Back to resultsProspective Evaluation of Targeted Axillary Dissection (TAD) (TAD)
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Axillary Dissection
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Targeted Axillary Dissection, Advanced Nodal Disease, Axillary Lymph Node
Eligibility Criteria
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.
Sites / Locations
- University of MiamiRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Targeted Axillary Dissection (TAD)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04998682
Brief Title
Prospective Evaluation of Targeted Axillary Dissection (TAD)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Targeted Axillary Dissection, Advanced Nodal Disease, Axillary Lymph Node
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Targeted Axillary Dissection (TAD)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Axillary Dissection
Intervention Description
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 Outcome Measure Information:
Title
False Negative Rate
Description
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.
Time Frame
Up to 2 weeks
Secondary Outcome Measure Information:
Title
Sentinel Lymph Node Identification Rate
Description
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.
Time Frame
Day 1 (Day of Surgery)
Title
Clipped Lymph Node Identification Rate
Description
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.
Time Frame
Day 1 (Day of Surgery)
Title
Accuracy Rate of Imaging Studies
Description
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.
Time Frame
Up to 2 weeks
Title
Pathologic Complete Response (pCR)
Description
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.
Time Frame
Up to 2 weeks
Title
Incidence of Treatment-Emergent Adverse Events
Description
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.
Time Frame
Up to 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jornan Rodriguez Leyva
Phone
305-243-2871
Email
jxr1312@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Kesmodel, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jornan Rodriguez Leyva
Phone
305-243-2871
Email
jxr1312@miami.edu
First Name & Middle Initial & Last Name & Degree
Susan Kesmodel, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Prospective Evaluation of Targeted Axillary Dissection (TAD)
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