Repeat Sentinel Lymph Node Biopsy for Breast Cancer Recurrence

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

This study is testing if a repeat lymph node biopsy can help patients with breast cancer that has come back after treatment by giving important information for their next steps in care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 532 (estimated)
• Ages: 19 Years and up
• Sex: Female
• Sponsor: Gangnam Severance Hospital (other)
• Drugs / interventions: radiation
• Locations: 1 site (Seoul)
• Trial ID: NCT04741737 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of repeat sentinel lymph node biopsy (reSLNB) in patients experiencing ipsilateral breast tumor recurrence after initial treatment. It aims to determine whether this procedure can provide valuable information regarding axillary lymph node status, which is crucial for guiding further treatment decisions. The study focuses on patients who have previously undergone partial mastectomy and sentinel lymph node biopsy, and who are clinically assessed to be axillary lymph node negative. By evaluating the outcomes of reSLNB, the study seeks to improve treatment strategies for breast cancer recurrence.

Who should consider this trial

Good fit: Ideal candidates are women over 19 years old with a diagnosis of ipsilateral breast tumor recurrence who have previously undergone partial mastectomy and sentinel lymph node biopsy.

Not a fit: Patients with recurrence in other regions or those who have previously undergone mastectomy or axillary lymph node dissection may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more tailored and less invasive treatment options for patients with breast cancer recurrence.

How similar studies have performed: While there is limited evidence regarding the effectiveness of repeat sentinel lymph node biopsy in this context, similar approaches have shown promise in other studies.

Eligibility criteria

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

Where this trial is running

Seoul

• Gangnam Severance Hospital, Yonsei University College of Medicine — Seoul, South Korea (RECRUITING)

Study contacts

• Principal investigator: Joon Jeong — Gangnam Severance Hospital, Yonsei University College of Medicine
• Study coordinator: Soong June Bae, M.D.

Conditions: Mastectomy, Breast cancer, Recurrence, Sentinel lymph node biopsy