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Can a tiny clip spare breast cancer patients full lymph node removal?

NCT ID NCT07828925

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are studying a technique to remove fewer lymph nodes in women with breast cancer that has spread to the lymph nodes and who receive chemotherapy before surgery. The approach uses a clip placed in the affected node to guide surgeons during a selective axillary dissection. The study tracks whether the clipped node matches the sentinel node and how often patients avoid a full node removal. About 105 women will take part.

What this could mean

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

What this could lead to
If the clip reliably marks the right node, doctors could remove fewer lymph nodes during surgery, which may lower the risk of arm swelling and nerve problems after breast cancer treatment.
What could go wrong
This is an observational study, not a randomized trial, so it can show patterns but cannot prove that selective dissection is as safe as standard full dissection. The technique may miss cancer in other nodes, and the results may not apply to all patients.

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

105 people

The number who actually took part.

Started

Feb 2018

Finished

Sep 2020

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

Female Patients in both pre and post menopausal stage with a diagnosis of Lymphonode Positive Breast Cancer that have to undergo to neoadjuvant chemotherapy

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: * Age\>= 18 years * Female sex * Diagnosis of Lymph Node- Positive (cN+) Breast Cancer through core needle biopsy, cT1-3 (multifocal too) * Absence of distant metastases (M0) * Patients that will undergo to NACT Exclusion Criteria: * Previous diagnosis of Breast Cancer * Previous Breast and/or Axillary Surgery * Pregnancy * Inflammatory Breast Cancer (cT4) * Patients that will not undergo to NACT

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Conditions

The condition(s) this trial relates to.

breast neoplasm female breast carcinoma

As listed by the trial registrant

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

Breast cancer female

Contacts and locations

Locations

  • Radiology Department- Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168, Italy

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