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ALNDUTADNCT07278726

Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement

An observational study of ALND and Sentinel Lymph Node Biopsy (SLNB), run by European Institute of Oncology at 14 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The present study aims to avoid axillary lymph node dissection (ALND) in patients with an Ultrasound (US) detected positive preoperative lymph node involvement (1 or 2 suspicious lymph-nodes) and a needle histology/cytology placing a marker in the most suspicious node undergoing upfront surgery if neoadjuvant… Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Upfront Targeted Axillary Dissection (UTAD)
Type of treatment
Surgery or procedure
How many people
150 participants
Where
14 sitesin 2 countries
Study dates
28 Jan 2026to Nov 2033
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Viviana Galimberti, MD contact

+39 0257489717

viviana.galimberti@ieo.it

14 sites in 2 countries

Italy13 sites, 13 recruiting

  • IRCCS AOU di Bologna - Policlinico di Sant'Orsola

    Bologna, Italy, 40138

    Marco Bernini, MD, +39 051 2143344, marco.bernini@aosp.bo.it

    Marco Bernini, MD

    Not yet recruiting

  • AUSL Romagna - Presidio Ospedaliero Morgagni-Pierantoni

    Forlì, Italy, 47121

    Annalisa Curcio, MD, +39 0543731676, annalisa.curcio@auslromagna.it

    Annalisa Curcio, MD

    Recruiting

  • European Institute of Oncology

    Milan, Italy, 20141

    Viviana Galimberti, MD, +39 0257489717, viviana.galimberti@ieo.it

    Viviana Galimberti, MD

    Recruiting

  • Fondazione IRCCS Istituto Nazionale Tumori di Milano

    Milan, Italy, 20133

    Massimiliano Gennaro, MD, +39 0223902659, Massimiliano.Gennaro@istitutotumori.mi.it

    Massimiliano Gennaro, MD

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Federico II

    Naples, Italy, 80131

    Nicola Rocco, MD, +39 0817462896

    Not yet recruiting

  • Presidio Ospedaliero "G. Bernabeo"

    Ortona, Italy, 66026

    Simona Grossi, MD, +39 085 9172228, sgrossi@unich.it

    Simona Grossi, MD

    Not yet recruiting

  • Policlinico San Matteo

    Pavia, Italy, 27100

    Angelica Della Valle, MD, +39 0328 501809, A.DellaValle@smatteo.pv.it

    Angelica Della Valle, MD

    Recruiting

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, Italy, 56100

    Matteo Ghilli, MD, +39 050 993139, m.ghilli@ao-pisa.toscana.it

    Matteo Ghilli, MD

    Not yet recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, Italy, 00136

    Gianluca Franceschini, MD, +39 06 9779 1378, gianluca.franceschini@policlinicogemelli.it

    Gianluca Franceschini, MD

    Recruiting

  • AO San Giovanni Addolorata

    Roma, Italy, 00184

    Lucio Fortunato, MD, +39 0677055112, lfortunato@hsangiovanni.roma.it

    Lucio Fortunato, MD

    Not yet recruiting

  • IRCCS Humanitas Research Hospital

    Rozzano, Italy, 20089

    Damiano Gentile, MD, +39 0282246252, damiano.gentile@humanitas.it

    Damiano Gentile, MD

    Recruiting

  • Azienda sanitaria universitaria Giuliano Isontina

    Trieste, Italy, 34148

    Serena Scomersi, MD, +39 040 3994152, serena.scomersi@asugi.sanita.fvg.it

    Serena Scomersi, MD

    Not yet recruiting

  • ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi

    Varese, Italy, 21100

    Corrado Chiappa, MD, +39 0332 278342, corrado.chiappa@asst-settelaghi.it

    Corrado Chiappa, MD

    Not yet recruiting

Other trials in Italy

Switzerland1 site, 1 recruiting

  • Ente Ospedaliero Cantonale

    Lugano, Switzerland, CH-6500

    Nickolas Peradze, MD, +41 (0)91 811 76 96, Nickolas.Peradze@eoc.ch

    Nickolas Peradze, MD

    Not yet recruiting

Other trials in Switzerland

About this study

Official title: Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement: the UTAD Study of the Italian National Association of Breast Surgeons (ANISC)

The present study aims to avoid axillary lymph node dissection (ALND) in patients with an Ultrasound (US) detected positive preoperative lymph node involvement (1 or 2 suspicious lymph-nodes) and a needle histology/cytology placing a marker in the most suspicious node undergoing upfront surgery if neoadjuvant treatment is not indicated. The marked lymph node will be retrieved along with sentinel lymphnode(SLN)(s) to minimize the false-negative rate and only in case of ≥3 positive SLNs ALND will be performed, in order to minimize surgical overtreatment among women with preoperatively confirmed axillary nodal metastasis.

Read the detailed description

The patients that will avoid axillary lymph node dissection (ALND) meet all the criteria listed in the latest NCCN guidelines version.

Being tested
Upfront Targeted Axillary Dissection (UTAD)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Upfront Targeted Axillary Dissection (UTAD)Procedure or surgery

    During the surgical intervention lymphnodes excised both with reflector localization and Gamma probe will be sent for pathological examination and only in case of more than 2 metastatic lymph nodes (and at least one of them with macrometastasis) axillary dissection will be performed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful rate of the retrieval of the deflector.

    Number of successful retrieval of the deflector on the total number of surgeries.

    Measured: Perioperative/Periprocedural

  2. Prevention of Axillary Lymph Node Dissection

    Total number of patient that did not received but were elegible for Axillary Lymph Node Dissection by the current guidelines on the total number of surgeries.

    Measured: Perioperative/Periprocedural

Secondary outcomes (1)

  1. Axillary recurrence rate

    The secondary endpoint is the rate of axillary recurrence in patients undergoing UTAD and who avoid AD. Cumulative incidence of axillary recurrence as first event will be calculated, considering the following events as competing: distant metastases, death, second primary malignancies, invasive ipsilateral tumor recurrences in the breast or chest wall, supraclavicular or internal mammary recurrences, and contralateral invasive cancers.

    Measured: 5 years from surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2025
  2. Study start28 Jan 2026
  3. Primary completionNov 2028 (estimated)
  4. Study completionNov 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07278726
Sponsor's protocol ID
UID 5132
Other IDs
L2-439
Acronym
UTAD
Status last verified
Jun 2026
First submitted
17 Nov 2025
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of ALND and Sentinel Lymph Node Biopsy (SLNB), run by European Institute of Oncology at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Viviana Galimberti, MD (+39 0257489717, viviana.galimberti@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful rate of the retrieval of the deflector. (time frame: Perioperative/Periprocedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07278726.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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