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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Gangnam Severance Hospital, Yonsei University College of Medicine
RECRUITING
Seoul
Contact Information
Primary
Soong June Bae, M.D.
mission815815@yuhs.ac
82-2-2019-4401
Time Frame
Start Date: 2020-03-01
Estimated Completion Date: 2029-01-31
Participants
Target number of participants: 532
Treatments
Experimental: reSLNB arm
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.
Related Therapeutic Areas
Sponsors
Leads: Gangnam Severance Hospital

This content was sourced from clinicaltrials.gov