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About
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.
Enrollment
Sex
Ages
Volunteers
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:
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
Primary purpose
Allocation
Interventional model
Masking
203 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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