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NAUTILUS-04: No Axillary Surgical Treatment in Low-Risk Clinically Node-Negative Breast Cancer Without Whole-Breast Radiotherapy
Sponsor: Wonshik Han
Summary
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.
Official title: A Multicenter Randomized Controlled Non-Inferiority Trial of No Axillary Surgical Treatment in Low-Risk Clinically Node-Negative Breast Cancer Without Whole-Breast Radiotherapy
Key Details
Gender
FEMALE
Age Range
55 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1520
Start Date
2026-10-01
Completion Date
2034-10-01
Last Updated
2026-10-08
Healthy Volunteers
No
Interventions
Omission of axillary surgery
Planned breast surgery is performed without any axillary surgical procedure. Neither sentinel lymph node biopsy nor axillary lymph node dissection is performed. Adjuvant treatment decisions are made without pathologic nodal information
Sentinel lymph node biopsy
Sentinel lymph node biopsy is performed at the time of planned breast surgery. Subsequent axillary management and adjuvant treatment decisions follow institutional standard practice based on the pathologic nodal findings.
Locations (1)
Seoul National University Hospital
Seoul, South Korea