Breast Cancer (Early Breast Cancer)NAUTILUS-04NCT07841704
NAUTILUS-04: No Axillary Surgical Treatment in Low-Risk Clinically Node-Negative Breast Cancer Without Whole-Breast Radiotherapy
A study testing Omission of axillary surgery and Sentinel lymph node biopsy in people with Breast Cancer (Early Breast Cancer) and Sentinel Lymph Node Biopsy, run by Wonshik Han at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Breast Cancer (Early Breast Cancer), Sentinel Lymph Node Biopsy
- What is being tested?
- Omission of axillary surgery and Sentinel lymph node biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,520 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2026to 1 Oct 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Hospital
Seoul, 03080
Wonshik Han, Professor, 82-2-2072-0706, hanw@snu.ac.kr
About this study
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
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.
Read more
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.
- Being tested
- Omission of axillary surgery, Sentinel lymph node biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omission of axillary surgeryProcedure or 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 biopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| SLN omission group | Experimental | No axillary surgery Receives: Procedure: Omission of axillary surgery |
| SLN group | Active comparator | Sentinel lymph node biopsy Receives: Procedure: Sentinel lymph node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive disease free survival
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.
Measured: 5 years after randomization
Secondary outcomes (4)
Overall survival
Description: Overall survival is defined as the time from randomization to death from any cause.
Measured: 5 years from randomization
Distant disease-free survival
Distant disease-free survival is defined as the time from randomization to the first occurrence of distant recurrence or death from any cause, according to the STEEP criteria.
Measured: 5 years from randomization
Axillary recurrence
Axillary recurrence is defined as histologically or cytologically confirmed recurrence in the ipsilateral axillary lymph nodes, occurring as a first event or concurrently with other recurrence sites.
Measured: 5 years from randomization
Health-related quality of life
Health-related quality of life assessed by the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires. Scores are linearly transformed to a 0-100 scale. Higher scores on functional scales indicate better functioning, whereas higher scores on symptom scales indicate greater symptom burden.
Measured: Before surgery, and 1 and 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2034 (estimated)
- Study completion1 Oct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer (Early Breast Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, randomized, parallel-group, non-inferiority trial comparing omission of axillary surgery with standard axillary surgery in patients with low-risk clinically node-negative breast cancer.
- Masking
- None (open label)
- Enrolment
- 1,520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wonshik Han
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wonshik Han, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841704
- Sponsor's protocol ID
- NAUTILUS-04
- Acronym
- NAUTILUS-04
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07841704
- Acronym / sponsor ID
- NAUTILUS-04 / NAUTILUS-04
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,520 participants (estimated)
- Lead sponsor
- Wonshik HanUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2034 (estimated)
- Study completion
- 1 Oct 2034 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multicenter, randomized, parallel-group, non-inferiority trial comparing omission of axillary surgery with standard axillary surgery in patients with low-risk clinically node-negative breast cancer.
| Arm | Type | Receives |
|---|---|---|
| SLN omission group | Experimental | Procedure: Omission of axillary surgeryNo axillary surgery |
| SLN group | Active comparator | Procedure: Sentinel lymph node biopsySentinel lymph node biopsy |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (7 listed)
- Clinically or radiologically suspicious axillary lymph nodes
- Prior ipsilateral invasive breast cancer or prior axillary surgery
- Bilateral breast cancer
- Inflammatory breast cancer
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omission of axillary surgeryPlanned 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 | Procedure or surgery | SLN omission group |
| Sentinel lymph node biopsySentinel 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. | Procedure or surgery | SLN group |
Primary outcome
Invasive disease free survival
Time frame: 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.
4 secondary outcomes
Overall survival
Time frame: 5 years from randomization
Distant disease-free survival
Time frame: 5 years from randomization
Axillary recurrence
Time frame: 5 years from randomization
Health-related quality of life
Time frame: Before surgery, and 1 and 2 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omission of axillary surgery and Sentinel lymph node biopsy in people with Breast Cancer (Early Breast Cancer) and Sentinel Lymph Node Biopsy, run by Wonshik Han at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wonshik Han, Professor (82-2-2072-0706, hanw@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive disease free survival (time frame: 5 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.