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NCT Number: NCT07379918

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

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.

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Key information

Conditions

Breast Cancer (Early Breast Cancer) Breast Cancer Prognostic Breast Cancer Survivors Breast Diseases Breast Neoplasms Early Hormone Receptor-positive (HR-positive) HER2-negative Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endopredict test

Other

Endopredict test was perfomed between 2016 and 2021 in expert french laboratories, for patient with early HR+/HER2-breast cancer presenting insufficient clinical criteria to determine the need for adjuvant chemotherapy, in combination with hormone therapy, after breast surgery.

Endopredict is a multigene signature that evaluates, on surgery tumor specimen, the expression of 11 genes (8 genes related to proliferation, apoptosis and HR signal transduction pathways and 3 control genes) by qRT-PCR to define a molecular EP score. The Ep score combined with two prognostic factors (tumour size pT and lymph node involvement pN) define the Epclin score. The Epclin score allows calculation of the risk of relapse at 10 years, the absolute benefit from chemoptherapy and the risk of late recurrence.

Primary outcomes

  1. Survival without relapse

    Time frame: From the moment where the test is perfomed up to 10 years later.

    The survival is mesured on 10 years and is defined as absence of metastatic relapse related to cancer in patients which EPclin (score) is low, treated by hormone therapy alone.

    The criterion will be analyzed as a binary variable (event : yes/no)

Secondary outcomes

  1. Distant recurrence-free survival and overall survival

    Time frame: From the moment where the test is performed up to 10 years later.

    The survival is evaluated on the whole cohort. The criterion will be analyzed as a binary variable (event : yes/no)

  2. Concordance rate between EPclin score and adjuvant treatment administrated

    Time frame: 10 years after the Endopredict test is perfomed

    The alignment between the estimated risk and the chosen treatment strategy is mesured.

  3. Rate of change in treatment decision related to EPclin outcome

    Time frame: 10 years after the Endopredict is performed

    The rate of change in treatment decision related to EPclin outcome is measured when the intented treatment before the Endopredict test is available

  4. Description of clinical and pathological characteristics

    Time frame: From the moment where the Endopredict test is performed up to 10 years later

    Statistical description of age, tumor size (pT), lymph node status (pN), grade, Ki67, hormone receptor status (ER/PR), and HER2

  5. Correlation between clinical and pathological characteristics and EndoPredict® test results

    Time frame: From the moment when the Endopredict test is perfomed to 10 years later

    A correlation is made between EP score and EPclin score.

  6. EP Score

    Time frame: 10 year after the Endopredict test is performed

    EP score is the EPclin score without clinical and pathological criteria (without tumor size and lymph node invasion).

Study contacts

Contact information is provided by the study sponsor or research team.

Jacqueline LEHMANN-CHE, MD

CONTACT

[email protected]

01 56 09 21 11 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: SiMoSein

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Feb 2, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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