French Prospective Real-life Evaluation of the Endopredict® Genomic Signature for HR-positive,HER2-negative Early Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Survival without relapse
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
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
- Distant recurrence-free survival and overall survival(From the moment where the test is performed up to 10 years later.)
- Concordance rate between EPclin score and adjuvant treatment administrated(10 years after the Endopredict test is perfomed)
- Rate of change in treatment decision related to EPclin outcome(10 years after the Endopredict is performed)
- Description of clinical and pathological characteristics(From the moment where the Endopredict test is performed up to 10 years later)
- Correlation between clinical and pathological characteristics and EndoPredict® test results(From the moment when the Endopredict test is perfomed to 10 years later)
- EP Score(10 year after the Endopredict test is performed)