RecruitingNCT06329089

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


Sponsor

Hospital Clinic of Barcelona

Enrollment

97 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria1

  • 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 Criteria4

  • 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

Interventions

PROCEDUREReoperative Sentinel Lymph Node Biopsy

Reoperative sentinel lymph node biopsy refers to a surgical procedure performed when there is a need to re-examine the sentinel lymph nodes (SLNs) in patients who have previously undergone breast cancer surgery. The sentinel lymph nodes are the first lymph nodes to which cancer cells are likely to spread from the primary tumor. During the procedure, the surgeon locates and removes the previously identified sentinel lymph nodes using techniques such as lymphatic mapping and injection of a radiotracer or dye. The removed lymph nodes are then examined by a pathologist to determine if there is any evidence of cancer spread.


Locations(1)

Hospital Clínic de Barcelona

Barcelona, Spain

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NCT06329089


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