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New breast cancer surgery could spare women from unnecessary lymph node removal

NCT ID NCT07278726

Disease control Sponsor: European Institute of Oncology 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is for women with early-stage luminal breast cancer that has spread to 1 or 2 lymph nodes. Instead of removing many lymph nodes from the armpit, surgeons will remove only the marked suspicious node and the sentinel nodes. If fewer than 3 nodes are positive, full lymph node removal is avoided, which may reduce side effects like arm swelling. The study aims to see if this targeted approach is safe and effective.

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.

Started

Jan 2026

Expected to finish

Nov 2033

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 diagnosed with T0-T1-T2 ER+ HER2- breast cancer with limited nodal involvement (1 or 2 suspicious lymph node on US, with at least 1 positive nodal citology/histology) M0 for whom neoadjuvant treatment is not recommended after a multidisciplinary discussion, between 18 and 90 years old willing and able to follow the study procedures and available for follow-up over the entire duration of the study.

Ages

18 to 90 years

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: * Diagnosis of T0-T1-T2 ER+/PR+ HER2- breast cancer with limited nodal involvement (1 or 2 suspicious lymph node on US, with at least 1 nodal positive cytology/histology) * M0 * Conservative surgery or mastectomy * Neoadjuvant treatment not recommended after a multidisciplinary discussion * Patients between 18 and 90 years old * Patients willing and able to follow the study procedures and available for follow-up over the entire duration of the study Exclusion Criteria: * Psychiatric, addictive or any disorder, which compromises ability to give informed consent for participation in the study * Personal history of invasive breast cancer * Other invasive malignancies diagnosed in the last five years * Any condition that may expose the individual to a higher risk or preclude the study from achieving full compliance or completion * Contraindications to radiation therapy

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Conditions

The condition(s) this trial relates to.

breast tumor luminal A or B hormone receptor-positive breast cancer

As listed by the trial registrant

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

ALND Sentinel lymph node biopsy (SLNB) Targeted axillary dissection (TAD)

How to take part

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

  1. The places running it

    14 sites in 2 countries. 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

  • AO San Giovanni Addolorata

    NOT_YET_RECRUITING

    Roma, Italy, 00184, Italy

  • ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi

    NOT_YET_RECRUITING

    Varese, Italy, 21100, Italy

  • AUSL Romagna - Presidio Ospedaliero Morgagni-Pierantoni

    RECRUITING

    Forlì, Italy, 47121, Italy

  • Azienda Ospedaliera Universitaria Federico II

    NOT_YET_RECRUITING

    Naples, Italy, 80131, Italy

  • Azienda Ospedaliera Universitaria Pisana

    NOT_YET_RECRUITING

    Pisa, Italy, 56100, Italy

  • Azienda sanitaria universitaria Giuliano Isontina

    NOT_YET_RECRUITING

    Trieste, Italy, 34148, Italy

  • Ente Ospedaliero Cantonale

    NOT_YET_RECRUITING

    Lugano, Switzerland, CH-6500, Switzerland

  • European Institute of Oncology

    RECRUITING

    Milan, Italy, 20141, Italy

  • Fondazione IRCCS Istituto Nazionale Tumori di Milano

    NOT_YET_RECRUITING

    Milan, Italy, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Roma, Italy, 00136, Italy

  • IRCCS AOU di Bologna - Policlinico di Sant'Orsola

    NOT_YET_RECRUITING

    Bologna, Italy, 40138, Italy

  • IRCCS Humanitas Research Hospital

    RECRUITING

    Rozzano, Italy, 20089, Italy

  • Policlinico San Matteo

    RECRUITING

    Pavia, Italy, 27100, Italy

  • Presidio Ospedaliero "G. Bernabeo"

    NOT_YET_RECRUITING

    Ortona, Italy, 66026, Italy

More trials for these conditions

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