Clinical trial Recruiting at 1 site Interventional Ages 19 and up Women only

Repeat Sentinel Lymph Node Biopsy for Breast Cancer Recurrence

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

Run by Gangnam Severance Hospital · NCT04741737 · Data updated 2026-11-12

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

Study typeInterventional
Ages19 Years and up
SexWomen only
Enrollment532 (estimated)
SponsorGangnam Severance Hospital
Academic / other
Drugs / interventionsradiation
Locations1 site (Seoul)
StatusRecruiting
StartedMarch 1, 2020
Main results expectedJanuary 31, 2024
Study endsJanuary 31, 2029
Registry record updatedOctober 11, 2023
Trial IDNCT04741737 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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.
  • Email: mission815815@yuhs.ac
  • Phone: 82-2-2019-4401

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.