Clinical Application of Multi-modal Sentinel Lymph Node Staining Method in Breast Cancer Patients After Neoadjuvant Chemotherapy

Not Applicable

Completed

• Conditions: Sentinel Lymph Node Biopsy; Breast Neoplasm; Neoadjuvant Therapy
• Interventions: Diagnostic Test: Identification rate of sentinel lymph node for each dual method

• Registration Number: NCT06212440
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

This clinical trial aimed to confirm the effectiveness of sentinel lymph node surgery by determining the lymph node identification rate using multimodal sentinel lymph node marker methods in patients with advanced breast cancer undergoing neoadjuvant chemotherapy (NAC).

Detailed Description

After NAC, the sentinel lymph node (SLN) identification rate is lower, and it has a higher false-negative rate than that in early-stage breast cancer. As appropriate SLN surgery directly affects the treatment and prognosis of patients undergoing NAC, evaluation to identify SLN using various methods is necessary.

This clinical trial aimed to confirm the effectiveness of sentinel lymph node surgery by determining the lymph node identification rate using multimodal sentinel lymph node marker methods in patients with advanced breast cancer undergoing neoadjuvant chemotherapy (NAC).

Study Timeline

• Study Start: 2021-05-04
• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-18
• Primary Completion: 2024-08-14
• Study Completion: 2024-10-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 348

Inclusion Criteria

• The patient with locally advanced breast cancer who achieved neoadjuvant chemotherapy
• Confirmed operability with imaging study after neoadjuvant chemotherapy
• Age over 20 years old
• ECOG Performance status : 0-2
• The patient with written informed consent form

Exclusion Criteria

• The patient with previous ipsilateral breast cancer history
• The patinet with previous ipsilateral axillary surgical procedure (e.g. excisional or incisional biopsy, axillary dissection)
• The patient without neoadjuvant chemotherapy
• Inoperable imaging study after neoadjuvant chemotherapy
• Inflammatory breast cancer
• Pregnant patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	Identification rate of sentinel lymph node for each dual method	Sentinel LN biopsy by mapping with vital dye and Fluorescence (ICG-F)
B	Identification rate of sentinel lymph node for each dual method	Sentinel LN biopsy by mapping with Radioactive isotope(RI) and vital dye
A	Identification rate of sentinel lymph node for each dual method	Sentinel LN biopsy by mapping with Radioactive isotope(RI) and Indocyanine Green Fluorescence (ICG-F)

Primary Outcome Measures

Name	Time	Method
Identification rate of sentinel lymph node	during operation	Collection of data for detection rate of sentinel lymph node for each group following direct comparison between each arms.

Secondary Outcome Measures

Name	Time	Method
Comparison of operation time for sentinel lymph node biopsy	during operation	collection of data for operation time between skin incision and detection of sentinel lymph node, following direct comparison between each arms

Trial Locations

Locations (2)

National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

National cancer center; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of