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Could fewer lymph nodes be removed in breast cancer surgery?

NCT ID NCT04998682

Knowledge-focused Sponsor: University of Miami 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This completed study looked at whether sampling just a few lymph nodes under the arm can tell if breast cancer has spread, instead of removing many nodes. Twenty patients with advanced breast cancer at diagnosis took part. The goal was to see if this targeted approach could reduce the extent of surgery while still catching cancer that has spread.

What this could mean

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

Active substance
Axillary dissection (surgical procedure)
What this could lead to
If successful, this could help doctors remove fewer lymph nodes in breast cancer patients, reducing side effects like arm swelling.
What could go wrong
This is a small, completed study with only 20 participants, so results may not apply to all patients. The approach may not be accurate enough for widespread use.

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

20 people

The number who actually took part.

Started

Mar 2022

Finished

Feb 2026

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

18 years and older

Sex

Anyone

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 or men greater than or equal to 18 years. * Histologically confirmed invasive adenocarcinoma of the breast. * Clinical T0-4 N2-3 M0 at diagnosis (American Joint Committee on Cancer, 7th Edition) * Assessment for cN2 disease will be performed by clinical exam and imaging. Patients should have pathologic level 1 and/or 2 axillary lymph nodes which are fixed/matted on physical exam. * Cross-sectional imaging will be used to identify advanced nodal disease involving the axilla, infraclavicular, supraclavicular, and internal mammary regions, cN3 disease. * Patients must have biopsy proven involvement of the axillary lymph nodes. * Receipt of standard multiagent chemotherapy +/- targeted therapy based on tumor subtype. * Candidate for surgical management of breast cancer. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * History of allergic reactions or hypersensitivity to radioactive lymph node mapping agents or blue dye. * Pregnancy.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • University of Miami

    Miami, Florida, 33136, United States

More trials for these conditions

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