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| ID | Type | Description | Link |
|---|---|---|---|
| 16-1583 | Other Identifier | UNC Chapel Hill IRB |
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The purpose of this research study is to determine how feasible and accurate identifying and removing specific lymph nodes in the axilla (armpit) after neoadjuvant systemic therapy is when patients present with breast cancer that has spread to lymph nodes in the axilla. The specific lymph nodes removed would be determined at the time of diagnosis. If a biopsy proves that cancer has spread to a lymph node, a titanium clip will placed in it to mark it for future removal. That lymph node will be removed after systemic therapy and compared with the rest of the lymph nodes removed from that region.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted Axillary Dissection | Experimental | After patients have completed their neoadjuvant systemic therapy, they will have a Savi Scout® electromagnetic reflector placed into the clipped axillary lymph nodes. The surgeon will then use the Savi Scout detector intraoperatively to identify and remove your clipped lymph nodes prior to removing the remainder of the axillary lymph nodes in a surgery called an "axillary dissection". |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAD | Procedure | the same intervention as listed in the arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| The false negative rate of TAD | will be defined as the percentage of patients in whom the lymph nodes identified with TAD were free of residual metastatic disease while remaining metastatic disease was demonstrated in the completion axillary lymph node dissection | two years |
| Measure | Description | Time Frame |
|---|---|---|
| Nodal pathologic complete response | will be defined as no residual carcinoma in any lymph node sampled during TAD and/or ALND. | two years |
| The percentage of lymph nodes removed with ALND not identified by TAD that harbor residual metastasis |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC- Chapel Hill Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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will be calculated by the formula: (# pos LN/# LN sampled by ALND) x 100
| two years |
| The success rate of preoperative localization with the Savi Scout® | will be determined by the number of reflectors placed versus the number of reflectors detected at the time of surgery. | two years |
| D017437 |
| Skin and Connective Tissue Diseases |