many people
1,000 participants
Where
1 siteFrance
Study dates
28 Jun 2026to 28 Jun 2031
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients included in the SiMoSein prospective database between 2016 and 2021. That is, patients with luminal subtype breast cancer [RE+/HER2-, N+ or N-), at an early stage of the disease, for whom uncertainty remains regarding the decision to administer adjuvant chemotherapy, according to standard clinical-pathological criteria, and for whom an Endopredict genomic signature has been recommended, performed, and interpreted. The study focuses on cancer centers affiliated with UNICANCER and APHP.

Who may be able to join

  • Patient with early breast cancer, hormone receptor-positive, HER2 non-amplified, for whom clinical criteria are deemed insufficient to determine the need for adjuvant chemotherapy, combined with hormone therapy, after breast surgery.

Who cannot join

  • Patients who did not undergo testing or whose test results were not validated

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jacqueline LEHMANN-CHE, MD contact

01 56 09 21 11 ext. +33

jacqueline.lehmann-che@aphp.fr

France1 site, 1 recruiting

  • Hôpital Saint-Louis

    Paris

    Jacqueline LEHMANN-CHE, MD, 01 56 09 21 11 ext. +33, jacqueline.lehmann-che@aphp.fr

    Recruiting

Other trials in France

About this study

Official title: French Prospective Real-life Evaluation of the Endopredict® Genomic Signature for HR-positive,HER2-negative Early Breast Cancer

EndoPredict is a genomic signature used to determine the 10-year risk of recurrence in early HR+/HER2- breast cancers classified as of intermediate risk according to conventional clinical and pathological criteria, and to guide the adjuvant treatment decision: hormone therapy alone or hormone therapy and chemotherapy.

Since 2016, french laboratories performing the Endopredict test, included prospectively analyzed tumors in the SiMoSein registry with data collection : age, tumor size, lymph node status, histology, grade, HR and HER2 IHC status, Ki67, EPscore, Epclin score, risk of relapse, absolue benefit from chemotherapy, risk of late relapse

Read more

The main objectives of the trial are to:

Evaluate long-term relapse-free survival and overall survival over a 10-year period in breast cancer patients who underwent EndoPredict® testing according to:

  • EPclin risk class (low vs. high),
  • Lymph node status (N0/N1),
  • Tumor size (pT),
  • Age groups (<40 years, 40-49 years, 50-69 years, ≥70 years),
  • EP score alone.

This study provide real-life data to determine the clinical usefulness of this molecular signature in the management of early HR+/HER2- breast cancers. The ultimate goal is to be able to offer therapeutic de-escalation (avoiding chemotherapy) to patients who are reliably assessed as having a low risk of relapse.

Being tested
Endopredict test
Keywords
breast cancer, early breast cancer, EndoPredict test, survival, HR positive, HER2 negative
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Endopredict testOther

    Endopredict test was perfomed between 2016 and 2021 in expert french laboratories, for patient with early HR+/HER2-breast cancer presenting insufficient clinical criteria to determine the need for adjuvant chemotherapy, in combination with hormone therapy, after breast surgery.

    Endopredict is a multigene signature that evaluates, on surgery tumor specimen, the expression of 11 genes (8 genes related to proliferation, apoptosis and HR signal transduction pathways and 3 control genes) by qRT-PCR to define a molecular EP score. The Ep score combined with two prognostic factors (tumour size pT and lymph node involvement pN) define the Epclin score. The Epclin score allows calculation of the risk of relapse at 10 years, the absolute benefit from chemoptherapy and the risk of late recurrence.

What is being measured

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

  1. Survival without relapse

    The survival is mesured on 10 years and is defined as absence of metastatic relapse related to cancer in patients which EPclin (score) is low, treated by hormone therapy alone.

    The criterion will be analyzed as a binary variable (event : yes/no)

    Measured: From the moment where the test is perfomed up to 10 years later.

Secondary outcomes (6)

  1. Distant recurrence-free survival and overall survival

    The survival is evaluated on the whole cohort. The criterion will be analyzed as a binary variable (event : yes/no)

    Measured: From the moment where the test is performed up to 10 years later.

  2. Concordance rate between EPclin score and adjuvant treatment administrated

    The alignment between the estimated risk and the chosen treatment strategy is mesured.

    Measured: 10 years after the Endopredict test is perfomed

  3. Rate of change in treatment decision related to EPclin outcome

    The rate of change in treatment decision related to EPclin outcome is measured when the intented treatment before the Endopredict test is available

    Measured: 10 years after the Endopredict is performed

  4. Description of clinical and pathological characteristics

    Statistical description of age, tumor size (pT), lymph node status (pN), grade, Ki67, hormone receptor status (ER/PR), and HER2

    Measured: From the moment where the Endopredict test is performed up to 10 years later

  5. Correlation between clinical and pathological characteristics and EndoPredict® test results

    A correlation is made between EP score and EPclin score.

