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

Breast Neoplasm Clinical Trial

Official title:

Clinical Application of Multi-modal Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Chemotherapy : Expanded Access Clinical Study in 3 Arms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06212440
• Other study ID #: 2010242-2
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2024
• Source: National Cancer Center, Korea
• Contact: Seeyoun Lee, Doctor
• Phone: +82-31-920-1736
• Email: seeyoun[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 348
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Neoadjuvant Therapy
• Sentinel Lymph Node Biopsy

Intervention

Diagnostic Test:
• Identification rate of sentinel lymph node for each dual method
Direct comparison of identification rate between A arm and B arm, A arm and C arm.

Locations

Country	Name	City	State
Korea, Republic of	National cancer center	Goyang	Gyeonggi
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification rate of sentinel lymph node	Collection of data for detection rate of sentinel lymph node for each group following direct comparison between each arms.	during operation
Secondary	Comparison of operation time for sentinel lymph node biopsy	collection of data for operation time between skin incision and detection of sentinel lymph node, following direct comparison between each arms	during operation