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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06212440

Enrollment

348

Registered

2024-01-18

Start date

2021-05-04

Completion date

2024-10-02

Last updated

2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasm, Neoadjuvant Therapy, Sentinel Lymph Node Biopsy

Keywords

breast cancer, sentinel node biopsy, neoadjuvant chemotherapy

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).

Interventions

DIAGNOSTIC_TESTRadioactive Isotope (RI) Mapping

Administered via peritumoral or subareolar injection for sentinel lymph node detection.

DIAGNOSTIC_TESTIndocyanine Green Fluorescence (ICG-F) Mapping

Administered via peritumoral or subareolar injection, detected using near-infrared fluorescence imaging.

DIAGNOSTIC_TESTVital Dye Mapping

Administered via peritumoral or subareolar injection for intraoperative visualization of lymphatic drainage pathways.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

open-label, prospective, single-institution, 3-arms expended randomized study

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026