Prospective Evaluation of Targeted Axillary Dissection (TAD)
United States20 participantsStarted 2022-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.