Axillary Ultrasound With or Without Sentinel Lymph Node Biopsy in Detecting the Spread of Breast Cancer in Patients Receiving Breast Conservation Therapy
Axillary Ultrasound With or Without Sentinel Lymph Node Biopsy in Detecting the Spread of Breast Cancer in Patients Receiving Breast Conservation Therapy
This randomized clinical trial studies two different tests that are currently being used to
 detect the spread of breast cancer to the lymph nodes under the arm in candidates for breast
 conservation therapy. The two tests are sentinel lymph node biopsy (SLNB) and axillary
 ultrasound. The current standard of care is sentinel lymph node biopsy, which is a surgical
 procedure. Axillary ultrasound (AUS) may be just as good as SLNB for detecting the spread of
 cancer but without the surgical risks.
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 </= 2, as
 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.