Breast Cancer (Early Breast Cancer), Breast Cancer Prognostic, Breast Cancer Survivors, Early Hormone Receptor-positive (HR-positive), HER2-negative Breast Cancer
Conditions
Keywords
breast cancer, early breast cancer, EndoPredict test, survival, HR positive, HER2 negative
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.
Interventions
OTHEREndopredict 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.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distant recurrence-free survival and overall survival | 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) |
| Concordance rate between EPclin score and adjuvant treatment administrated | 10 years after the Endopredict test is perfomed | The alignment between the estimated risk and the chosen treatment strategy is mesured. |
| Rate of change in treatment decision related to EPclin outcome | 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 |
| Description of clinical and pathological characteristics | 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 |
| Correlation between clinical and pathological characteristics and EndoPredict® test results | From the moment when the Endopredict test is perfomed to 10 years later | A correlation is made between EP score and EPclin score. |
| EP Score | 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). |
Countries
France
Contacts
CONTACTJacqueline LEHMANN-CHE, MD
Outcome results
None listed