RecruitingNCT07379918

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

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

1,000 participants

Start Date

Jun 28, 2026

Study Type

OBSERVATIONAL

Conditions

HER2-negative Breast Cancer Breast Cancer (Early Breast Cancer)Breast Cancer Survivors Breast Cancer Prognostic Early Hormone Receptor-positive (HR-positive)

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. 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 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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates how the Endopredict genomic test (a test that analyzes tumor genes to estimate recurrence risk) is used in real-world clinical practice to guide decisions about whether to add chemotherapy to hormonal therapy for early-stage hormone receptor-positive, HER2-negative breast cancer. **You may be eligible if...** - You have early-stage breast cancer that is hormone receptor-positive and HER2-negative - Your doctor cannot determine from standard clinical factors alone whether you need chemotherapy after breast surgery - You have undergone the Endopredict genomic test **You may NOT be eligible if...** - You did not undergo the Endopredict test, or your test results were not validated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEREndopredict test

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.