Repeat Sentinel Lymph Node Biopsy in Ipsilateral Breast Tumor Recurrence
Primary Purpose
Mastectomy
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
reSLNB arm
Sponsored by
About this trial
This is an interventional treatment trial for Mastectomy focused on measuring Breast cancer, Recurrence, Sentinel lymph node biopsy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Gangnam Severance Hospital, Yonsei University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
reSLNB arm
Arm Description
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 for primary operation.
Outcomes
Primary Outcome Measures
5 year disease free survival
To prove non-inferiority of re-SLNB compared to ALND regarding disease free survival
Secondary Outcome Measures
identification rate of sentinel lymph node
identification rate of sentinel lymph node
5-year overall survival
5-year overall survival
5-year local recurrence free survival
5-year local recurrence free survival
5-year regional recurrence free survival
5-year regional recurrence free survival
5-year distant metastasis free survival
5-year distant metastasis free survival
survival by adjuvant treatment
survival analysis according to the adjuvant treatment after secondary surgery
survival by tumor subtype
survival analysis by tumor subtype
identification rate of sentinel lymph node by tumor location
identification rate of sentinel lymph node according to the location of primary tumor(caudal/non-caudal)
5-year DFS by tumor location
5-year DFS accoridng to the location of primary tumor (caudal/non-caudal)
Full Information
NCT ID
NCT04741737
First Posted
January 28, 2021
Last Updated
October 9, 2023
Sponsor
Gangnam Severance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04741737
Brief Title
Repeat Sentinel Lymph Node Biopsy in Ipsilateral Breast Tumor Recurrence
Official Title
Repeat Sentinel Lymph Node Biopsy in Ipsilateral Breast Tumor Recurrence Without Distant Metastasis: A Single-arm, Multicenter, Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastectomy
Keywords
Breast cancer, Recurrence, Sentinel lymph node biopsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
532 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
reSLNB arm
Arm Type
Experimental
Arm Description
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 for primary operation.
Intervention Type
Procedure
Intervention Name(s)
reSLNB arm
Intervention Description
Radioisotope, blue dye, dual mapping methods are all allowed for re-SLNB mapping. Positive finding in re-SLNB is defined according to AJCC 8th edition, as micrometastasis or macrometastasis. Isolated tumor cell is considered negative. When sentinel lymph node is not identified, axillary operation is via physician's choice. When re-SLNB finding is negative, no further axillary lymph node dissection is performed. If there is node metastasis from re-SLNB, axillary lymph node dissection or radiation therapy can be performed as in physician's choice.
Primary Outcome Measure Information:
Title
5 year disease free survival
Description
To prove non-inferiority of re-SLNB compared to ALND regarding disease free survival
Time Frame
5 years after surgery (re-SLNB)
Secondary Outcome Measure Information:
Title
identification rate of sentinel lymph node
Description
identification rate of sentinel lymph node
Time Frame
5 years after surgery
Title
5-year overall survival
Description
5-year overall survival
Time Frame
5 years after surgery
Title
5-year local recurrence free survival
Description
5-year local recurrence free survival
Time Frame
5 years after surgery
Title
5-year regional recurrence free survival
Description
5-year regional recurrence free survival
Time Frame
5 years after surgery
Title
5-year distant metastasis free survival
Description
5-year distant metastasis free survival
Time Frame
5 years after surgery
Title
survival by adjuvant treatment
Description
survival analysis according to the adjuvant treatment after secondary surgery
Time Frame
5 years after surgery
Title
survival by tumor subtype
Description
survival analysis by tumor subtype
Time Frame
5 years after surgery
Title
identification rate of sentinel lymph node by tumor location
Description
identification rate of sentinel lymph node according to the location of primary tumor(caudal/non-caudal)
Time Frame
5 years after surgery
Title
5-year DFS by tumor location
Description
5-year DFS accoridng to the location of primary tumor (caudal/non-caudal)
Time Frame
5 years after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soong June Bae, M.D.
Phone
82-2-2019-4401
Email
mission815815@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon Jeong
Organizational Affiliation
Gangnam Severance Hospital, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangnam Severance Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soong June Bae, M.D.
Phone
82-2-2019-4401
Email
mission815815@yuhs.ac
12. IPD Sharing Statement
Learn more about this trial
Repeat Sentinel Lymph Node Biopsy in Ipsilateral Breast Tumor Recurrence
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