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Clinical Trials in South Korea / NCT04303715
Active, not recruiting Not applicable

No Axillary sUrgical Treatment In Clinically Lymph Node Negative Patients After UltraSonography

NCT04303715 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Hospital
Phase
Not applicable
Started
2020-09-15
Last updated
2026-02-13

Condition(s) studied

Breast CancerSentinel Lymph Node

Investigational drug(s) / intervention(s)

No SLNBSLNB

No SLNB: BCS only. Ommission of SLNB by axilla ultrasonography among selective breast cancer patients

SLNB: BCS with SLNB(+/-ALND)

Study summary

NAUTILUS study is a prospective, multicenter, RCT. Clinically T1,T2, node negative BCS candidates with no evidence of metastases in AUS are 1:1 randomized into no SLNB group and SLNB group.

NAUTILUS study aim to establish the minimally invasive treatment of breast cancer by reexamining the necessity of sentinel lymph node biopsy among patients with invasive breast cancer who have tumors under 5cm, are clinically node-negative, and are having breast conserving surgery performed.

Eligibility

Sex
FEMALE
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Disease Free Survival (DFS) — 5 years
    Evaluate disease free survivals

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul Seoul

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04303715 on ClinicalTrials.gov ↗ ← All trials in South Korea