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Breast cancer breakthrough: thousands may avoid unnecessary surgery

NCT ID NCT04303715

Knowledge-focused Sponsor: Seoul National University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether women with small breast cancers (under 5 cm) and no signs of cancer in their lymph nodes on ultrasound can safely skip sentinel lymph node biopsy during breast-conserving surgery. About 1,734 women are being randomly assigned to either have the biopsy or not, and researchers will track cancer recurrence and survival over time. The goal is to reduce unnecessary surgery and side effects without harming outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1,734 people

The number who actually took part.

Started

Sep 2020

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm invasive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Sentinel lymph node

Contacts and locations

Locations

  • Seoul National University Hospital

    Seoul, Seoul, 03080, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.