Prospective Evaluation of Targeted Axillary Dissection (TAD) (TAD)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Axillary Dissection

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Targeted Axillary Dissection (TAD); 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.	Procedure: Axillary Dissection; A surgical procedure that opens the armpit (axilla) to identify, examine, or remove lymph nodes. Axillary dissection will be performed during SoC breast cancer surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
False Negative Rate	The false negative rate of targeted axillary dissection after neoadjuvant systemic therapy (NST) in study participants. A false negative event will be defined as a case where the specific node (either the clipped node or the sentinel lymph node, depending on the analysis) does not show metastasis even though residual disease is identified in the other axillary nodes. The false negative rate will be computed as the number of false negative events divided by the total number of pathologically node-positive patients.	Up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sentinel Lymph Node Identification Rate	The sentinel lymph node identification rate is the number of study participants with at least one sentinel lymph node divided by total number of study participants.	Day 1 (Day of Surgery)
Clipped Lymph Node Identification Rate	The clipped lymph node identification rate is the number of study participants with at least one clipped lymph node removed divided by the total number of study participants with clipped lymph nodes.	Day 1 (Day of Surgery)
Accuracy Rate of Imaging Studies	The accuracy rate of imaging studies in determining response in the breast and axilla will be calculated as the sum of true responders on imaging and true non-responders on imaging divided by total number of study participants.	Up to 2 weeks
Pathologic Complete Response (pCR)	The number of participants with pCR will be reported. The percentage of patients with pCR will be calculated as the number of patients with a pCR divided by the total number of study participants. PCR is defined as the lack of all signs of cancer in tissue samples removed during surgery.	Up to 2 weeks
Incidence of Treatment-Emergent Adverse Events	Number of participants experiencing treatment-emergent adverse events (AEs). AEs will be assessed by and assigned severity and treatment attribution by the treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.	Up to 3 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Susan Kesmodel, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): February 11, 2026
• Study Completion (Actual): February 11, 2026

Study Registration Dates

• First Submitted: August 7, 2021
• First Submitted That Met QC Criteria: August 7, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Targeted Axillary Dissection; Advanced Nodal Disease; Axillary Lymph Node
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 20201540; NCI-2021-11060 (Registry Identifier: NCI Clinical Trials Reporting Program (NCI CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No