NCT06780748 Photo-medicine-Guided Dual Approach for Reoperation of Sentinel Lymph Nodes in Locally Recurrent Breast Cancer Patients
| NCT ID | NCT06780748 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National Cancer Center, Korea |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-08-13 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2023-08-13 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
SEEYOUN LEE
📞 +82-31-920-1736
SEEYOUN LEE
PRINCIPAL INVESTIGATOR
National Cancer Center, Korea
Frequently Asked Questions
Who can join the NCT06780748 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06780748 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06780748 currently recruiting?
Yes, NCT06780748 is actively recruiting participants. Visit ClinicalTrials.gov or contact National Cancer Center, Korea to inquire about joining.
Where is the NCT06780748 trial being conducted?
This trial is being conducted at Goyang-si, South Korea.
Who is sponsoring the NCT06780748 clinical trial?
NCT06780748 is sponsored by National Cancer Center, Korea. The principal investigator is SEEYOUN LEE at National Cancer Center, Korea. The trial plans to enroll 30 participants.
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