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

Condition(s) studied

Investigational drug(s) / intervention(s)

Endopredict test: 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.

Study 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

Primary outcome measure(s)

• Survival without relapse — 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)

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France

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