Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT02773004
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02773004
Study Brief:
Protocol Section:
NCT02773004