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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06212440
Other study ID # 2010242-2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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