Prospective Validation of a 21-Gene Expression Assay in Breast Cancer.
Joseph A Sparano, Robert J Gray, Della F Makower...
https://pubmed.ncbi.nlm.nih.gov/26412349Actively Recruiting
Age: 18Years +
FEMALE
ID07379918
French Prospective Real-life Evaluation of the Endopredict4 Genomic Signature for HR-positive, HER2-negative Early Breast Cancer
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-13
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the EndoPredict genomic signature to predict the 10-year risk of recurrence in patients with early hormone receptor-positive (HR+), HER2-negative breast cancer who have intermediate risk based on standard clinical and pathological factors. This observational study aims to provide real-world data on how this molecular test can guide decisions about adjuvant treatment, specifically whether hormone therapy alone is sufficient or if chemotherapy should be added. The study also looks at outcomes such as relapse-free survival and overall survival over a 10-year follow-up period. The EndoPredict test was performed on tumor samples collected between 2016 and 2021 in expert French laboratories. It measures the expression of 11 genes related to tumor behavior using qRT-PCR to calculate an EP score, which combined with tumor size and lymph node status produces an EPclin score. This score estimates the risk of relapse and potential benefits from chemotherapy to support treatment decisions after breast surgery. The study follows patients prospectively through the SiMoSein registry collecting detailed clinical, pathological, and molecular data. Participants are involved through data collection of tumor and patient characteristics at the time the EndoPredict test is performed. Researchers will monitor survival without relapse, distant recurrence, and overall survival over 10 years, along with treatment decisions and changes related to EPclin risk classification. The study provides long-term follow-up on the clinical usefulness of this genomic signature in managing early HR+/HER2- breast cancer and aims to identify patients who might safely avoid chemotherapy.
CONDITIONS
Brief Title
Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patients who did not undergo the Endopredict test or whose test results were not validated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Performed between 2016 and 2021
Participants undergo the Endopredict test on surgery tumor specimens to evaluate gene expression and calculate risk scores.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 10 years
Participants are monitored for survival without relapse and other outcomes for up to 10 years after the Endopredict test.
Periodic visits over 10 years
Trial Site Locations
Total: 1 location
1
Hôpital Saint-Louis
Paris, France
Actively Recruiting
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Research Team
J
Jacqueline LEHMANN-CHE, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Preanalytical variables and performance of diagnostic RNA-based gene expression analysis in breast cancer.
Christopher Poremba, Jennifer Uhlendorff, Berit M Pfitzner...
https://pubmed.ncbi.nlm.nih.gov/25218890Molecular portraits of human breast tumours.
C M Perou, T Sørlie, M B Eisen...
https://pubmed.ncbi.nlm.nih.gov/10963602Clinical validation of the EndoPredict test in node-positive, chemotherapy-treated ER+/HER2- breast cancer patients: results from the GEICAM 9906 trial.
Miguel Martin, Jan C Brase, Lourdes Calvo...
https://pubmed.ncbi.nlm.nih.gov/24725534Comparison of the RNA-based EndoPredict multigene test between core biopsies and corresponding surgical breast cancer sections.
Berit Maria Müller, Jan C Brase, Franziska Haufe...
https://pubmed.ncbi.nlm.nih.gov/22447922Decentral gene expression analysis: analytical validation of the Endopredict genomic multianalyte breast cancer prognosis test.
Ralf Kronenwett, Kerstin Bohmann, Judith Prinzler...
https://pubmed.ncbi.nlm.nih.gov/23039280The 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.
F Fitzal, M Filipits, M Rudas...
https://pubmed.ncbi.nlm.nih.gov/25867274A new molecular predictor of distant recurrence in ER-positive, HER2-negative breast cancer adds independent information to conventional clinical risk factors.
Martin Filipits, Margaretha Rudas, Raimund Jakesz...
https://pubmed.ncbi.nlm.nih.gov/21807638Tamoxifen beyond 5 years--patients' decisions regarding entry to the aTTom trial.
M J Ferguson, J A Dewar
https://pubmed.ncbi.nlm.nih.gov/12204667The EndoPredict score provides prognostic information on late distant metastases in ER+/HER2- breast cancer patients.
P Dubsky, J C Brase, R Jakesz...
https://pubmed.ncbi.nlm.nih.gov/24157828