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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
69
Washington University School of Medicine
St Louis, Missouri, United States
Regional (axillary) recurrence
The distributions of the primary endpoints and complications across two arms will be summarized using contingency tables and compared by 2-sample Chi-square test or Fisher's exact test.
Time frame: 5 years from date of surgery
Disease free survival Arm 1 versus Arm 2.
Defined as the interval between the date of registration to the date of first disease event. Kaplan-Meier product limit estimator will be used. The differences in OS and DFS between treatment arms will be compared using log-rank test.
Time frame: At least 5 years form date of surgery to date of any disease recurrence.
Overall survival Arm 1 versus Arm 2
Defined as the interval between the date of initial diagnosis until the date of death. Kaplan-Meier product limit estimator will be used. The differences in OS and DFS between treatment arms will be compared using log-rank test.
Time frame: 5 years from date of surgery
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