Breast Cancer SurgeryNCT07032220
Application of Targeted Axillary Lymph Node Resection in Axillary Surgery After Neoadjuvant Chemotherapy for Breast Cancer: an Open-label, Multicenter Study
A study testing carbon suspension in people with Breast Cancer Surgery and Neoadjuvant Therapy, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
In this study, following the full informed consent of patients regarding the safety and potential benefits of the new intervention regimen, pathologically confirmed lymph nodes were pre-labeled with carbon nanoparticles prior to neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Surgery, Neoadjuvant Therapy, Sentinel Lymph Node Biopsy (SLNB)
- What is being tested?
- carbon suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2024to 31 Jan 2028
- Phase
- Interventional
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women aged 18-70 years
- The primary breast lesion was confirmed as invasive breast cancer by core needle biopsy
- Axillary lymph node metastasis confirmed by fine needle aspiration or core needle biopsy
- plan to undergo neoadjuvant chemotherapy
- operable breast cancer
- Patients with good heart, lung, liver, and kidney function are suitable for surgery
- Informed consent
Who cannot join
- Surgery is not planned or impossible
- Metastasis of supraclavicular lymph nodes
- distant metastasis, excluding bone metastasis
- previous ipsilateral axillary surgery or radiotherapy
- Due to personal or family factors, the patient is unable to cooperate with the surgical treatment recommended by the doctor according to the condition (breast conserving surgery or radical surgery).
- Patients with severe heart and lung diseases, uncontrolled infectious diseases and other non-tumor related diseases could not tolerate comprehensive treatment such as surgery and chemotherapy
- Unable to sign the informed consent form due to mental illness or other reasons
- Poor medical compliance, and the study group believed that the patients could not complete the trial treatment process and follow-up according to the standard
Trial locations and contacts
1 site in 1 country.
About this study
In this study, following the full informed consent of patients regarding the safety and potential benefits of the new intervention regimen, pathologically confirmed lymph nodes were pre-labeled with carbon nanoparticles prior to neoadjuvant chemotherapy. This was done to investigate the detection rate of carbon nanoparticle-labeled lymph nodes and to assess the stability and safety of carbon nanoparticles. Additionally, the dye single tracer method was employed for sentinel lymph node biopsy to evaluate the false-negative rate of TAD. This is an open-label, single-arm, multi-center prospective clinical trial. The primary objectives of this study are to evaluate the accuracy, feasibility, and safety of this method, thereby improving the quality of life and reducing postoperative complications for breast cancer patients while ensuring treatment efficacy.
- Being tested
- carbon suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon suspensionDrug
Before primary systemic therapy, a core needle biopsy or fine-needle aspiration of the most suspicious axillary lymph node was performed.22 Sterile black carbon suspension (0.5 mL: 25 mg, Chongqing LUMMY Pharmaceutical Co) was injected in the cortex of the metastatic node under ultrasound guidance using a 25G needle by a trained ultrasonographer at the time of biopsy or during a separate session. The injection volume was recorded and varied depending on node size and operator. The trained ultrasonographer had more than 5 years of puncture experience. Of note, for the patients with multiple abnormal nodes or N3 disease under ultrasound at diagnosis, only the pathologically-proven lymph node is marked with carbon suspension.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility and Accuracy of Targeted Axillary Dissection of Carbon Tattooing | Experimental | Not described Receives: Drug: carbon suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
By analyzing the detection rate of TAD, FNR and NPV, the feasibility and accuracy of this method in evaluating axillary lymph nodes of breast cancer patients after neoadjuvant therapy were evaluated.
Measured: 24 months
Secondary outcomes (1)
The feasibility and accuracy of TLNB and SLNB in axillary lymph node evaluation were evaluated by analyzing the detection rate of TLNB and SLNB, FNR and NPV.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start9 Dec 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurgeryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuan Wang, Fujian Medical University Union Hospital
- Investigators
- Chuan Wang, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032220
- Sponsor's protocol ID
- FujianUnions
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Targeted Axillary Lymph Node Resection in Axillary Surgery After Neoadjuvant Chemotherapy for Breast Cancer: an Open-label, Multicenter Study
- ClinicalTrials.gov ID
- NCT07032220
- Acronym / sponsor ID
- FujianUnions
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 22 Jun 2025 (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.
In this study, following the full informed consent of patients regarding the safety and potential benefits of the new intervention regimen, pathologically confirmed lymph nodes were pre-labeled with carbon nanoparticles prior to neoadjuvant chemotherapy. This was done to investigate the detection rate of carbon nanoparticle-labeled lymph nodes and to assess the stability and safety of carbon nanoparticles. Additionally, the dye single tracer method was employed for sentinel lymph node biopsy to evaluate the false-negative rate of TAD. This is an open-label, single-arm, multi-center prospective clinical trial. The primary objectives of this study are to evaluate the accuracy, feasibility, and safety of this method, thereby improving the quality of life and reducing postoperative complications for breast cancer patients while ensuring treatment efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility and Accuracy of Targeted Axillary Dissection of Carbon Tattooing | Experimental | Drug: carbon suspension |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- women aged 18-70 years
- The primary breast lesion was confirmed as invasive breast cancer by core needle biopsy
- Axillary lymph node metastasis confirmed by fine needle aspiration or core needle biopsy
- plan to undergo neoadjuvant chemotherapy
- operable breast cancer
Key exclusion criteria (8 listed)
- Surgery is not planned or impossible
- Metastasis of supraclavicular lymph nodes
- distant metastasis, excluding bone metastasis
- previous ipsilateral axillary surgery or radiotherapy
- Due to personal or family factors, the patient is unable to cooperate with the surgical treatment recommended by the doctor according to the condition (breast conserving surgery or radical surgery).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carbon suspensionBefore primary systemic therapy, a core needle biopsy or fine-needle aspiration of the most suspicious axillary lymph node was performed.22 Sterile black carbon suspension (0.5 mL: 25 mg, Chongqing LUMMY Pharmaceutical Co) was injected in the cortex of the metastatic node under ultrasound guidance using a 25G needle by a trained ultrasonographer at the time of biopsy or during a separate session. The injection volume was recorded and varied depending on node size and operator. The trained ultrasonographer had more than 5 years of puncture experience. Of note, for the patients with multiple abnormal nodes or N3 disease under ultrasound at diagnosis, only the pathologically-proven lymph node is marked with carbon suspension. | Drug | Feasibility and Accuracy of Targeted Axillary Dissection of Carbon Tattooing |
Primary outcome
By analyzing the detection rate of TAD, FNR and NPV, the feasibility and accuracy of this method in evaluating axillary lymph nodes of breast cancer patients after neoadjuvant therapy were evaluated.
Time frame: 24 months
1 secondary outcome
The feasibility and accuracy of TLNB and SLNB in axillary lymph node evaluation were evaluated by analyzing the detection rate of TLNB and SLNB, FNR and NPV.
Time frame: 24 months
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 22 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Chuan Wang principal investigator
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carbon suspension in people with Breast Cancer Surgery and Neoadjuvant Therapy, run by Fujian Medical University Union Hospital 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 7 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
By analyzing the detection rate of TAD, FNR and NPV, the feasibility and accuracy of this method in evaluating axillary lymph nodes of breast cancer patients after neoadjuvant therapy were evaluated. (time frame: 24 months). 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 22 Jun 2025.