Assessing Sentinel Lymph Node Biopsy for Recurrent Breast Cancer
RENATA Study: Reoperative Sentinel Lymph Node Biopsy in Patients With Recurrent Ipsilateral Breast Cancer and Prior Axillary Surgical Techniques and Approaches
This study is testing how well a specific type of lymph node biopsy works for people with recurrent breast cancer on the same side as their previous surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 97 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06329089 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of sentinel lymph node biopsy in patients with recurrent breast cancer on the same side as previous surgeries. It will assess the identification rate of sentinel lymph nodes and explore drainage pathways in patients with varying histories of axillary surgeries. Participants will undergo the biopsy as part of their treatment, alongside standard surgical and adjuvant therapies. The study will involve prospective multicentric data collection from eligible patients diagnosed with ipsilateral recurrent breast cancer.
Who should consider this trial
Good fit: Ideal candidates are patients over 18 years old with ipsilateral local recurrence of breast cancer and a history of previous axillary surgery.
Not a fit: Patients with confirmed axillary metastasis, inflammatory carcinoma, or suspected distant metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for patients with recurrent breast cancer by enhancing the understanding of lymphatic drainage and sentinel lymph node identification.
How similar studies have performed: While similar approaches have been explored, this specific focus on recurrent breast cancer and sentinel lymph node biopsy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients \>18 years old with ipsilateral local recurrence of breast cancer with clinical stage cT1-3 cN0 confirmed by histology, with a history of previous axillary surgery (both sentinel lymph node biopsy and lymphadenectomy). Exclusion Criteria: * Patients with confirmed axillary metastasis (histology/immunohistochemistry) * Inflammatory carcinoma * Patients with suspected or confirmed distant metastasis on staging studies * Inability to perform the sentinel lymph node biopsy technique: allergy to radiotracer, mobility limitation
Where this trial is running
Barcelona
- Hospital Clínic de Barcelona — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Ines Torras, MD
- Email: itorras@clinic.cat
- Phone: 93 227 54 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.