Axillary Ultrasound With or Without Sentinel Lymph Node Biopsy in Detecting the Spread of Breast Cancer in Patients Receiving Breast Conservation Therapy
Conditions
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Sentinel Lymph Node Biopsy
Type: Procedure
Overall Status
Recruiting
Summary
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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)

- 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
- 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 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 riks for recurrence from prior malignancies.

- Patient, or the patient's legally acceptable representative, must provide a signed and date 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.

- Patient has undergone or plans to undergo neoadjuvant chemotherapy of endocrine therapy.
Location
Washington University School of Medicine
St. Louis, Missouri, United States
Status: Recruiting
Contact: Amy Cyr, M.D. - 314-747-8708 - cyra@wudosis.wustl.edu
Start Date
April 2013
Completion Date
July 2020
Sponsors
Washington University School of Medicine
Source
Washington University School of Medicine
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page