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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 348
- Locations
- 4
- Primary Endpoint
- Identification rate of sentinel lymph node
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Identification rate of sentinel lymph node
Time Frame: during operation
Collection of data for detection rate of sentinel lymph node for each group following direct comparison between each arms.
Secondary Outcomes
- Comparison of operation time for sentinel lymph node biopsy(during operation)
Investigators
Seeyoun Lee
Doctor, M.D., head of center for breast cancer
National Cancer Center, Korea