Prospective Evaluation of Targeted Axillary Dissection (TAD)

University of Miami

Status: Enrolling

Conditions: Breast Cancer

Treatments: Procedure: Axillary Dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT04998682

20201540

NCI-2021-11060 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Targeted Axillary Dissection (TAD)

Experimental group

Description:

During standard of care (SoC) surgery to remove breast cancer, study participants will undergo a sampling of lymph nodes in the axilla first and then complete removal of axillary lymph nodes under the arm.

Treatment:

Procedure: Axillary Dissection