None listed
Conditions
Interventions
Procedure/Surgery : The study arm gets breast conserving surgery performed, while the control arm gets both breast conserving surgery and sentinel lymph node biopsy performed. Additional surgical proc
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: • Women = 19 years • Invasive unilateral breast carcinoma with histological confirmation • History of invasive breast cancer • Histologically or radiologically no suspicion of distant metastases • Performance status corresponding to ECOG grade 0-2 • Tumor size clinically and radiologically = 5cm, independent of hormone receptor and HER2 status • Clinically and sonographically negative axillary lymph nodes before biopsy; core needle biopsy or fine needle aspiration of suspicious lymph node required • BCS candidate with postoperative whole-breast irradiation and adequate systemic therapy • No psychological and geographical restriction in follow-up • Written informed consent
Exclusion criteria
Exclusion criteria: • History of any cancer in the previous 5 years • Bilateral breast cancer • Invasive breast cancer treated with neoadjuvant therapy • Tumor size clinically and radiologically > 5cm • Mastectomy candidate • Pregnancy and breastfeeding • Male breast cancer • Unable to understand and fill out questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5yr Invasive Disease Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 5yr Overall Survival;5yr Distant Metastasis Free Survival;Axilla Recurrence;5yr Locoregional Recurrence Rate;Adverse Events;Quality of Life | — |
Countries
Korea, Republic of
Contacts
Public ContactJi Gwang Jung
Seoul National University Hospital
Outcome results
None listed