NCT04741737

Repeat Sentinel Lymph Node Biopsy in Ipsilateral Breast Tumor Recurrence

Repeat Sentinel Lymph Node Biopsy in Ipsilateral Breast Tumor Recurrence Without Distant Metastasis: A Single-arm, Multicenter, Prospective Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 532 (estimated)
• Sponsor: Gangnam Severance Hospital · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mastectomy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-03-01
• Primary completion: 2024-01-31
• Completion: 2029-01-31
• First posted: 2021-02-05
• Last updated: 2023-10-11

Locations

1 site across 1 country: South Korea