Status:
RECRUITING
Repeat Sentinel Lymph Node Biopsy in Ipsilateral Breast Tumor Recurrence
Lead Sponsor:
Gangnam Severance Hospital
Conditions:
Mastectomy
Eligibility:
FEMALE
19+ years
Phase:
NA
Brief Summary
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 perfo...
Eligibility Criteria
Inclusion
- Age over 19 years old
- Patients who are expected to undergo surgery under the diagnosis of ipsilateral breast tumor recurrence(histologically confirmed in situ disease or invasive disease)
- Patients who had partial mastectomy and sentinel lymph node biopsy for prior operation for the initially diagnosed breast cancer
- Patients considered to be axillary lymph node negative from clinical findings
- Patients who understand and willingly participate in the study
Exclusion
- Patients with recurrence in other regions. (e.g. ipsilateral axillary lymph node, supraclavicular lymph node, internal mammary lymph node, etc.)
- Patients who are not eligible to perform SLNB
- Patients who received mastectomy or axillary lymph node dissection for prior operation
- Patients who experienced recurrence within a year from the primary operation
- Patientes who are known to have axillary lymph node metastasis before the secondary operation, histologically confirmed from tissue biopsy or cytology
- Patients with systemic recurrence
- Patients with inflammatory breast cancer
- 5\) Pregnant and lactating patients
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2029
Estimated Enrollment :
532 Patients enrolled
Trial Details
Trial ID
NCT04741737
Start Date
March 1 2020
End Date
January 31 2029
Last Update
October 11 2023
Active Locations (1)
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1
Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea, 06273