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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Contact Information
Primary
Maynela Quinones Mendez
maynela@med.miami.edu
(305) 243-2457
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2026-03
Participants
Target number of participants: 45
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Miami

This content was sourced from clinicaltrials.gov