Table 1.

Enrollment criteria.

Inclusion
A. Before surgery (clinical evaluation)
•Age ≥ 18 and ≤ 75 years
•Infiltrating breast carcinoma (cytology/core biopsy)
•Tumor size cT1-cT2-cT3 (ultrasound/mammography)
•Positive axillary nodes (cN+) at presentation (clinical visit, ultrasound and possibly cyto-microhistology)
•Neoadjuvant chemotherapy (NAC) undergone (anthracycline/taxane based) followed by SLNB
•Axillary nodes downstaged to clinically negative (cN-) after NAC (clinical visit, ultrasound and possibly cyto-microhistology)
•No previous infiltrating breast carcinoma
•No distant metastases (M0)
•Signed and dated written informed consent
B. Intra-operative or post-surgery (definitive pathological diagnosis)
B1. Inclusion in the experimental group
✓Infiltrating breast carcinoma
✓Tumor size pT1-pT2-pT3
✓Micrometastases (>0.2 mm-≤2 mm, ypN1mi) in up to 3 SLNs
B.2 Inclusion in the standard group
✓Infiltrating breast carcinoma
✓Tumor size pT1-pT2-pT3
✓Absence of metastasis (ypN0) or ITC (ypN0(i+) in the SLN
Exclusion
•Ongoing pregnancy or breast-feeding
•Inflammatory breast cancer
•In situ breast carcinoma
•Concomitant contralateral breast carcinoma
•Comorbidity, chronic life-threatening disease or psychological conditions precluding the compliance to a regular follow-up
•Previous neoplasm within the 3 years preceding inclusion (except for in situ carcinoma of the cervix, basalioma, squamous cell carcinoma or non melanoma skin carcinoma
SLNB, sentinel lymph node biopsy; NAC, neoadjuvany chemotherapy; SLN, sentinel lymph node; ITC, isolated tumor cell