repeat sentinel lymph node biopsy in patients with breast tumor recurrence

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0005856
• Lead Sponsor: Yonsei University Health System, Gangnam Severance Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 23 February 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 532

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
8) Pregnant and lactating patients

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5-year disease free survival

Secondary Outcome Measures

Name	Time	Method
identification rate of sentinel lymph node;5-year overall survival;5-year local recurrence free survival;5-year regional recurrence free survival;5-year distant metastasis free survival;survival analysis according to the adjuvant treatment after secondary surgery;survival analysis by tumor subtype;identification rate of sentinel lymph node according to the location of primary tumor(caudal/non-caudal);5-year DFS accoridng to the location of primary tumor (caudal/non-caudal)