Prospective Evaluation of Targeted Axillary Dissection (TAD)

• Sponsor: University of Miami (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04998682
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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	Intervention/Treatment	Phase
Breast Cancer	Procedure: Axillary Dissection	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• 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: Mar 1, 2022
• Anticipated Primary Completion Date: Mar 1, 2025
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. False Negative Rate [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 Outcome Measures

1. Sentinel Lymph Node Identification Rate [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 [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 [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) [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Susan Kesmodel, MD, Associate Professor of Clinical, University of Miami
• ClinicalTrials.gov Identifier: NCT04998682
• Other Study ID Numbers: 20201540; NCI-2021-11060
• First Posted: Aug 10, 2021
• Last Update Posted: Mar 25, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Susan Kesmodel, MD, Associate Professor of Clinical, University of Miami: Targeted Axillary Dissection; Advanced Nodal Disease; Axillary Lymph Node
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Mar 25, 2022