Breast CancerPhase 2NCT06780748
Photo-medicine-Guided Dual Approach for Reoperation of Sentinel Lymph Nodes in Locally Recurrent Breast Cancer Patients
A Phase 2 study testing Identification rate of sentinel lymph node in people with Breast Cancer and Locally Recurrent Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Locally Recurrent Breast Cancer, Sentinel Lymph Node Biopsy (SLNB)
- What is being tested?
- Identification rate of sentinel lymph node
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Aug 2023to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
SEEYOUN LEE contact
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si
SEEYOUN LEE, +82-31-920-1736, seeyoun@ncc.re.kr
SEEYOUN LEE
About this study
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.
Read more
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.
- Conditions
- Breast Cancer, Locally Recurrent Breast Cancer, Sentinel Lymph Node Biopsy (SLNB), Reoperation, ICG (indocyanine Green)
- Being tested
- Identification rate of sentinel lymph node
- Keywords
- Breast cancer, Locally Recurrent Breast cancer, Sentinel Lymph Node Biopsy (SLNB), Reoperation, ICG(indocyanine green)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification rate of sentinel lymph nodeProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Radioactive Isotope (RI) with Indocyanine Green Fluorescence (ICG-F) | Experimental | Sentinel lymph node mapping using a combination of radioactive isotope and indocyanine green fluorescence (ICG-F) Receives: Procedure: Identification rate of sentinel lymph node |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification Rate of Sentinel Lymph Nodes (SLNs)
Measured: Day of Surgery
Secondary outcomes (1)
Comparison of Identification Rates Based on Sentinel Lymph Node Localization Techniques
Measured: Day of Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start13 Aug 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Seeyoun Lee, National Cancer Center, Korea
- Investigators
- SEEYOUN LEE, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780748
- Sponsor's protocol ID
- NCC-2310621-2
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photo-medicine-Guided Dual Approach for Reoperation of Sentinel Lymph Nodes in Locally Recurrent Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06780748
- Acronym / sponsor ID
- NCC-2310621-2
- Conditions
- Breast Cancer, Locally Recurrent Breast Cancer, Sentinel Lymph Node Biopsy (SLNB), Reoperation, ICG (indocyanine Green)
- Keywords
- Breast cancer, Locally Recurrent Breast cancer, Sentinel Lymph Node Biopsy (SLNB), Reoperation, ICG(indocyanine green)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 13 Aug 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radioactive Isotope (RI) with Indocyanine Green Fluorescence (ICG-F) | Experimental | Procedure: Identification rate of sentinel lymph nodeSentinel lymph node mapping using a combination of radioactive isotope and indocyanine green fluorescence (ICG-F) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identification rate of sentinel lymph nodeTo evaluate the identification rate of sentinel lymph nodes (SLNs). The study will compare the identification rates based on different localization techniques for SLN mapping | Procedure or surgery | Radioactive Isotope (RI) with Indocyanine Green Fluorescence (ICG-F) |
Primary outcome
Identification Rate of Sentinel Lymph Nodes (SLNs)
Time frame: Day of Surgery
1 secondary outcome
Comparison of Identification Rates Based on Sentinel Lymph Node Localization Techniques
Time frame: Day of Surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SEEYOUN LEE contact
SEEYOUN LEE principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Identification rate of sentinel lymph node in people with Breast Cancer and Locally Recurrent Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SEEYOUN LEE (+82-31-920-1736), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification Rate of Sentinel Lymph Nodes (SLNs) (time frame: Day of Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.