Clinical trial · Observational
Reoperative Sentinel Lymph Node Biopsy in Patients With Recurrent Ipsilateral Breast Cancer
RENATA Study: Reoperative Sentinel Lymph Node Biopsy in Patients With Recurrent Ipsilateral Breast Cancer and Prior Axillary Surgical Techniques and Approaches
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to assess the effectiveness of sentinel lymph node biopsy as a treatment approach for patients with recurrent breast cancer on the same side as previous surgeries. The main questions it aims to answer are: * What is the rate of identification of the sentinel lymph node, and how does it vary among patients with different histories of axillary surgeries? * How can we describe and understand the drainage pathways, including those from the armpit on the same side as the cancer, the area near the breastbone, and the opposite armpit? Participants will undergo sentinel lymph node biopsy as part of their treatment for recurrent breast cancer. They will also receive standard treatments, including surgery and adjuvant therapies as recommended by their healthcare team.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Reoperative Sentinel Lymph Node Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Recurrent ipsilateral breast cancer
- description
- Recurrent ipsilateral breast cancer refers to the return of breast cancer in the same breast where it originally developed or was treated.
- interventionNames
- Procedure: Reoperative Sentinel Lymph Node Biopsy
Primary outcomes (2)
- measure
- Re-Sentinel Lymph node harvesting rate
- timeFrame
- 12 months
- description
- Calculation of SLN identification rate and analysis of subgroups based on previous axillary surgery.
- measure
- Drainage pathways description
- timeFrame
- 12 months
- description
- Describe and study the drainage pathways including the ipsilateral axilla, the internal mammary chain, and the contralateral axilla
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available