Breast CancerTADNCT04998682
Prospective Evaluation of Targeted Axillary Dissection (TAD)
A study testing Axillary Dissection in people with Breast Cancer, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Axillary Dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 11 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- History of allergic reactions or hypersensitivity to radioactive lymph node mapping agents or blue dye.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TAD: Prospective Evaluation of Targeted Axillary Dissection After Neoadjuvant Systemic Therapy in Patients With Breast Cancer With Advanced Nodal Disease at Diagnosis
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.
- Conditions
- Breast Cancer
- Being tested
- Axillary Dissection
- Keywords
- Targeted Axillary Dissection, Advanced Nodal Disease, Axillary Lymph Node
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary DissectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Targeted Axillary Dissection (TAD) | Experimental | 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. Receives: Procedure: Axillary Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 weeks
Secondary outcomes (5)
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.
Measured: Day 1 (Day of Surgery)
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.
Measured: Day 1 (Day of Surgery)
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.
Measured: Up to 2 weeks
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.
Measured: Up to 2 weeks
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.
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start1 Mar 2022
- Primary completion11 Feb 2026
- Study completion11 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Kesmodel, MD, University of Miami
- Investigators
- Susan Kesmodel, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998682
- Sponsor's protocol ID
- 20201540
- Other IDs
- NCI-2021-11060
- Acronym
- TAD
- Status last verified
- Feb 2026
- First submitted
- 7 Aug 2021
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAD: Prospective Evaluation of Targeted Axillary Dissection After Neoadjuvant Systemic Therapy in Patients With Breast Cancer With Advanced Nodal Disease at Diagnosis
- ClinicalTrials.gov ID
- NCT04998682
- Acronym / sponsor ID
- TAD / 20201540
- Conditions
- Breast Cancer
- Keywords
- Targeted Axillary Dissection, Advanced Nodal Disease, Axillary Lymph Node
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted Axillary Dissection (TAD) | Experimental | Procedure: Axillary DissectionDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
- Patients must have biopsy proven involvement of the axillary lymph nodes.
- Receipt of standard multiagent chemotherapy +/- targeted therapy based on tumor subtype.
Key exclusion criteria (2 listed)
- History of allergic reactions or hypersensitivity to radioactive lymph node mapping agents or blue dye.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axillary DissectionA surgical procedure that opens the armpit (axilla) to identify, examine, or remove lymph nodes. Axillary dissection will be performed during SoC breast cancer surgery. | Procedure or surgery | Targeted Axillary Dissection (TAD) |
Primary outcome
False Negative Rate
Time frame: Up to 2 weeks
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.
5 secondary outcomes
Sentinel Lymph Node Identification Rate
Time frame: Day 1 (Day of Surgery)
Clipped Lymph Node Identification Rate
Time frame: Day 1 (Day of Surgery)
Accuracy Rate of Imaging Studies
Time frame: Up to 2 weeks
Pathologic Complete Response (pCR)
Time frame: Up to 2 weeks
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Kesmodel, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axillary Dissection in people with Breast Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
False Negative Rate (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.