    Measured: From the moment when the Endopredict test is perfomed to 10 years later

  6. EP Score

    EP score is the EPclin score without clinical and pathological criteria (without tumor size and lymph node invasion).

    Measured: 10 year after the Endopredict test is performed

Timeline

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

  1. First posted2 Feb 2026
  2. Study start28 Jun 2026 (estimated)
  3. Primary completion28 Jun 2031 (estimated)
  4. Study completion28 Jun 2031 (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
Cohort
Time perspective
Other
Enrolment
1,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07379918
Sponsor's protocol ID
APHP251664
Acronym
SiMoSein
Status last verified
Mar 2026
First submitted
23 Jan 2026
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, Geyer CE Jr, Dees EC, Perez EA, Olson JA Jr, Zujewski J, Lively T, Badve SS, Saphner TJ, Wagner LI, Whelan TJ, Ellis MJ, Paik S, Wood WC, Ravdin P, Keane MM, Gomez Moreno HL, Reddy PS, Goggins TF, Mayer IA, Brufsky AM, Toppmeyer DL, Kaklamani VG, Atkins JN, Berenberg JL, Sledge GW. Prospective Validation of a 21-Gene Expression Assay in Breast Cancer. N Engl J Med. 2015 Nov 19;373(21):2005-14. doi: 10.1056/NEJMoa1510764. Epub 2015 Sep 27.

    PubMed 26412349

  • 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

  • Perou CM, Sorlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, Pollack JR, Ross DT, Johnsen H, Akslen LA, Fluge O, Pergamenschikov A, Williams C, Zhu SX, Lonning PE, Borresen-Dale AL, Brown PO, Botstein D. Molecular portraits of human breast tumours. Nature. 2000 Aug 17;406(6797):747-52. doi: 10.1038/35021093.

    PubMed 10963602

  • 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

  • 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

  • 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

  • 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

  • Ferguson MJ, Dewar JA. Tamoxifen beyond 5 years--patients' decisions regarding entry to the aTTom trial. Eur J Cancer. 2002 Sep;38(14):1857-9. doi: 10.1016/s0959-8049(02)00220-4.

    PubMed 12204667

  • - Davies Christina, Pan Hongchao, Godwin Jon, Gray Richard, Arriagada Rodrigo, Raina Vinod, Abraham Mirta, Medeiros Alencar Victor Hugo, Badran Atef, Bonfill Xavier, Bradbury Joan, Clarke Michael, Collins Rory, Davis Susan R, Delmestri Antonella, Forbes John F, Haddad Peiman, Hou Ming-Feng, Inbar Moshe, Khaled Hussein, Kielanowska Joanna, Kwan Wing-Hong, Mathew Beela S, Mittra Indraneel, Müller Bettina, Nicolucci Antonio, Peralta Octavio, Pernas Fany, Petruzelka Lubos, Pienkowski Tadeusz, Radhika Ramachandran, Rajan Balakrishnan, Rubach Maryna T, Tort Sera, Urrútia Gerard, Valentini Miriam, Wang Yaochen, Peto Richard. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet. 2013;381:805-816

  • 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

  • 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

  • Blank PR, Filipits M, Dubsky P, Gutzwiller F, Lux MP, Brase JC, Weber KE, Rudas M, Greil R, Loibl S, Szucs TD, Kronenwett R, Schwenkglenks M, Gnant M. Cost-effectiveness analysis of prognostic gene expression signature-based stratification of early breast cancer patients. Pharmacoeconomics. 2015 Feb;33(2):179-90. doi: 10.1007/s40273-014-0227-x.

    PubMed 25404424

  • Brewster AM, Hortobagyi GN, Broglio KR, Kau SW, Santa-Maria CA, Arun B, Buzdar AU, Booser DJ, Valero V, Bondy M, Esteva FJ. Residual risk of breast cancer recurrence 5 years after adjuvant therapy. J Natl Cancer Inst. 2008 Aug 20;100(16):1179-83. doi: 10.1093/jnci/djn233. Epub 2008 Aug 11.

    PubMed 18695137

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer (Early Breast Cancer) and Breast Cancer Survivors, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

Contact Jacqueline LEHMANN-CHE, MD (01 56 09 21 11 ext. +33, jacqueline.lehmann-che@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival without relapse (time frame: From the moment where the test is perfomed up to 10 years later.). 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 NCT07379918, 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 Mar 2026.

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