Ultrasound Monitoring of Clipped Lymph Nodes to Predict Axillary Response After Chemotherapy in Breast Cancer

A Prospective Diagnostic Clinical Study Based on Longitudinal Multimodal Ultrasound Evaluation of Clipped Lymph Nodes to Assess Axillary Pathological Response After Neoadjuvant Chemotherapy in Breast Cancer

This study aims to evaluate whether longitudinal multimodal ultrasound can accurately predict axillary pathological response in breast cancer patients who receive neoadjuvant chemotherapy. In this study, patients with biopsy-proven metastatic axillary lymph nodes will have a metallic clip placed in the positive node before chemotherapy. During and after treatment, the clipped lymph node will be monitored by ultrasound, including gray-scale imaging, shear wave elastography, and contrast-enhanced ultrasound. The changes in the morphological and functional features of the clipped node will be analyzed to establish a predictive model for axillary pathological complete response. The results are expected to help identify patients who may safely avoid unnecessary axillary lymph node dissection and improve individualized surgical decision-making.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Neoadjuvant Chemotherapy; Pathological Complete Response; Axillary Lymph Node Metastasis

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Jingsi Mei; Phone Number: +8618825050526; Email: meijs@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Contact: Jingsi Mei; Phone Number: +862081332066; Email: meijs@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically confirmed invasive breast cancer and biopsy-proven metastatic axillary lymph nodes who will receive standard neoadjuvant chemotherapy.

All enrolled patients will have a metallic clip placed in the biopsied positive lymph node before treatment, undergo longitudinal multimodal ultrasound examinations during and after NAC, and finally receive surgery with postoperative pathological evaluation of axillary lymph nodes.

Description

Inclusion Criteria:

• Female patients aged 18 years or older.

Clinical stage of breast cancer: T1-T4, N1-N3, M0.

Axillary lymph node metastasis confirmed by fine-needle aspiration (FNA) or core-needle biopsy.

Indicated for and planned to receive standard neoadjuvant chemotherapy (NAC) regimen.

The biopsy-proven metastatic lymph node is clearly visible on ultrasound and suitable for clip placement.

Completion of NAC followed by breast surgery and axillary lymph node dissection, with complete pathological results available.

Underwent multimodal ultrasound monitoring during NAC, including conventional ultrasound, elastography, and contrast-enhanced ultrasound.

Signed informed consent and willingness to complete all scheduled follow-ups.

Exclusion Criteria:

• Bilateral breast cancer.

Patients who are not suitable for neoadjuvant chemotherapy or plan to receive endocrine or targeted therapy only.

Prior breast or axillary surgery, chemotherapy, or other treatments that may affect the current therapeutic assessment.

Presence of distant metastasis or extensive axillary invasion making clip placement or evaluation difficult.

Pregnant or lactating women.

Poor image quality on ultrasound or other imaging modalities.

Inability to provide informed consent due to psychological, family, or social factors

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Breast cancer patients with clipped axillary lymph nodes receiving NAC and ultrasound follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance of predictive model for axillary pathological complete response (ax-pCR)	Area under the ROC curve (AUC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the multimodal ultrasound-based predictive model for ax-pCR.	At the time of postoperative pathological assessment (usually within 1 week after surgery)
Diagnostic performance of predictive model for axillary pathological complete response (ax-pCR)	Area under the ROC curve (AUC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the multimodal ultrasound-based predictive model for ax-pCR.	At the time of postoperative pathological assessment (usually within 1 week after surgery).

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): May 20, 2027

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: SYSKY-2025-752-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No