Axillary Lymph Node Changes After Neoadjuvant Therapy In Breast Cancer

NCT07428720 | Active Not Recruiting

• 2 other identifiers: ERID-KSOPKR-0041/20220120-178/2022/3
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Axillary Lymph Node Metastasis

Keywords

Ultrasound Elastography; Axillary Lymph Nodes; Neoadjuvant Systemic Treatment

Outcome Measures

Primary Outcomes (1)

• 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, %).

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

Secondary Outcomes (1)

• 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).

Study Arms (1)

Ultrasound Elastography Assessment

EXPERIMENTAL

Breast cancer patients with axillary lymph node metastases (cN+) after neoadjuvant systemic treatment undergo ultrasound elastography assessment to identify metastases or regressive changes in axillary lymph nodes.

Device: Ultrasound Elastography

Interventions

Ultrasound Elastography DEVICE

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

Ultrasound Elastography Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 24, 2026
• Study Start: September 1, 2022
• Primary Completion: March 1, 2023
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)