About this trial

This is a prospective, phase 2, single arm trial to evaluate whether Axillary Lymph Node Dissection (ALND) can be safely omitted for patients with cN2 and cN3 breast cancer who achieve a complete clinical response on exam with a complete or partial response by end-of-treatment (EOT) imaging and have either a partial or complete pathologic nodal response after neoadjuvant chemotherapy (NAC) by performing nodal assessment of sentinel lymph node surgery (with or without targeted axillary dissection (TAD) followed by Regional Nodal Irradiation (RNI).

This study aims to demonstrate that performing only a sentinel node dissection, which includes the removal of palpably gross disease followed by radiation, will not impact distant disease and thus survival.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability of participant to understand this study, and participant willingness to sign a written informed consent. NOTE Remote consenting allowed per IRB policy and approval.

Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study

Males and/or females age ≥ 18 to 80 years

Clinical stage T1-3 N2-3 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy).

Disqualifiers

Patients must have completed planned chemotherapy (neoadjuvant chemotherapy [NAC]) prior to surgery. Sandwich chemotherapy is not allowed (i.e. chemotherapy planned to be given after surgery). Adjuvant systemic therapy based on final surgical pathology is allowed and at the discretion of the treating medical oncologist. Note: Delays/dose modifications due to toxicities/adverse events are allowed per the treating medical oncologist.

Patients with HER-2 positive tumors must have received neoadjuvant trastuzumab, or trastuzumab + pertuzumab, or other approved anti-HER-2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen). Therapy must be FDA-approved targeted anti-HER2 therapy, but additional therapies are allowed as are non-trastuzumab regimens if administered in the context of an IRB-approved clinical trial.

Benign breast disease, LCIS or DCIS of contralateral breast is allowed

All patients must have a clinically negative axilla (no bulky adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy. Note: A partial or complete imaging response that includes all lymph nodes measuring ≤ 1cm clinically is required for eligibility.

Trial design

Design model

Single group

Treatments tested in this trial

Axillary Surgery
Procedure/Surgery
Patients who are clinically node negative after neoadjuvant chemotherapy by physical examination will undergo clinically indicated breast surgery (mastectomy or lumpectomy) with sentinel lymph node (SLN) surgery. Sentinel lymph node surgery must be performed within 8 weeks (56 days) after completion of the last dose of neoadjuvant chemotherapy.

Treatment groups

120 Participants

are divided into 1 treatment group

Group A: Axillary SurgeryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Disease Free Survival (DFS)

To determine if radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with regional nodal irradiation (excluding dissected axilla) for DFS after neoadjuvant chemotherapy response. DFS assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.

Time frame

5 years

Secondary outcomes

1

Invasive Breast Cancer Recurrence Free Interval (IBC - RFI)

To assess if radiation to the undissected axilla and regional nodes is not inferior to axillary dissection plus regional nodal radiation for IBC-RFI, DSS, and LRR in patients with complete or partial response to neoadjuvant chemotherapy. Determined by medical record.

Time frame

5 years

2

Disease Specific Survival (DSS)

To assess if radiation to the undissected axilla and regional nodes is not inferior to axillary dissection plus regional nodal radiation for IBC-RFI, DSS, and LRR in patients with complete or partial response to neoadjuvant chemotherapy. Determined by medical record.

Time frame

5 years

3

Locoregional Recurrence (LRR)

To assess if radiation to the undissected axilla and regional nodes is not inferior to axillary dissection plus regional nodal radiation for IBC-RFI, DSS, and LRR in patients with complete or partial response to neoadjuvant chemotherapy. Determined by medical record.

Time frame

5 years

4

Lymphedema Incidence

To estimate the incidence of arm lymphedema in participants that undergo SLN with comprehensive RNI. Determined by Bioimpedance Spectroscopy

Time frame

Measured at 9 months, annually, and PRN (as needed) per patient reported symptoms, over a duration of approximately 5 years.

Other outcomes

1

ctDNA Analysis

To evaluate ctDNA following neoadjuvant chemotherapy in participants with locally advanced breast cancer

Time frame

ctDNA will be collected prior to start of neoadjuvant chemotherapy, day of surgery, and within 30 days of completing radiation therapy

Locations

This trial has no locations.

De-Escalation of Axillary Management in Advanced Nodal Disease

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Locations

Sponsors and contacts