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Prospective Evaluation of Targeted Axillary Dissection (TAD)

Prospective Evaluation of Targeted Axillary Dissection (TAD)

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

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.

Study details
    Breast Cancer

NCT04998682

University of Miami

26 January 2024

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