Prospective Study Assessing EndoPredict® Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UNICANCER
With
Myriad Genetics, Inc.
Age
18–75
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Prospective Study Assessing EndoPredict® Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer
