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Two biopsy methods together may spare some breast cancer patients a bigger surgery

NCT ID NCT07791771

Diagnosis Sponsor: Peking University Cancer Hospital & Institute Source: ClinicalTrials.gov ↗

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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.
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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 Results may not be published yet.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)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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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
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First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This study tests whether combining two lymph node biopsy methods, sentinel lymph node biopsy and wire localized lymph node biopsy, can accurately identify breast cancer patients with only limited lymph node spread. The goal is to see if these patients can safely skip a more invasive procedure called axillary lymph node dissection, which removes more lymph nodes and carries higher risks of side effects. Researchers will enroll 84 women with early-stage breast cancer who have one or two suspicious lymph nodes on ultrasound, all confirmed to contain cancer. The main question is how many of these women have two or fewer positive lymph nodes after the combined biopsy, which would suggest the less invasive approach is sufficient.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sentinel lymph node biopsy combined with wire localized lymph node biopsy
What this could lead to
If this approach works, some breast cancer patients with limited lymph node spread could avoid a more invasive axillary lymph node dissection, reducing side effects like arm swelling.
What could go wrong
This is a small diagnostic study, not a treatment trial. The combined biopsy may not reliably identify all patients with low lymph node burden, and the results need confirmation in larger studies.

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 84 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

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.

Who is studied

This prospective observational cohort study will enroll female patients with invasive breast cancer who have clinically node-negative axilla on physical examination, but 1-2 abnormal axillary lymph nodes detected by ultrasound and confirmed metastatic by biopsy. Eligible patients will have cT1-2 breast cancer without distant metastasis and will undergo sentinel lymph node biopsy combined with wire localized lymph node biopsy. A total of 84 patients will be included.

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: 1. Female patients pathologically confirmed with primary invasive breast cancer via core needle biopsy; 2. Aged 18 years or older; 3. No enlarged lymph nodes palpable in the axilla on clinical examination; ultrasound reveals 1 or 2 abnormal ipsilateral axillary lymph nodes with malignant features (cortical thickening \>3 mm, hypoechoic, etc.), and at least one of them is confirmed metastatic by biopsy; 4. Maximum diameter of breast tumor ≤5 cm (cT1-2); 5. No distant metastasis detected on tumor staging examinations; 6. No prior neoadjuvant therapy received; 7. Sentinel lymph node biopsy combined with wire-localized lymph node biopsy completed by attending physicians per routine clinical practice; 8. Patients meet one of the following criteria for combined lymph node biopsy results and surgical management: total number of positive lymph nodes is 1-2 with breast-conserving surgery and omission of axillary lymph node dissection; or total number of positive lymph nodes is 1-2 with modified radical mastectomy; or total number of positive lymph nodes exceeds 2, with axillary lymph node dissection performed regardless of breast-conserving surgery or total mastectomy; 9. Voluntarily participating in this observational study and signing an informed consent form. Exclusion Criteria: 1. Bilateral breast cancer; 2. Stage IV breast cancer; 3. Receipt of neoadjuvant therapy prior to surgery; 4. Previous ipsilateral axillary surgery history (e.g., osmidrosis surgery, lymph node biopsy) and history of axillary radiotherapy; 5. Coexistence of other malignant tumors within the past 5 years, excluding cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc.; 6. Pregnant or lactating women; 7. Severe cardiac and pulmonary insufficiency precluding surgical tolerance.

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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

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

  • Peking University Cancer Hospital

    Beijing, 100142, China

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