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Procedure
Targeted Axillary Dissection for Breast Cancer (TAD Trial)
N/A
Recruiting
Led By Susan Kesmodel, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have biopsy proven involvement of the axillary lymph nodes
Receipt of standard multiagent chemotherapy +/- targeted therapy based on tumor subtype
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 weeks
Awards & highlights
TAD Trial Summary
This trial is testing whether a less invasive way of removing lymph nodes from people with breast cancer is just as effective as the standard method.
Who is the study for?
This trial is for adults with invasive adenocarcinoma of the breast, who have certain levels of axillary lymph node involvement and are candidates for surgery. They must have completed standard chemotherapy +/- targeted therapy and not be pregnant or allergic to specific mapping agents used in the study.Check my eligibility
What is being tested?
The study is testing a procedure called Targeted Axillary Dissection (TAD) to see if sampling fewer lymph nodes can effectively manage cancer spread in patients with breast cancer, instead of removing more nodes which has been common practice.See study design
What are the potential side effects?
Potential side effects may include pain, swelling, limited arm movement, infection risk at the surgical site, and possibly lymphedema (swelling due to lymph fluid build-up) as these are common risks associated with axillary dissection surgeries.
TAD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My biopsy shows cancer in my axillary lymph nodes.
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I have received standard chemotherapy, with or without targeted therapy, based on my cancer type.
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I am eligible for breast cancer surgery.
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My cancer was at an early to advanced stage but hadn't spread to distant organs when diagnosed.
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My breast cancer is confirmed to be invasive adenocarcinoma.
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My underarm lymph nodes are hard and stuck together.
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My scans show advanced cancer in the lymph nodes near my collarbone and chest.
TAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
False Negative Rate
Secondary outcome measures
Accuracy Rate of Imaging Studies
Clipped Lymph Node Identification Rate
Incidence of Treatment-Emergent Adverse Events
+2 moreTAD Trial Design
1Treatment groups
Experimental Treatment
Group I: Targeted Axillary Dissection (TAD)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axillary Dissection
2007
N/A
~360
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
900 Previous Clinical Trials
409,887 Total Patients Enrolled
16 Trials studying Breast Cancer
1,506 Patients Enrolled for Breast Cancer
Susan Kesmodel, MDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
5 Total Patients Enrolled
1 Trials studying Breast Cancer
5 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer's spread to nearby lymph nodes was checked by physical exam and scans.My biopsy shows cancer in my axillary lymph nodes.I have received standard chemotherapy, with or without targeted therapy, based on my cancer type.I am eligible for breast cancer surgery.My cancer was at an early to advanced stage but hadn't spread to distant organs when diagnosed.I am 18 years old or older.My breast cancer is confirmed to be invasive adenocarcinoma.My underarm lymph nodes are hard and stuck together.My scans show advanced cancer in the lymph nodes near my collarbone and chest.You have had allergic reactions to radioactive lymph node mapping agents or blue dye in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Targeted Axillary Dissection (TAD)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial offer opportunities to participate at the moment?
"Clinicaltrials.gov states that this research study is actively seeking participants, which was first publicised on March 1st 2022 and recently modified on the 23rd of the same month."
Answered by AI
What is the sample size of participants for this research project?
"That is correct. According to clinicaltrials.gov, this medical trial was posted on the 1st of March 2022 and has since been re-opened for recruitment with an update occurring on the 23rd of March. 45 candidates are being sought at one particular site."
Answered by AI
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