Clinical trial Recruiting at 1 site Observational Ages 18 and up Women only

Real-world use of EndoPredict to guide treatment in early HR+/HER2- breast cancer

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

Run by Assistance Publique - Hôpitaux de Paris · NCT07379918 · Data updated 2026-11-12

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.

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Quick facts

Study typeObservational
Ages18 Years and up
SexWomen only
Enrollment1000 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Paris)
StatusRecruiting
StartedJune 28, 2026
Main results expectedJune 28, 2031
Study endsJune 28, 2031
Registry record updatedMarch 13, 2026
Trial IDNCT07379918 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Hôpital Saint-Louis
    Paris, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.