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Repeat Sentinel Lymph Node Biopsy in Ipsilateral Breast Tumor Recurrence

RecruitingNAAges 19 Years - anyFemaleGangnam Severance Hospital
NCT04741737 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age over 19 years old 2. Patients who are expected to undergo surgery under the diagnosis of ipsilateral breast tumor recurrence(histologically confirmed in situ disease or invasive disease) 3. Patients who had partial mastectomy and sentinel lymph node biopsy for prior operation for the initially diagnosed breast cancer 4. Patients considered to be axillary lymph node negative from clinical findings 5. Patients who understand and willingly participate in the study Exclusion Criteria: 1. Patients with recurrence in other regions. (e.g. ipsilateral axillary lymph node, supraclavicular lymph node, internal mammary lymph node, etc.) 2. Patients who are not eligible to perform SLNB 3. Patients who received mastectomy or axillary lymph node dissection for prior operation 4. Patients who experienced recurrence within a year from the primary operation 5. Patientes who are known to have axillary lymph node metastasis before the secondary operation, histologically confirmed from tissue biopsy or cytology 6. Patients with systemic recurrence 7. Patients with inflammatory breast cancer 5\) Pregnant and lactating patients
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What it tests

  • reSLNB arm
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Where

1 site
Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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