No Axillary Surgical Treatment in Low-Risk Clinically Node-Negative Breast Cancer Without Whole-Breast Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,520
- 试验地点
- 1
- 主要终点
- Invasive disease free survival
研究概览
简要总结
The safety of omitting sentinel lymph node biopsy (SLNB) has been established only in patients undergoing breast-conserving surgery with whole-breast radiotherapy, as demonstrated in the prior randomized trials. Whether SLNB can be omitted in patients who will not receive whole-breast radiotherapy remains unknown, despite the parallel expansion of radiotherapy de-escalation in low-risk populations.
NAUTILUS-04 is a prospective, multicenter, randomized, phase III non-inferiority trial evaluating the oncologic safety of SLNB omission in postmenopausal patients with low-risk, clinically node-negative breast cancer who are not planned to receive whole-breast radiotherapy.
Eligible patients are postmenopausal women aged 55 years or older with estrogen receptor-positive, HER2-negative invasive breast cancer, clinical T1-2 and clinically node-negative disease confirmed by physical examination and axillary ultrasound, without neoadjuvant systemic therapy. Patients must be planned for one of three local treatments: breast-conserving surgery without radiotherapy, breast-conserving surgery with accelerated partial breast irradiation, or mastectomy without radiotherapy.
A total of 1,520 patients will be randomized 1:1 to SLNB or no axillary surgery, stratified by planned breast surgery (breast-conserving surgery versus mastectomy) and age (55-64 versus 65 years or older). The primary endpoint is 5-year invasive disease-free survival. Secondary endpoints include 5-year axillary recurrence-free survival, distant recurrence-free survival, overall survival, and quality of life assessed by the EORTC QLQ questionnaire.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women aged 55 years or older
- •Histologically confirmed invasive breast cancer
- •Estrogen receptor-positive and HER2-negative
- •Clinical T1-2
- •Clinically node-negative by physical examination and axillary ultrasound
- •No neoadjuvant systemic therapy
- •Not planned to receive whole-breast radiotherapy
- •Planned for one of the following local treatments:
- •Cohort 1: Breast-conserving surgery without radiotherapy
- •Age under 65 years with clinical T1 tumor and biologically low risk, defined as Oncotype DX Recurrence Score 18 or less, OncoFREE Decision Index 15 or less, or Ki-67 13.25% or less with histologic grade 1 or 2
- •Age 65 years or older with clinical tumor size 3 cm or less and histologic grade 1 or 2
- •Cohort 2: Breast-conserving surgery with accelerated partial breast irradiation, with clinical T1 tumor and histologic grade 1 or 2
- •Cohort 3: Mastectomy without radiotherapy, with histologic grade 1 or 2
- •Written informed consent
排除标准
- •Clinically or radiologically suspicious axillary lymph nodes
- •Prior ipsilateral invasive breast cancer or prior axillary surgery
- •Bilateral breast cancer
- •Inflammatory breast cancer
- •Pregnancy
- •Any condition that precludes protocol-specified surgery or follow-up
- •Concurrent participation in another interventional clinical trial that may affect the primary endpoint of this study
研究组 & 干预措施
SLN omission group
No axillary surgery
干预措施: Omission of axillary surgery (Procedure)
SLN group
Sentinel lymph node biopsy
干预措施: Sentinel lymph node biopsy (Procedure)
结局指标
主要结局
Invasive disease free survival
时间窗: 5 years after randomization
Invasive disease-free survival is defined as the time from randomization to the first occurrence of invasive ipsilateral breast tumor recurrence, local or regional invasive recurrence, distant recurrence, contralateral invasive breast cancer, second primary invasive cancer, or death from any cause, according to the STEEP criteria.
次要结局
- Overall survival(5 years from randomization)
- Distant disease-free survival(5 years from randomization)
- Axillary recurrence(5 years from randomization)
- Health-related quality of life(Before surgery, and 1 and 2 years after surgery)
研究者
Wonshik Han
Professor, Department of surgery
Seoul National University Hospital