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NCT07379918 | RECRUITING | Breast Cancer (Early Breast Cancer)

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

Public Assistance - Paris Hospitals

Brief 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.

Condition or disease

Breast Cancer (Early Breast Cancer)

Breast Cancer Survivors

Breast Cancer Prognostic

Early Hormone Receptor-positive (HR-positive)

HER2-negative Breast Cancer

Intervention/treatment

Endopredict test

Study Type : OBSERVATIONAL
Estimated Enrollment : 1000 participants
Official Title : French Prospective Real-life Evaluation of the Endopredict® Genomic Signature for HR-positive,HER2-negative Early Breast Cancer
Actual Study Start Date : 2026-06-28
Estimated Primary Completion Date : 2031-06-28
Estimated Study Completion Date : 2031-06-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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.
Exclusion Criteria
  • * Patients who did not undergo testing or whose test results were not validated
Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer

Location Details

NCT07379918

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

France,

Saint-Louis Hospital

Paris, France,