Positive Node Traced Before Neoadjuvant Chemotherapy (NAC)

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: complete remission (CR) group; Procedure: partial remission (PR) group; Procedure: stable disease (SD) group; Procedure: progressive disease (PD) group

• Registration Number: NCT03355261
• Lead Sponsor: Shengjing Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-07-01
• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-28
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
complete remission (CR) group	complete remission (CR) group	According to the RECIST 1.1, 32 patients were allocated into the complete remission (CR) group based on their responses to neoadjuvant chemotherapy (NAC).
partial remission (PR) group	partial remission (PR) group	According to the RECIST 1.1, 61 patients were allocated into the partial remission (PR) group based on their responses to neoadjuvant chemotherapy (NAC).
stable disease (SD) group	stable disease (SD) group	According to the RECIST 1.1, 12 patients were allocated into the stable disease (SD) group based on their responses to neoadjuvant chemotherapy (NAC).
progressive disease (PD) group	progressive disease (PD) group	According to the RECIST 1.1, 5 patients were allocated into the progressive disease (PD) group based on their responses to neoadjuvant chemotherapy (NAC).

Primary Outcome Measures

Name	Time	Method
The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on pectoralis minor location	During the surgery	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.

Secondary Outcome Measures

Name	Time	Method
The spatial distribution of black-stained in axillary after neoadjuvant chemotherapy based on pectoralis minor location	During the surgery	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.
The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on intercostobrachiales nerves (ICBN) location	During the surgery	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.

Trial Locations

Locations (3)

The Second Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

the First Affiliated Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China