Breast CancerNCT07596472
Ultrasound Monitoring of Clipped Lymph Nodes to Predict Axillary Response After Chemotherapy in Breast Cancer
An observational study of Breast Cancer and Axillary Lymph Node Metastasis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This study aims to evaluate whether longitudinal multimodal ultrasound can accurately predict axillary pathological response in breast cancer patients who receive neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Axillary Lymph Node Metastasis, Neoadjuvant Chemotherapy
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to 20 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Jingsi Mei, +862081332066, meijs@mail.sysu.edu.cn
About this study
Official 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
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.
- Conditions
- Breast Cancer, Axillary Lymph Node Metastasis, Neoadjuvant Chemotherapy, Pathological Complete Response
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients with clipped axillary lymph nodes receiving NAC and ultrasound follow-up. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the time of postoperative pathological assessment (usually within 1 week after surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start20 May 2026 (estimated)
- Primary completion20 May 2027 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596472
- Sponsor's protocol ID
- SYSKY-2025-752-01
- Status last verified
- Apr 2026
- First submitted
- 13 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07596472
- Acronym / sponsor ID
- SYSKY-2025-752-01
- Conditions
- Breast Cancer, Axillary Lymph Node Metastasis, Neoadjuvant Chemotherapy, Pathological Complete Response
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients with clipped axillary lymph nodes receiving NAC and ultrasound follow-up. | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Axillary Lymph Node Metastasis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingsi Mei (+8618825050526, meijs@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.