Prospective Evaluation of Targeted Axillary Dissection (TAD)
The purpose of this research is to evaluate how to manage the axillary lymph nodes in patients with breast cancer. The investigators will determine if a sampling of the lymph nodes under the arm will give the information necessary to determine if fewer lymph nodes can be removed.
Conditions:
🦠 Breast Cancer
🗓️ Study Start (Actual) 1 March 2022
🗓️ Primary Completion (Estimated) March 2025
✅ Study Completion (Estimated) March 2025
👥 Enrollment (Estimated) 45
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Miami, Florida, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Women or men greater than or equal to 18 years.
    • * Histologically confirmed invasive adenocarcinoma of the breast.
    • * Clinical T0-4 N2-3 M0 at diagnosis (American Joint Committee on Cancer, 7th Edition)
    • * Assessment for cN2 disease will be performed by clinical exam and imaging. Patients should have pathologic level 1 and/or 2 axillary lymph nodes which are fixed/matted on physical exam.
    • * Cross-sectional imaging will be used to identify advanced nodal disease involving the axilla, infraclavicular, supraclavicular, and internal mammary regions, cN3 disease.
    • * Patients must have biopsy proven involvement of the axillary lymph nodes.
    • * Receipt of standard multiagent chemotherapy +/- targeted therapy based on tumor subtype.
    • * Candidate for surgical management of breast cancer.
    • * Ability to understand and willingness to sign a written informed consent document.

    Exclusion Criteria:

    • * History of allergic reactions or hypersensitivity to radioactive lymph node mapping agents or blue dye.
    • * Pregnancy.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 August 2021
  • First Submitted that Met QC Criteria 7 August 2021
  • First Posted 10 August 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 February 2024
  • Last Update Posted 20 February 2024
  • Last Verified February 2024