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NCT Number: NCT07596472

Ultrasound Monitoring of Clipped Lymph Nodes to Predict Axillary Response After 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.

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Key information

Conditions

Breast Cancer Axillary Lymph Node Metastasis Breast Diseases Breast Neoplasms Neoadjuvant Chemotherapy Neoplasms Neoplasms by Site Pathological Complete Response Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location contact

Jingsi Mei

CONTACT

[email protected]

+862081332066

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Diagnostic performance of predictive model for axillary pathological complete response (ax-pCR)

Time frame: At the time of postoperative pathological assessment (usually within 1 week after surgery)

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.
Diagnostic performance of predictive model for axillary pathological complete response (ax-pCR)

Time frame: At the time of postoperative pathological assessment (usually within 1 week after surgery).

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jingsi Mei

CONTACT

[email protected]

+8618825050526

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: May 19, 2026
Registry last updated: May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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