Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement (UTAD)

European Institute of Oncology

Status: Enrolling

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

Treatments: Procedure: Upfront Targeted Axillary Dissection (UTAD)

Study type: Observational

Funder types: Other

Identifiers

NCT07278726

UID 5132

L2-439 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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