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 type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | Women only |
| Enrollment | 532 (estimated) |
| Sponsor | Gangnam Severance Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | March 1, 2020 |
| Main results expected | January 31, 2024 |
| Study ends | January 31, 2029 |
| Registry record updated | October 11, 2023 |
| Trial ID | NCT04741737 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.
-
Reverse Fly Exercise for Supraspinatus Tendinitis in Women on Aromatase Inhibitors After Mastectomy
This study tests whether adding reverse fly exercises to standard tendonitis therapy helps relief in women aged 50–70 who had mastectomy and are on aromatase inhibitors.
-
Transverse vs Longitudinal Serratus Anterior Plane Block for Breast Surgery
This trial tests whether a longitudinal ultrasound view for serratus anterior plane block provides better pain relief after breast surgery than the standard transverse view.
-
Combined PECS II and PIP blocks vs TPVB for post-mastectomy pain relief
This trial tests whether a combination of PECS II and superficial PIP blocks can provide better or similar pain relief after mastectomy compared with the standard thoracic paravertebral block.
-
Erector Spinae Block vs Paravertebral Block for Chronic Pain After Mastectomy
This trial tests whether an erector spinae block can better prevent chronic pain after mastectomy than a paravertebral block in adults 18–80.
-
Same-day awake mastectomy with immediate prepectoral implant reconstruction
This project tests whether the AMADeuS care pathway—awake same-day mastectomy with prepectoral implant reconstruction, opioid-sparing anesthesia, and telemedicine follow-up—controls pain and is as safe as usual hospital care for women having mastectomy.
-
Comparing two ultrasound-guided chest wall nerve blocks for pain after mastectomy
This study will see if one of two ultrasound-guided chest wall nerve blocks gives better pain relief and less opioid use for women having an elective mastectomy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.