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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-28

Study Completion Date

2033-11-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Upfront Targeted Axillary Dissection (UTAD)

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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