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Armpit surgery after chemo: unnecessary for some breast cancer patients?

NCT ID NCT06704945

Disease control 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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether women with breast cancer who have no signs of cancer in their armpit lymph nodes after chemotherapy can safely skip armpit surgery. About 464 participants will be randomly assigned to either have or skip the surgery. The goal is to see if skipping surgery is just as good at preventing cancer from coming back over 5 years.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 464 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2034

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 aged ≥19 years. * Histologically confirmed invasive breast carcinoma treated with neoadjuvant chemotherapy. * Clinical staging prior to NAC: cT1-3, cN0, M0 (AJCC 8th Edition). * If pre-NAC staging is cT1-3, cN1, M0, must meet the following criteria: 1. HER2-positive or triple-negative breast cancer (TNBC). 2. At least 30% reduction in tumor size on MRI after NAC (comparing pre- and post-NAC MRI). * Negative axillary lymph node status on ultrasound after NAC. * Planned for breast-conserving surgery with completed neoadjuvant chemotherapy (at least half the planned regimen must be completed). * ECOG performance status of 0-2. * Signed written informed consent before enrollment. Exclusion Criteria: * History of any cancer within the past 5 years. * Bilateral breast cancer. * Patients requiring mastectomy. * Tumor size \>5 cm after NAC. * Male breast cancer. * Pregnant or breastfeeding women. * Inability to understand and complete 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 Neoadjuvant therapy Sentinel lymph node biopsy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Seoul National University Hopsital

    RECRUITING

    Seoul, 03080, South Korea

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