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Ultrasound may spare breast cancer patients unnecessary surgery

NCT ID NCT07596472

Diagnosis Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether a special ultrasound can accurately detect if breast cancer has completely disappeared from lymph nodes after chemotherapy. About 150 women with cancer that spread to their lymph nodes will have a small clip placed in a cancerous node before treatment. Doctors will then use different ultrasound techniques to track changes in that node. If the ultrasound can reliably show the cancer is gone, some women may be able to safely skip a more invasive surgery to remove lymph nodes.

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.

Participants

About 150 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 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.

Who is studied

Patients with histologically confirmed invasive breast cancer and biopsy-proven metastatic axillary lymph nodes who will receive standard neoadjuvant chemotherapy. All enrolled patients will have a metallic clip placed in the biopsied positive lymph node before treatment, undergo longitudinal multimodal ultrasound examinations during and after NAC, and finally receive surgery with postoperative pathological evaluation of axillary lymph nodes.

Ages

18 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: * Female patients aged 18 years or older. Clinical stage of breast cancer: T1-T4, N1-N3, M0. Axillary lymph node metastasis confirmed by fine-needle aspiration (FNA) or core-needle biopsy. Indicated for and planned to receive standard neoadjuvant chemotherapy (NAC) regimen. The biopsy-proven metastatic lymph node is clearly visible on ultrasound and suitable for clip placement. Completion of NAC followed by breast surgery and axillary lymph node dissection, with complete pathological results available. Underwent multimodal ultrasound monitoring during NAC, including conventional ultrasound, elastography, and contrast-enhanced ultrasound. Signed informed consent and willingness to complete all scheduled follow-ups. Exclusion Criteria: * Bilateral breast cancer. Patients who are not suitable for neoadjuvant chemotherapy or plan to receive endocrine or targeted therapy only. Prior breast or axillary surgery, chemotherapy, or other treatments that may affect the current therapeutic assessment. Presence of distant metastasis or extensive axillary invasion making clip placement or evaluation difficult. Pregnant or lactating women. Poor image quality on ultrasound or other imaging modalities. Inability to provide informed consent due to psychological, family, or social factors

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm metastatic malignant neoplasm in the lymph nodes

As listed by the trial registrant

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

Axillary lymph node metastasis Breast cancer Neoadjuvant chemotherapy Pathological complete response

How to take part

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  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

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510000, China

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