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Completed

NCT Number: NCT04998682

Prospective Evaluation of Targeted Axillary Dissection (TAD)

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Axillary dissection

Procedure

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.

Primary outcomes

  1. False Negative Rate

    Time frame: Up to 2 weeks

    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.

Secondary outcomes

  1. Sentinel Lymph Node Identification Rate

    Time frame: Day 1 (Day of Surgery)

    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.

  2. Clipped Lymph Node Identification Rate

    Time frame: Day 1 (Day of Surgery)

    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.

  3. Accuracy Rate of Imaging Studies

    Time frame: Up to 2 weeks

    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.

  4. Pathologic Complete Response (pCR)

    Time frame: Up to 2 weeks

    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.

  5. Incidence of Treatment-Emergent Adverse Events

    Time frame: Up to 3 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Acronym: TAD

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 10, 2021
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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