repeat sentinel lymph node biopsy in patients with breast tumor recurrence

Repeat sentinel lymph node biopsy in ipsilateral breast tumor recurrence without distant metastasis: A single-arm, multicenter, prospective study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005856

Enrollment

532

Registered

2021-02-03

Start date

2021-02-01

Completion date

Unknown

Last updated

2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : repeat SLNB procedure is performed in when the patient is diagnosed with ipsilateral breast tumor recurrence, who had undergone partial mastectomy and sentinel lymph node biopsy fo

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
5-year disease free survival	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

Korea, Republic of

Contacts

Public ContactJoon Jeong

Yonsei University Health System, Gangnam Severance Hospital

Outcome results