Axillary Lymph Node Changes After Neoadjuvant Therapy In Breast Cancer

Implications Of Posttreatment Changes In Axillary Lymph Nodes And Axillary Surgical Procedure Optimization In Breast Cancer Patients After Neoadjuvant Systemic Treatment

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07428720

Enrollment

Registered

2026-02-24

Start date

2022-09-01

Completion date

2027-12-31

Last updated

2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Axillary Lymph Node Metastasis

Keywords

Ultrasound Elastography, Axillary Lymph Nodes, Neoadjuvant Systemic Treatment

Brief summary

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.

Detailed description

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.

Interventions

DEVICEUltrasound Elastography

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Single-group study evaluating ultrasound elastography for identification of metastases or regressive changes in removed axillary lymph nodes after neoadjuvant systemic treatment.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic Accuracy of Intraoperative Ultrasound Elastography for Detection of Residual Axillary Lymph Node Metastasis After NAST	Intraoperative (during surgery) after completion of neoadjuvant systemic treatment (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, %).

Secondary

Measure	Time frame	Description
Diagnostic Accuracy of Intraoperative Ultrasound Elastography for Detection of Regressive Posttreatment Changes in Axillary Lymph Nodes After NAST	Intraoperative (during surgery) after completion of neoadjuvant systemic treatment (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 (%).

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026