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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Prospective Randomized Trial of Sentinel Lymph Node Biopsy Versus no Additional Staging in Patients With Clinical T1-T2 N0 M0 Invasive Breast Cancer and Negative Axillary Ultrasound|
- Regional (axillary) recurrence [ Time Frame: 5 years from date of surgery ] [ Designated as safety issue: No ]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.
- Disease free survival Arm 1 versus Arm 2. [ Time Frame: At least 5 years form date of surgery to date of any disease recurrence. ] [ Designated as safety issue: No ]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.
- Overall survival Arm 1 versus Arm 2 [ Time Frame: 5 years from date of surgery ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||July 2020|
|Estimated Primary Completion Date:||July 2020 (Final data collection date for primary outcome measure)|
No Intervention: Arm 1: No sentinal lymph node biopsy
Patients will receive no additional axillary surgery which is experimental.
Active Comparator: Arm 2: Sentinel lymph node biopsy
Patients will receive standard of care sentinel lymph node biopsy
|Procedure: Sentinel Lymph Node Biopsy|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01821768
|Contact: Amy Cyr, M.D.||firstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|St. Louis, Missouri, United States, 63110|
|Contact: Amy Cyr, M.D. 314-747-8708 email@example.com|
|Sub-Investigator: William Gillanders, M.D.|
|Sub-Investigator: Natalia Tucker, M.D.|
|Sub-Investigator: Timothy Eberlein, M.D.|
|Sub-Investigator: Julie Margenthaler, M.D.|
|Sub-Investigator: Rebecca Aft, M.D., Ph.D.|
|Sub-Investigator: Catherine Appleton, M.D.|
|Sub-Investigator: Valerie Reichert, M.D.|
|Sub-Investigator: Imran Zoberi, M.D.|
|Sub-Investigator: Timothy Pluard, M.D.|
|Sub-Investigator: Foluso Ademuyiwa, M.D.|
|Principal Investigator:||Amy Cyr, M.D.||Washington University School of Medicine|