NCT07379918 Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer
| NCT ID | NCT07379918 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Breast Cancer (Early Breast Cancer) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-06-28 |
| Primary Completion | 2031-06-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2026-06-28 with a primary completion date of 2031-06-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07379918 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer (Early Breast Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07379918 currently recruiting?
Yes, NCT07379918 is actively recruiting participants. Contact the research team at jacqueline.lehmann-che@aphp.fr for enrollment information.
Where is the NCT07379918 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT07379918 clinical trial?
NCT07379918 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 1,000 participants.
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