Prospective Evaluation of Targeted Axillary Dissection (TAD)
NCT ID: NCT04998682
Last Updated: 2025-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2022-03-01
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy.
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Susan Kesmodel, MD
Associate Professor of Clinical
Principal Investigators
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Susan Kesmodel, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2021-11060
Identifier Type: REGISTRY
Identifier Source: secondary_id
20201540
Identifier Type: -
Identifier Source: org_study_id
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