Axillary Lymph Node Changes After Neoadjuvant Therapy In Breast Cancer

N/AActive Not RecruitingNCT07428720

Institute of Oncology Ljubljana97 enrolled

Overview

The purpose of this study is to improve regional surgical treatment in breast cancer patients with axillary lymph node metastases (cN+) who received neoadjuvant systemic treatment (NAST) by using ultrasound elastography.

This study aims to optimize regional surgical treatment in breast cancer patients with axillary lymph node metastases (cN+) after neoadjuvant systemic treatment (NAST). Ultrasound elastography will be validated as a method for identifying metastases or regressive posttreatment changes in removed axillary lymph nodes.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Cancer Axillary Lymph Node Metastasis

Interventions

Ultrasound ElastographyDEVICE

Ultrasound elastography is used to assess axillary lymph nodes in order to identify metastases or regressive posttreatment changes after neoadjuvant systemic treatment.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female patients aged 18 years or older * Histologically confirmed breast cancer * Clinically positive axillary lymph nodes before neoadjuvant systemic treatment (cN+) * Completed neoadjuvant systemic treatment (NAST) * Planned axillary surgery (sentinel lymph node biopsy and/or axillary lymph node dissection) * Ability to provide written informed consent Exclusion Criteria: * Age \< 18 years * Male patients * Metastatic disease at diagnosis * Inflammatory breast cancer * New primary breast cancer * Bilateral breast cancer * Pregnancy * Previous breast or axillary surgery

Locations (1)

Institute of Oncology Ljubljana

Ljubljana, Slovenia

Outcomes

Primary Outcomes

Diagnostic Accuracy of Intraoperative Ultrasound Elastography for Detection of Residual Axillary Lymph Node Metastasis After NAST

Diagnostic accuracy of intraoperative ultrasound elastography performed on excised axillary lymph nodes for detection of residual metastatic disease after neoadjuvant systemic treatment (NAST), using histopathological examination of excised lymph nodes as the reference standard. Diagnostic performance will be reported as sensitivity (%), specificity (%), positive predictive value (PPV, %), and negative predictive value (NPV, %).

Time frame: Intraoperative (during surgery) after completion of neoadjuvant systemic treatment (NAST).

Secondary Outcomes

Diagnostic Accuracy of Intraoperative Ultrasound Elastography for Detection of Regressive Posttreatment Changes in Axillary Lymph Nodes After NAST

Diagnostic accuracy of intraoperative ultrasound elastography performed on excised axillary lymph nodes for detection of regressive posttreatment changes after neoadjuvant systemic treatment (NAST), using histopathological examination as the reference standard. Diagnostic performance will be reported as sensitivity (%), specificity (%), PPV (%), and NPV (%).

Time frame: Intraoperative (during surgery) after completion of neoadjuvant systemic treatment (NAST).

Data from ClinicalTrials.gov

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