Reoperative Sentinel Lymph Node Biopsy in Patients With Recurrent Ipsilateral Breast Cancer

NCT06329089 | Recruiting

• 1 other identifier: HCB/2023/0840
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Re-Sentinel Lymph node harvesting rate

  Calculation of SLN identification rate and analysis of subgroups based on previous axillary surgery.

  12 months

• Drainage pathways description

  Describe and study the drainage pathways including the ipsilateral axilla, the internal mammary chain, and the contralateral axilla

  12 months

Secondary Outcomes (4)

• Complications rate

  12 months

• Axillary metastasis rate

  12 months

• Correlation Between Axillary and Internal Mammary Chain Infiltration

  12 months

• Quality of life in recurrent breast cancer

  12 months

Study Arms (1)

Recurrent ipsilateral breast cancer

Recurrent ipsilateral breast cancer refers to the return of breast cancer in the same breast where it originally developed or was treated.

Procedure: Reoperative Sentinel Lymph Node Biopsy

Interventions

Reoperative Sentinel Lymph Node Biopsy PROCEDURE

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.

Recurrent ipsilateral breast cancer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population comprises individuals who are over 18 years old and have been diagnosed with ipsilateral local recurrence of breast cancer, confirmed histologically with tumor sizes ranging from clinical stage cT1 to cT3. These patients must have a history of prior axillary surgery, including both sentinel lymph node biopsy and lymphadenectomy. Exclusion from the study includes patients with confirmed axillary metastasis, diagnosed inflammatory carcinoma, or suspected or confirmed distant metastasis based on staging studies. Additionally, individuals unable to undergo sentinel lymph node biopsy due to allergies to the radiotracer or mobility limitations are excluded from participation.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ines Torras, MD

CONTACT

93 227 54 00; itorras@clinic.cat

Eduard Mension, MD PhD

CONTACT

93 227 54 00; mension@clinic.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)