Positive Node Traced Before Neoadjuvant Chemotherapy (NAC)

China Medical University

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: complete remission (CR) group; Procedure: partial remission (PR) group; Procedure: stable disease (SD) group; Procedure: progressive disease (PD) group

Study type: Interventional

Funder types: Other

Identifiers

NCT03355261

ShengjingH01

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 4 patient groups

complete remission (CR) group

Experimental group

Description:

According to the RECIST 1.1, 32 patients were allocated into the complete remission (CR) group based on their responses to neoadjuvant chemotherapy (NAC).

Treatment:

Procedure: complete remission (CR) group

partial remission (PR) group

Experimental group

Description:

According to the RECIST 1.1, 61 patients were allocated into the partial remission (PR) group based on their responses to neoadjuvant chemotherapy (NAC).

Treatment:

Procedure: partial remission (PR) group

stable disease (SD) group

Experimental group

Description:

According to the RECIST 1.1, 12 patients were allocated into the stable disease (SD) group based on their responses to neoadjuvant chemotherapy (NAC).

Treatment:

Procedure: stable disease (SD) group

progressive disease (PD) group

Experimental group

Description:

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

Treatment:

Procedure: progressive disease (PD) group