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

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.

Study Overview

• Status: Recruiting
• Conditions: Mastectomy
• Intervention / Treatment: Procedure: reSLNB arm

• Study Type: Interventional
• Enrollment (Estimated): 532
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Soong June Bae, M.D.; Phone Number: 82-2-2019-4401; Email: mission815815@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06273
    • Recruiting
    • Gangnam Severance Hospital, Yonsei University College of Medicine
    • Contact: Soong June Bae, M.D.; Phone Number: 82-2-2019-4401; Email: mission815815@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

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

5) Pregnant and lactating patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5 year disease free survival	To prove non-inferiority of re-SLNB compared to ALND regarding disease free survival	5 years after surgery (re-SLNB)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
identification rate of sentinel lymph node	identification rate of sentinel lymph node	5 years after surgery
5-year overall survival	5-year overall survival	5 years after surgery
5-year local recurrence free survival	5-year local recurrence free survival	5 years after surgery
5-year regional recurrence free survival	5-year regional recurrence free survival	5 years after surgery
5-year distant metastasis free survival	5-year distant metastasis free survival	5 years after surgery
survival by adjuvant treatment	survival analysis according to the adjuvant treatment after secondary surgery	5 years after surgery
survival by tumor subtype	survival analysis by tumor subtype	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)	5 years after surgery
5-year DFS by tumor location	5-year DFS accoridng to the location of primary tumor (caudal/non-caudal)	5 years after surgery

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital
• Investigators: Principal Investigator: Joon Jeong, Gangnam Severance Hospital, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Breast cancer, Recurrence, Sentinel lymph node biopsy
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Breast Diseases; Breast Neoplasms; Recurrence
• Other Study ID Numbers: 3-2020-0448

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No