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

NCT07278726 | Recruiting

• 2 other identifiers: UID 5132L2-439
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 14

Brief 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 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.

Conditions

ALND; Sentinel Lymph Node Biopsy (SLNB); Targeted Axillary Dissection (TAD)

Outcome Measures

Primary Outcomes (2)

• Successful rate of the retrieval of the deflector.

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

  Perioperative/Periprocedural

• 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.

  Perioperative/Periprocedural

Secondary Outcomes (1)

• Axillary recurrence rate

  5 years from surgery.

Interventions

Upfront Targeted Axillary Dissection (UTAD) PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (14)

IRCCS AOU di Bologna - Policlinico di Sant'Orsola

Bologna, Italy, 40138, Italy

NOT YET RECRUITING

AUSL Romagna - Presidio Ospedaliero Morgagni-Pierantoni

Forlì, Italy, 47121, Italy

NOT YET RECRUITING

European Institute of Oncology

Milan, Italy, 20141, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale Tumori di Milano

Milan, Italy, 20133, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Federico II

Naples, Italy, 80131, Italy

NOT YET RECRUITING

Presidio Ospedaliero "G. Bernabeo"

Ortona, Italy, 66026, Italy

NOT YET RECRUITING

Policlinico San Matteo

Pavia, Italy, 27100, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Pisana

Pisa, Italy, 56100, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, 00136, Italy

NOT YET RECRUITING

AO San Giovanni Addolorata

Roma, Italy, 00184, Italy

NOT YET RECRUITING

IRCCS Humanitas Research Hospital

Rozzano, Italy, 20089, Italy

RECRUITING

Azienda sanitaria universitaria Giuliano Isontina

Trieste, Italy, 34148, Italy

NOT YET RECRUITING

ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi

Varese, Italy, 21100, Italy

NOT YET RECRUITING

Ente Ospedaliero Cantonale

Lugano, Switzerland, CH-6500, Switzerland

NOT YET RECRUITING

Central Study Contacts

Viviana Galimberti, MD

CONTACT

+39 0257489717; viviana.galimberti@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 12, 2025
• Study Start: January 28, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2033
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (13); CH (1)