Axillary Ultrasound With or Without Sentinel Lymph Node Biopsy in Detecting the Spread of Breast Cancer in Patients Receiving Breast Conservation Therapy
|ClinicalTrials.gov Identifier: NCT01821768|
Recruitment Status : Active, not recruiting
First Posted : April 1, 2013
Last Update Posted : March 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Procedure: Sentinel Lymph Node Biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 4, 2013|
|Estimated Primary Completion Date :||January 21, 2021|
|Estimated Study Completion Date :||January 21, 2021|
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
- Regional (axillary) recurrence [ Time Frame: 5 years from date of surgery ]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. ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821768
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Amy Cyr, M.D.||Washington University School of Medicine|