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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: No sentinal lymph node biopsy | No Intervention | Patients will receive no additional axillary surgery which is experimental. | |
| Arm 2: Sentinel lymph node biopsy | Active Comparator | Patients will receive standard of care sentinel lymph node biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentinel Lymph Node Biopsy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years from date of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At least 5 years form date of surgery to date of any disease recurrence. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Cyr, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| 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. | 5 years from date of surgery |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D021701 | Sentinel Lymph Node Biopsy |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008197 | Lymph Node Excision |
| D008919 | Investigative Techniques |
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