Actively Recruiting
Repeat Sentinel Lymph Node Biopsy in Ipsilateral Breast Tumor Recurrence
Led by Gangnam Severance Hospital · Updated on 2023-10-11
532
Participants Needed
1
Research Sites
465 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
According to the standard treatment guidelines established until recently, in the case of ipsilateral breast tumor recurrence without systemic metastasis, salvage mastectomy or lumpectomy can be performed when either partial or whole breast radiation therapy is possible. On the other hand, there are currently no standard treatment guidelines for axillary treatment, and the evidence for this is limited. Axillary lymph node metastasis was reported to occur in about 26% of breast cancer patients who had negative sentinel lymph nodes from previous surgery for primary breast cancer and only local recurrence occurred. It is still important in the decision of treatment or adjuvant radiation therapy. However, it is known that most of the patients with ipsilateral breast recurrence do not have axillary lymph node metastasis. Therefore, performing axillary axillary surgery in all of these patients does not help the patient's survival in many cases, but rather can lead to complications such as lymphedema and seroma and postoperative wound infection. A question about the implementation of axillary lymph node resection has been raised and for this reason, it is necessary to study whether surveillance lymph node biopsy is still effective in patients with recurrence in the ipsilateral breast. Most of the studies on ipsilateral breast tumor recurrence without systemic metastasis reported to date are case reports or small retrospective studies. In addition, the combined meta-analysis also has limitations in that the study design is not uniform, and there are many cases in which primary breast cancer surgery performed total mastectomy or axillary lymph node dissection. This study is a multicenter prospective study designed to validate the clinical effectiveness of repeat-SLNB conducted in patients with ipsilateral breast tumor recurrence among patients who previously underwent breast conservation and sentinel lymph node biopsy for unilateral primary breast cancer.
CONDITIONS
Official Title
Repeat Sentinel Lymph Node Biopsy in Ipsilateral Breast Tumor Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 19 years old
- Diagnosed with ipsilateral breast tumor recurrence confirmed by tissue analysis
- Previously underwent partial mastectomy and sentinel lymph node biopsy for initial breast cancer
- Clinically assessed as having no axillary lymph node metastasis
- Willing and able to provide informed consent to participate in the study
You will not qualify if you...
- Recurrence in other regions such as ipsilateral axillary, supraclavicular, or internal mammary lymph nodes
- Not eligible for sentinel lymph node biopsy
- Previous mastectomy or axillary lymph node dissection for initial breast cancer
- Recurrence occurring within one year of the primary surgery
- Known axillary lymph node metastasis confirmed by biopsy or cytology before the study surgery
- Presence of systemic recurrence
- Diagnosis of inflammatory breast cancer
- Currently pregnant or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea, 06273
Actively Recruiting
Research Team
S
Soong June Bae, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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