Status:
ACTIVE_NOT_RECRUITING
No Axillary sUrgical Treatment In Clinically Lymph Node Negative Patients After UltraSonography
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
National Evidence-Based Healthcare Collaborating Agency
Conditions:
Breast Cancer
Sentinel Lymph Node
Eligibility:
FEMALE
19+ years
Phase:
NA
Brief 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 ...
Detailed Description
\[Background\] Skipping ALND, the follow-up treatment in SN-positive patients, has non-inferior oncological outcomes compared to SLNB-only group, given that there is no severe SN metastases. Axillary...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2027
Estimated Enrollment :
1734 Patients enrolled
Trial Details
Trial ID
NCT04303715
Start Date
September 15 2020
End Date
December 31 2027
Last Update
December 4 2023
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080