An interventional study of Omission of axillary surgery and Sentinel lymph node biopsy in Breast Cancer (Early Breast Cancer) and Sentinel Lymph Node Biopsy, sponsored by Wonshik Han. Not yet recruiting at 1 site in South Korea. Open to female participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Wonshik Han · Not applicable, Interventional, and Treatment
Among 617 studies in Breast Neoplasms with a site in Korea, Republic of — 133 open to participants now, 230 under way, 75 of them phase 3. Breast Neoplasms · Korea, Republic of.
Among the 617 studies in Breast Neoplasms with a site in Korea, Republic of, this one is the 37th largest by planned enrollment of the 505 interventional ones that give a count, is one of 18 that started in 2026, is one of 90 with no phase, reaches primary completion later than 227 of the 229 other live ones, and was the 617th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →133 of the 617 studies in Breast Neoplasms with a site in Korea, Republic of are open now. Recruiting first, the newest first:
Daiichi Sankyo · Sites in Korea, Republic of, United States, Belgium and 5 more countries
Samsung Medical Center · Sites in Korea, Republic of
AstraZeneca · Sites in Korea, Republic of, United States, France and 6 more countries
Novartis Pharmaceuticals · Sites in Korea, Republic of, United States, Canada and 6 more countries
BeOne Medicines · Sites in Korea, Republic of, United States, Australia and 13 more countries
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 55 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
617 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 104 · Phase 2 181 · Phase 3 177 · Phase 4 14
First in 2001; this study’s year is marked. 18 started in 2026.
This study's planned enrollment of 1,520 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 218 across the 505 interventional studies, 422 across the 108 observational. Of the 303 that completed or were terminated, 148 (49%) have results posted.
This tab as a report to print or save as PDF → With an account.
348 of 617 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Wonshik Han as lead sponsor.
Wonshik Han has 1 study filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
46 of the studies in Breast Neoplasms with a site in Korea, Republic of that are under way reach primary completion within a year, 15 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05646862Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | 2026-11-13 |
| NCT04639986Phase 3Gilead SciencesAsian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC) | 2026-12 |
| NCT05894239Phase 3Hoffmann-La RocheA Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer | 2026-12-31 |
| NCT05440149Phase 3Seoul National University HospitalThe Postoperative Radiotherapy in N1 Breast Cancer Patients | 2026-12-31 |
| NCT04873362Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy | 2027-03-31 |
Among the 617 studies in Breast Neoplasms with a site in Korea, Republic of, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No axillary surgery
Procedure: Omission of axillary surgery
Sentinel lymph node biopsy
Procedure: Sentinel lymph node biopsy
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 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.
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.
Time frame: 5 years after randomization
Overall survival
Description: Overall survival is defined as the time from randomization to death from any cause.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before surgery, and 1 and 2 years after surgery
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 12 months after publication of the primary results, ending 3 years thereafter
Access criteria: Requests should be directed to the principal investigator. Proposals will be reviewed by the study steering committee. Data will be shared after approval of the proposal and completion of a data access agreement.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2034, 96 months later.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 96 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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