Evaluation of Endopredict Genomic Test in Early HR-positive, HER2-negative Breast Cancer A 10-year Study on Risk and Treatment Decisions

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 HRHER2- breast cancer and aims to identify patients who might safely avoid chemotherapy.

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