Prospective Evaluation of Targeted Axillary Dissection (TAD)

Description

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

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Study Overview

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Study Details

Study 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.

TAD: Prospective Evaluation of Targeted Axillary Dissection After Neoadjuvant Systemic Therapy in Patients With Breast Cancer With Advanced Nodal Disease at Diagnosis

Prospective Evaluation of Targeted Axillary Dissection (TAD)

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami, Miami, Florida, United States, 33136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * History of allergic reactions or hypersensitivity to radioactive lymph node mapping agents or blue dye.
  • * Pregnancy.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Miami,

Susan Kesmodel, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

2025-03