Prospective Study Assessing EndoPredict® Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer

Study Overview
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Brief Summary
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The trial population of this study is composed of women aged more than 18, who have developed a newly node-negative (or pN1mi), Estrogen Receptor (ER)-positive, Her2-negative invasive breast cancer with uncertainty on the indication of adjuvant chemotherapy using standard assessments. Obtaining material for test is at no risk as done from the surgery material. Tumor molecular EndoPredict (EP)clin analysis will allow to obtain information on the expression of 8 breast cancer related genes and will provide important prognosis indications. Clinical validation studies have demonstrated that molecular assays are useful for stratifying patients into risk categories and helpful in making clinical treatment decisions in ER+/node-negative breast cancer patients.

Official Title
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Prospective Multicenter Study Assessing EndoPredict® (EP) Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer With Uncertainty on the Indication of Chemotherapy Using Standard Assessments

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: EPClin genomic test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years, Performance status 0 or 1, Patient with newly diagnosed, previously untreated, unilateral, localized, histologically confirmed, invasive breast cancer Fully operated breast cancer including complete resection of breast tumor and adequate axillary surgery Available surgical material (formalin-fixed, paraffin-embedded) for EPclin® evaluation ER-positive by IHC (>10% cells stained or Allred Score≥4) HER2-negative by IHC (score 0 or 1+) and/or Fish/Cish Node-negative or pN1mi (through axillary lymph node examination using sentinel node biopsy or axillary clearance) Uncertainty regarding the toxicity/benefit of adjuvant chemotherapy, outlined inthe following situations: Lobular histology Or grade II Or grade III and pT < 2cm Adequate renal, hepatic, cardiac and hematopoietic functions for a chemotherapy administration Willingness and ability to comply with scheduled visits as well as with test results and chemotherapy decision according to the latest Signed informed consent and Health insurance coverage Exclusion Criteria: Non operable, bilateral, locally advanced, T4 or metastatic breast cancer Any lymph node involvement with the exception of pN0i+ or pN1mi HER2 Overexpression Diagnosis of any previous malignancy within the last 5 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma Any previous systemic or locoregional treatment for the present breast cancer Documented inherited predisposition with BRCA1/2 or TP53 mutation Previous hormone replacement therapy (HRT) stopped less than 2 weeks before surgery Previous treatment for the present breast cancer Person unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EndoPredict (EP)clin testing<br>Once the patient is registered, the most representative block of the primary tumor from surgery (or 10 paraffin slides) are sent to the central analysis platform for EP clin testing. The EPclin method is based on analysis of tumour genes in combination with the classical prognostic factors of nodal status and tumour size. | Other: EPClin genomic test<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients whose choice of treatment is changed as a result of receiving the EPclin genomic test result |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of genomic test results on patient's quality of life (QoL), anxiety levels and satisfaction results using standardized State-Trait-Anxiety Inventory questionnaires compared with general condition at baseline. |  | 1 year | 
| Time required by the centralized platform to perform the test (calculated from the biological sample receipt to the genomic test results). |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genomic test, Chemotherapy decision