Positive Node Traced Before Neoadjuvant Chemotherapy (NAC)

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03355261
• Other study ID #: ShengjingH01
• Status: Completed
• Phase: N/A
• Start date: July 1, 2014
• Est. completion date: July 1, 2018

Study information

• Verified date: February 2020
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• 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
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
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
According to the RECIST 1.1, 5 patients were allocated into the progressive disease (PD) group based on their responses to neoadjuvant chemotherapy (NAC).

Locations

Country	Name	City	State
China	The Second Hospital of Jilin University	Changchun	Jilin
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	the First Affiliated Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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