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

NCT07856160 — Not applicable, Not yet recruiting, 20 participants, University of Nebraska

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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

Registry	NCT07856160
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, supportive care
Enrollment	20 (Estimated)
Sponsor	University of Nebraska (Other)
Conditions	Breast Cancer by AJCC V8 Anatomic Stage, Breast Cancer
Interventions	TAD+ALND (Procedure)
Dates	start 2026-10-15 (estimated), primary completion 2030-10-15 (estimated), completion 2031-11-15 (estimated), first posted 2026-10-02, last updated 2026-10-02

-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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+Arms and interventions

Arm	Type	Interventions	Description
Treatment	Experimental	Procedure: TAD+ALND	TAD + ALND

TAD+ALND (Procedure): do alnd after tad

+Outcome measures

Primary outcomes

To evaluate the pathologic concordance between pathologic nodal status (ypN) derived from targeted axillary dissection (TAD) and axillary lymph node dissection (ALND.) [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.

+Eligibility

Sex: Female, ages: 19 Years to 99 Years

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:

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.

+Investigators

Janelle-Cheri Millen, MBBS, Principal investigator, University of Nebraska