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NCT04998682 | RECRUITING | Breast Cancer

Prospective Evaluation of Targeted Axillary Dissection (TAD)
Sponsor:

University of Miami

Information provided by (Responsible Party):

Susan Kesmodel, MD

Brief Summary:

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.

Condition or disease

Breast Cancer

Intervention/treatment

Axillary Dissection

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 45 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : TAD: Prospective Evaluation of Targeted Axillary Dissection After Neoadjuvant Systemic Therapy in Patients with Breast Cancer with Advanced Nodal Disease At Diagnosis
Actual Study Start Date : 2022-03-01
Estimated Primary Completion Date : 2026-03
Estimated Study Completion Date : 2026-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Prospective Evaluation of Targeted Axillary Dissection (TAD)

Location Details

NCT04998682

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Locations

RECRUITING

United States, Florida

University of Miami

Miami, Florida, United States, 33136