No Axillary sUrgical Treatment In Clinically Lymph Node Negative Patients After UltraSonography[NAUTILUS]: A Prospective, Multicenter, Phase III Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,734
- 试验地点
- 1
- 主要终点
- Disease Free Survival (DFS)
研究概览
简要总结
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.
详细描述
[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 ultrasound can effectively exclude high nodal burden, showing 95% NPV in a systematic review.
SLNB has morbidity including lymphedema, limited range of motion, pain, and other post-surgical complications, eventually leading to reduced quality of life.
Considering improvement of imaging modalities and adjuvant care, survival outcome of SLNB must be re-evaluated. Especially research reflective of the regional specificities of Korea and Asia-Pacific is needed.
[Study design] Prospective, Multicenter, RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
No SLNB group
The study arm - BCS without SLNB
干预措施: No SLNB (Procedure)
SLNB group
The Control Arm - BCS with SLNB(+/-ALND)
干预措施: SLNB (Procedure)
结局指标
主要结局
Disease Free Survival (DFS)
时间窗: 5 years
Evaluate disease free survivals
次要结局
- QoL(1 year)
- Overall Survival (OS)(5 years)
- Locoregional Recurrence Rate (LRR)(5 years)
- Patient reported Adverse Events (AEs)(1 year)
- Distant Metastasis Free Survival (DMFS)(5 years)
- Axillary recurrence rate(5 years)