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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19-99
SponsorUniversity of Nebraska

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • TAD+ALND

    Procedure/Surgery

    do alnd after tad

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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