RECRUITING

Prospective Evaluation of Targeted Axillary Dissection (TAD)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-03-01
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04998682

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women or men greater than or equal to 18 years.
  2. * Histologically confirmed invasive adenocarcinoma of the breast.
  3. * Clinical T0-4 N2-3 M0 at diagnosis (American Joint Committee on Cancer, 7th Edition)
  4. * 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.
  5. * Cross-sectional imaging will be used to identify advanced nodal disease involving the axilla, infraclavicular, supraclavicular, and internal mammary regions, cN3 disease.
  6. * Patients must have biopsy proven involvement of the axillary lymph nodes.
  7. * Receipt of standard multiagent chemotherapy +/- targeted therapy based on tumor subtype.
  8. * Candidate for surgical management of breast cancer.
  9. * Ability to understand and willingness to sign a written informed consent document.
  1. * History of allergic reactions or hypersensitivity to radioactive lymph node mapping agents or blue dye.
  2. * Pregnancy.

Contacts and Locations

Study Contact

Jornan Rodriguez Leyva
CONTACT
305-243-2871
jxr1312@miami.edu

Principal Investigator

Susan Kesmodel, MD
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

University of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Susan Kesmodel, MD, PRINCIPAL_INVESTIGATOR, University of Miami

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

Study Start Date2022-03-01
Study Completion Date2025-03

Study Record Updates

Study Start Date2022-03-01
Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

  • Targeted Axillary Dissection
  • Advanced Nodal Disease
  • Axillary Lymph Node

Additional Relevant MeSH Terms

  • Breast Cancer