Breast Cancer by AJCC V8 Anatomic StageNCT07856160
De-escalation of Axillary Dissection for Node-positive Breast Cancer
A study testing TAD and ALND in people with Breast Cancer by AJCC V8 Anatomic Stage and Breast Cancer, run by University of Nebraska.
Trial summary
Recent studies have demonstrated the safety of de-escalation of nodal surgery for clinically node-positive breast cancer patients after a favorable response to neoadjuvant systemic therapy (NST). These studies excluded patients with clinically node-positive stage 2 or 3 (cN2, cN3) disease. Read more about this study
- Who is it for?
- Ages 19 to 99 years, women only
- Conditions the study is for
- Breast Cancer by AJCC V8 Anatomic Stage, Breast Cancer
- What is being tested?
- TAD and ALND
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 15 Nov 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females
- Aged ≥ 19 years old at time of study entry.
- Patient must be able to provide study-specific informed consent prior to study enrolment.
- Histological confirmation of breast cancer diagnosis on core needle biopsy. Pathology will be confirmed by internal UNMC review if the biopsy was completed at an outside institution.
- Clinical and/or radiographic cT1-T4 N2-3 M0 disease.
- Patients must complete NST. Patients who complete all recommended cycles of NST, regardless of dose reductions, are eligible.
- Clinical and radiographic (breast MRI with and without contrast) re-evaluation following completion of NST.
- Achievement of a complete clinical and radiographic nodal response (ycN0).
Who cannot join
- Patients with metastatic disease at presentation.
- Patients unable to complete the recommended NST.
- Patients who are pregnant.
- Patients with a known allergic reaction to injectable blue dye.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility of De-escalation of Axillary Surgery in ycN0 Breast Cancer Patients Post NAC for cN2, cN3 Disease: Evaluating the Concordance Between ypN Status From TAD and ALND
Recent studies have demonstrated the safety of de-escalation of nodal surgery for clinically node-positive breast cancer patients after a favorable response to neoadjuvant systemic therapy (NST). These studies excluded patients with clinically node-positive stage 2 or 3 (cN2, cN3) disease. Consequently, the current guidelines recommend axillary lymph node dissection (ALND) for patients with cN2/cN3 breast cancer, even after a favorable response to NST. Many cN2/cN3 patients achieve nodal pathologic complete response (pCR) after NST, and this has raised interest in less invasive surgical approaches for the management of the axilla in this setting. We aim to evaluate the pathologic concordance between lymph node status post neoadjuvant therapy (ypN) derived from targeted axillary dissection (TAD) and ALND performed sequentially under the same anesthesia in patients with cN2/cN3 who convert to clinically node-negative (ycN0) following completion of NST. If a high level of concordance is determined between the ypN status determined from the TAD and the ALND, our next step would be to expand the trial to include a larger number of patients, making it multi-institutional, in order to power the study for more meaningful analysis.
- Being tested
- TAD, ALND
- Keywords
- ALND, Sentinel Lymph Node Biopsy, TAD, Axillary, cN2, cN3
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TADProcedure or surgery
Targeted axillary dissection
ALNDProcedure or surgery
Axillary lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | TAD + ALND Receives: Procedure: TAD; Procedure: ALND |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic nodal status (ypN) derived from targeted axillary dissection (TAD) and axillary lymph node dissection (ALND.)
Pathologic concordance between pathologic nodal status derived from TAD and ALND will be determined based on the pathological results of the two specimens collected.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Oct 2030 (estimated)
- Study completion15 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer by AJCC V8 Anatomic StageStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janelle-Cheri Millen, MBBS, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856160
- Sponsor's protocol ID
- 750-26-FB
- Status last verified
- Aug 2026
- First submitted
- 28 Sep 2026
- Last updated
- 5 Nov 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of De-escalation of Axillary Surgery in ycN0 Breast Cancer Patients Post NAC for cN2, cN3 Disease: Evaluating the Concordance Between ypN Status From TAD and ALND
- ClinicalTrials.gov ID
- NCT07856160
- Acronym / sponsor ID
- 750-26-FB
- Keywords
- ALND, Sentinel Lymph Node Biopsy, TAD, Axillary, cN2, cN3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Oct 2030 (estimated)
- Study completion
- 15 Nov 2031 (estimated)
- First posted
- 2 Oct 2026 (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.
Recent studies have demonstrated the safety of de-escalation of nodal surgery for clinically node-positive breast cancer patients after a favorable response to neoadjuvant systemic therapy (NST). These studies excluded patients with clinically node-positive stage 2 or 3 (cN2, cN3) disease. Consequently, the current guidelines recommend axillary lymph node dissection (ALND) for patients with cN2/cN3 breast cancer, even after a favorable response to NST. Many cN2/cN3 patients achieve nodal pathologic complete response (pCR) after NST, and this has raised interest in less invasive surgical approaches for the management of the axilla in this setting. We aim to evaluate the pathologic concordance between lymph node status post neoadjuvant therapy (ypN) derived from targeted axillary dissection (TAD) and ALND performed sequentially under the same anesthesia in patients with cN2/cN3 who convert to clinically node-negative (ycN0) following completion of NST. If a high level of concordance is determined between the ypN status determined from the TAD and the ALND, our next step would be to expand the trial to include a larger number of patients, making it multi-institutional, in order to power the study for more meaningful analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: TAD, Procedure: ALNDTAD + ALND |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Females
- Aged ≥ 19 years old at time of study entry.
- Patient must be able to provide study-specific informed consent prior to study enrolment.
- Histological confirmation of breast cancer diagnosis on core needle biopsy. Pathology will be confirmed by internal UNMC review if the biopsy was completed at an outside institution.
- Clinical and/or radiographic cT1-T4 N2-3 M0 disease.
Key exclusion criteria (4 listed)
- Patients with metastatic disease at presentation.
- Patients unable to complete the recommended NST.
- Patients who are pregnant.
- Patients with a known allergic reaction to injectable blue dye.
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 |
|---|---|---|
| TADTargeted axillary dissection | Procedure or surgery | Treatment |
| ALNDAxillary lymph node dissection | Procedure or surgery | Treatment |
Primary outcome
Pathologic nodal status (ypN) derived from targeted axillary dissection (TAD) and axillary lymph node dissection (ALND.)
Time frame: 1 month
Pathologic concordance between pathologic nodal status derived from TAD and ALND will be determined based on the pathological results of the two specimens collected.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 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.
Janelle-Cheri Millen, MBBS principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A study testing TAD and ALND in people with Breast Cancer by AJCC V8 Anatomic Stage and Breast Cancer, run by University of Nebraska.
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 8 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IIT Office, MA (402-559-4596, IITOffice@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic nodal status (ypN) derived from targeted axillary dissection (TAD) and axillary lymph node dissection (ALND.) (time frame: 1 month). 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 5 Nov 2026.