De-Escalation of Axillary Management in Advanced Nodal Disease
ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Kansas Medical Center
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
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
Treatments tested in this trial
- Axillary Surgery
Treatment groups
120 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov