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
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 |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | National cancer center | Goyang | Gyeonggi |
Korea, Republic of | National Cancer Center | Goyang-si | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
National Cancer Center, Korea |
Korea, Republic of,
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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