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

NCT07856160 | Not Yet Recruiting DMC

• 1 other identifier: 750-26-FB
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer by AJCC V8 Anatomic Stage; Breast Cancer

Keywords

ALND; Sentinel Lymph Node Biopsy; TAD; Axillary; cN2; cN3

Outcome Measures

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.

  1 month

Study Arms (1)

Treatment

EXPERIMENTAL

TAD + ALND

Procedure: TAD+ALND

Interventions

TAD+ALND PROCEDURE

do alnd after tad

Treatment

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Janelle-Cheri Millen, MBBS

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IIT Office, MA

CONTACT

402-559-4596; IITOffice@unmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): October 15, 2030
• Study Completion (Estimated): November 15, 2031
• Last Updated: October 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share