An interventional study of reSLNB arm in Mastectomy, sponsored by Gangnam Severance Hospital. Recruiting at 1 site in Korea, Republic of. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-10-11.
Sponsored by Gangnam Severance Hospital · Not applicable, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 532 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Gangnam Severance Hospital is the lead sponsor of 141 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
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.
Procedure: reSLNB arm
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.
5 year disease free survival
To prove non-inferiority of re-SLNB compared to ALND regarding disease free survival
Time frame: 5 years after surgery (re-SLNB)
identification rate of sentinel lymph node
identification rate of sentinel lymph node
Time frame: 5 years after surgery
5-year overall survival
5-year overall survival
Time frame: 5 years after surgery
5-year local recurrence free survival
5-year local recurrence free survival
Time frame: 5 years after surgery
5-year regional recurrence free survival
5-year regional recurrence free survival
Time frame: 5 years after surgery
5-year distant metastasis free survival
5-year distant metastasis free survival
Time frame: 5 years after surgery
survival by adjuvant treatment
survival analysis according to the adjuvant treatment after secondary surgery
Time frame: 5 years after surgery
survival by tumor subtype
survival analysis by tumor subtype
Time frame: 5 years after surgery
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)
Time frame: 5 years after surgery
5-year DFS by tumor location
5-year DFS accoridng to the location of primary tumor (caudal/non-caudal)
Time frame: 5 years after surgery
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Gangnam Severance Hospital