Photo-medicine-Guided Dual Approach for Reoperation of Sentinel Lymph Nodes in Locally Recurrent Breast Cancer Patients

Sentinel lymph node biopsy (SLNB) is essential for staging and treatment planning in early breast cancer patients. As a less invasive procedure, it has replaced axillary lymph node dissection (ALND) by reducing complications and improving patient outcomes. However, the 10-year local recurrence rate for breast cancer is approximately 2-10%, and the role of SLNB in the surgical management of recurrent breast cancer remains unclear.

According to the NCCN guidelines and Korean Breast Cancer Treatment Recommendations, surgical management for recurrent breast cancer includes mastectomy and axillary lymph node surgery for patients who have previously undergone breast-conserving surgery and radiotherapy. For axillary recurrence, surgery is recommended if feasible, followed by radiotherapy. Conversely, the ASCO guidelines recommend SLNB for surgically resectable recurrent breast cancer, and recent studies have reported promising outcomes for repeat sentinel lymph node biopsy (reSLNB). Vugts G et al. demonstrated an 80.1% tumor-negative rate with reSLNB, suggesting that ALND could be avoided in many cases.

Although reSLNB offers the advantage of reducing unnecessary invasive procedures and associated complications, challenges remain due to disrupted lymphatic pathways in patients who have previously undergone surgery and radiotherapy. Additionally, research on the long-term prognosis of these patients is still limited.

This study aims to evaluate the detection rate of sentinel lymph nodes using a photo-medicine-based dual localization technique that combines traditional radiotracer methods with indocyanine green-fluorescence (ICG-F) in patients undergoing reSLNB for locally recurrent breast cancer.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Locally Recurrent Breast Cancer; Sentinel Lymph Node Biopsy (SLNB); Reoperation; ICG (indocyanine Green)
• Intervention / Treatment: Procedure: Identification rate of sentinel lymph node

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: SEEYOUN LEE; Phone Number: +82-31-920-1736

Study Locations

• Korea, Republic of
  • Goyang-si, Korea, Republic of
    • Recruiting
    • National Cancer Center
    • Contact: SEEYOUN LEE; Phone Number: +82-31-920-1736; Email: seeyoun@ncc.re.kr
    • Contact: SEEYOUN LEE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients with ipsilateral locally recurrent breast cancer who previously underwent ipsilateral axillary surgery.
• Female patients aged 18 years or older.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patients who voluntarily decide to participate in the study and provide written informed consent.

Exclusion Criteria:

• Patients with distant metastases.
• Patients who previously underwent ipsilateral mastectomy.
• Pregnant or breastfeeding women.
• Patients with a general condition that impairs the ability to understand or provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radioactive Isotope (RI) with Indocyanine Green Fluorescence (ICG-F); Sentinel lymph node mapping using a combination of radioactive isotope and indocyanine green fluorescence (ICG-F)	Procedure: Identification rate of sentinel lymph node; To evaluate the identification rate of sentinel lymph nodes (SLNs). The study will compare the identification rates based on different localization techniques for SLN mapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Identification Rate of Sentinel Lymph Nodes (SLNs)	Day of Surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison of Identification Rates Based on Sentinel Lymph Node Localization Techniques	Day of Surgery

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea
• Investigators: Principal Investigator: SEEYOUN LEE, National Cancer Center, Korea

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Breast cancer; Reoperation; Locally Recurrent Breast cancer; Sentinel Lymph Node Biopsy (SLNB); ICG(indocyanine green)
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Skin Diseases; Breast Diseases; Recurrence; Breast Neoplasms
• Other Study ID Numbers: NCC-2310621-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No