Axillary Ultrasound With or Without Sentinel Lymph Node Biopsy in Detecting the Spread of Breast Cancer in Patients Receiving Breast Conservation Therapy

In this prospective randomized non-inferiority study we aim to determine the utility of
axillary ultrasound (AUS) as a pre-operative staging modality for patients with clinically
node-negative invasive breast cancer with the hope that it will be a minimally invasive
replacement for SLNB.

Inclusion Criteria:

- Patient must be female.

- Patient must be at least 18 years of age.

- Patient's clinical stage must be documented as tumor size less than 5 cm, with no
palpable nodes and no evidence of metastatic disease (T1 or T2 N0 M0). For patients
who will receive neoadjuvant systemic therapy, pre-treatment clinical stage should be
used.

- Patient must have a negative (normal) axillary ultrasound performed at Siteman Cancer
Center. Lymph nodes will be evaluated based on morphologic features. AUS wil be
considered positive (abnormal)if lymph nodes are noted to be completely hypoechoic
(absent hilum) or have focal hypoechoic cortical thickening/lobulation greater than 4
mm.

- Patient must have a tissue diagnosis of invasive breast carcinoma

- Patient must have Eastern Cooperative Oncology Group (ECOG) status documented in patient's medical record.

- Patient must be available for follow-up.

- A patient with a history of previous malignancy is eligible for this study as long as
the patient meets the following criteria for a cancer survivor. A cancer survivor is
eligible provided that the following criteria are met (1) The patient has undergone
potentially curative therapy for all prior malignancies; (2) There has been no
evidence of any prior malignancies for at least five years with no evidence of
recurrence (except for effectively treated basal cell or squamous carcinoma of the
skin, carcinoma in-situ of the cervix that has been effectively treated by surgery
alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated
by surgery alone); and (3) The patient is deemed by their treating physician to be at
low risks for recurrence from prior malignancies.

- Patient, or the patient's legally acceptable representative, must provide a signed and
dated written informed consent prior to registration and any study-related procedures.

- Patient must provide written authorization to allow the use and disclosure of their
protected health information. NOTE: This may be obtained in either the study-specific
informed consent or in a separate authorization form and must be obtained from the
patient prior to study registration.

- Patient must be a candidate for sentinel lymph node biopsy (SLNB).

Exclusion Criteria:

- Patient in lactating (breast-feeding) or pregnant.

- Patient has concurrent invasive bilateral breast malignancies or multicentric disease.

- Patient has had previous ipsilateral axillary surgery such as excisional biopsy of
lymph nodes(s), treatment of hidradenitis.

- Patient is considered poor candidate surgical candidate due to non-malignant systemic
disease.