Repeat Sentinel Lymph Node Biopsy in Ipsilateral Breast Tumor Recurrence

Mastectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04741737
• Other study ID #: 3-2020-0448
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: January 31, 2029

Study information

• Verified date: October 2023
• Source: Gangnam Severance Hospital
• Contact: Soong June Bae, M.D.
• Phone: 82-2-2019-4401
• Email: mission815815[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 532
• Est. completion date: January 31, 2029
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Mastectomy
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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