None listed
Conditions
Interventions
Procedure/Surgery : This clinical trial is designed as a randomized controlled trial. The study group will omit sentinel lymph node biopsy, while the control group will undergo the procedure. All othe
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Inclusion Criteria: - Women aged =19 years. - Histologically confirmed invasive breast carcinoma treated with neoadjuvant chemotherapy. - Clinical staging prior to NAC: cT1-3, cN0, M0 (AJCC 8th Edition). - If pre-NAC staging is cT1-3, cN1, M0, must meet the following criteria: (1) HER2-positive or triple-negative breast cancer (TNBC). (2) At least 30% reduction in tumor size on MRI after NAC (comparing pre- and post-NAC MRI). - Negative axillary lymph node status on ultrasound after NAC. - Planned for breast-conserving surgery with completed neoadjuvant chemotherapy (at least half the planned regimen must be completed). - ECOG performance status of 0-2. - Signed written informed consent before enrollment.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: - History of any cancer within the past 5 years. - Bilateral breast cancer. - Patients requiring mastectomy. - Tumor size >5 cm after NAC. - Male breast cancer. - Pregnant or breastfeeding women. - Inability to understand and complete questionnaires. - Patients currently participating in other clinical studies related to surgical methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Invasive Disease Free Survival (iDFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Distant Metastasis Free Survival (DMFS);Axillary recurrence rate;Locoregional Recurrence Rate (LRR);Adverse events;Quality of Life | — |
Countries
Korea, Republic of
Contacts
Public ContactWonshik Han
Seoul National University Hospital
Outcome results
None listed