o Axillary sUrgical Treatment In clinically Lymph node negative patients after UltraSonography[NAUTILUS]: A Prospective, Multicenter, phase III Clinical Trial

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0004840
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 23 March 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 1734

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

•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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5yr Invasive Disease Free Survival

Secondary Outcome Measures

Name	Time	Method
5yr Overall Survival;5yr Distant Metastasis Free Survival;Axilla Recurrence;5yr Locoregional Recurrence Rate;Adverse Events;Quality of Life