Positive Node Traced Before Neoadjuvant Chemotherapy (NAC)

Study Overview
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Brief Summary
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To investigate this regression model by injecting and tracing carbon nanoparticles (CNs) into the fusion node prior to NAC in patients with breast cancer.

Detailed Description
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Guided by ultrasound, 0.3 mL of CNs suspension was injected in a fusion node prior to NAC in 110 patients with local advanced breast cancer. Patients underwent breast surgery and total axillary lymph node dissection following 2-6 cycles of NAC. The distribution by intercostobrachial nerves (ICBN) of positive nodes, black-stained nodes and lymphovascular invasion was investigated by response to NAC.

Official Title
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Long-term Tracing for Axillary Lymph Nodes Dissection in the Patients With Fusion Lymph Node Before Neo-adjuvant Chemotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: complete remission (CR) group
* Procedure: partial remission (PR) group
* Procedure: stable disease (SD) group
* Procedure: progressive disease (PD) group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: invasive ductal carcinoma diagnosed by biopsy; clinically positive node diagnosed by contrast enhance computer tomography (CECT), the number of strengthened nodes at Level I ≥ 1 with the longest diameter of the strengthened node ≥ 2cm; NAC regimen followed the NCCN guideline; no prior history of breast cancer or other malignancies. Exclusion Criteria: the cycle number of neo-adjuvant chemotherapy is equal to or less than 2
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: complete remission (CR) group<br>According to the RECIST 1.1, 32 patients were allocated into the complete remission (CR) group based on their responses to neoadjuvant chemotherapy (NAC). | Procedure: complete remission (CR) group<br>* According to the RECIST 1.1, 32 patients were allocated into the complete remission (CR) group based on their responses to neoadjuvant chemotherapy (NAC).<br>|
| Experimental: partial remission (PR) group<br>According to the RECIST 1.1, 61 patients were allocated into the partial remission (PR) group based on their responses to neoadjuvant chemotherapy (NAC). | Procedure: partial remission (PR) group<br>* According to the RECIST 1.1, 61 patients were allocated into the partial remission (PR) group based on their responses to neoadjuvant chemotherapy (NAC).<br>|
| Experimental: stable disease (SD) group<br>According to the RECIST 1.1, 12 patients were allocated into the stable disease (SD) group based on their responses to neoadjuvant chemotherapy (NAC). | Procedure: stable disease (SD) group<br>* According to the RECIST 1.1, 12 patients were allocated into the stable disease (SD) group based on their responses to neoadjuvant chemotherapy (NAC).<br>|
| Experimental: progressive disease (PD) group<br>According to the RECIST 1.1, 5 patients were allocated into the progressive disease (PD) group based on their responses to neoadjuvant chemotherapy (NAC). | Procedure: progressive disease (PD) group<br>* According to the RECIST 1.1, 5 patients were allocated into the progressive disease (PD) group based on their responses to neoadjuvant chemotherapy (NAC).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on pectoralis minor location | After neoadjuvant chemotherapy, whether positive nodes remission (transform to negative), from Level III to Level II, and from Level II to Level I. This means that if the nodes at Level I are negative, the nodes at Level II or Level III will be negative; if the nodes at Level II are negative, the nodes at Level III will be negative; if the nodes at Level III are positive, the nodes at Level I and Level II will be positive. | During the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The spatial distribution of black-stained in axillary after neoadjuvant chemotherapy based on pectoralis minor location | If the chemotherapy is sensitive, the number of black-stained nodes will increase from Level I, Level II, to Level III. If the chemotherapy is resistance, the number of black-stained nodes will remain the original number or a little increasing locally. | During the surgery | 
| The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on intercostobrachiales nerves (ICBN) location | After neoadjuvant chemotherapy, whether positive nodes remission (transform to negative), from above ICBN to below ICBN. This means that if the nodes below ICBN are negative, the nodes above ICBN will be negative; if the nodes above ICBN are positive, the nodes below ICBN will be positive. | During the surgery |