Real-world use of EndoPredict to guide treatment in early HR+/HER2- breast cancer
French Prospective Real-life Evaluation of the Endopredict® Genomic Signature for HR-positive,HER2-negative Early Breast Cancer
This tests whether the EndoPredict genomic test can predict 10-year relapse risk and help decide if people with early HR+/HER2- breast cancer need chemotherapy in addition to hormone therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Paris) |
| Trial ID | NCT07379918 on ClinicalTrials.gov |
What this trial studies
This observational project uses prospectively collected data from French laboratories participating in the SiMoSein registry since 2016 to track outcomes after EndoPredict testing. Clinical, pathological, and genomic data collected include age, tumor size, lymph node status, histology, grade, HR and HER2 IHC, Ki67, EPscore, Epclin score, and estimated absolute chemotherapy benefit. Patients are followed for up to 10 years to measure relapse-free survival and overall survival. Analyses will compare outcomes by EPclin risk class, nodal status (N0/N1), tumor size (pT), and predefined age groups.
Who should consider this trial
Good fit: People with early (non-metastatic) hormone receptor–positive, HER2‑negative breast cancer whose clinical and pathological features leave uncertainty about the need for adjuvant chemotherapy are the intended participants.
Not a fit: Patients with HER2‑positive or metastatic disease, or those whose clinical/pathologic features already clearly indicate for or against chemotherapy, are unlikely to benefit from this testing pathway.
Why it matters
Potential benefit: If successful, this could help doctors avoid unnecessary chemotherapy and better predict 10-year relapse risk for patients with early HR+/HER2- breast cancer.
How similar studies have performed: Prior validation studies and clinical use of EndoPredict and other genomic signatures have shown they can predict recurrence risk and influence treatment decisions, although long-term real-world outcome data remain more limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Hôpital Saint-Louis — Paris, France (Recruiting)
Study contacts
- Study coordinator: Jacqueline LEHMANN-CHE, MD
- Email: jacqueline.lehmann-che@aphp.fr
- Phone: 01 56 09 21 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.