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Not yet recruitingNCT07856160Updated Oct 2, 2026

De-escalation of Axillary Dissection for Node-positive Breast Cancer

An interventional study of TAD+ALND in Breast Cancer by AJCC V8 Anatomic Stage and Breast Cancer, sponsored by University of Nebraska. Not yet recruiting. Open to female participants aged 19 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by University of Nebraska · Not applicable, Interventional, and Supportive care

Updated Oct 2, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
19 Years to 99 Years
Sex
Female
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Study 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. 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.

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Conditions studied

  • Breast Cancer by AJCC V8 Anatomic Stage
  • Breast Cancer

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Keywords

  • ALND
  • Sentinel Lymph Node Biopsy
  • TAD
  • Axillary
  • cN2
  • cN3
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 20 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Nebraska is the lead sponsor of 473 studies on the registry; 66 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 99 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Females
  2. Aged ≥ 19 years old at time of study entry.
  3. Patient must be able to provide study-specific informed consent prior to study enrolment.
  4. 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.
  5. Clinical and/or radiographic cT1-T4 N2-3 M0 disease.
  6. Patients must complete NST. Patients who complete all recommended cycles of NST, regardless of dose reductions, are eligible.
  7. Clinical and radiographic (breast MRI with and without contrast) re-evaluation following completion of NST.
  8. Achievement of a complete clinical and radiographic nodal response (ycN0).

Exclusion criteria

Exclusion Criteria:

  1. Patients with metastatic disease at presentation.
  2. Patients unable to complete the recommended NST.
  3. Patients who are pregnant.
  4. Patients with a known allergic reaction to injectable blue dye.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Treatment

    TAD + ALND

    Procedure: TAD+ALND

Interventions

  • ProcedureTAD+ALND

    do alnd after tad

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What researchers measure

Primary outcomes

  1. To evaluate the pathologic concordance between 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.

    Time frame: 1 month

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07856160
Lead sponsor
University of Nebraska
Responsible party
Sponsor
First posted
Oct 2, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Oct 15, 2030 (estimated)
Completion
Nov 15, 2031 (estimated)
Last update
Oct 2, 2026

Study contacts

IIT Office, MA
Contact
IITOffice@unmc.edu
402-559-4596
Janelle-Cheri Millen, MBBS
principal investigator · University of Nebraska

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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