Prospective Evaluation of Targeted Axillary Dissection (TAD)

Breast Cancer Clinical Trial

— TAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04998682
• Other study ID #: 20201540
• Secondary ID: NCI-2021-11060
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: Jornan Rodriguez Leyva
• Phone: 305-243-2871
• Email: jxr1312[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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