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The purpose of this study is to determine whether a personalized, risk-stratified surveillance strategy can safely reduce unnecessary cardiac imaging while preserving early detection of treatment-related cardiotoxicity in women with breast cancer (BC) receiving HER2-targeted therapy (HER2-TT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard-of-care Group | Active Comparator | Participants in this group will receive echocardiogram imaging before cycles 1, 5, 9, and 13 of trastuzumab (or every 3 months) and another echocardiogram after completion of trastuzumab (within 100 days after completion of HER2-TT). |
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| Judicious-imaging Group | Experimental | The Judicious Imaging Group will get split into two separate subgroups, intermediate-risk or low-risk, depending on their risk of heart failure, which will determine how many echocardiograms they will receive. The low-risk subgroup will get an echocardiogram once every 6 months (before cycles 1 and 9 and after the completion of trastuzumab). The intermediate-risk subgroup will get an echocardiogram approximately once every 4 months (before cycles 1, 6, and 12 and after completion of trastuzumab). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiogram | Procedure | 12-lead echocardiogram |
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| Measure | Description | Time Frame |
|---|---|---|
| Total Number of imaging tests | At the end of therapy, approximately 457 days | |
| Time to completion of HER 2 (human epidermal growth factor receptor 2) target therapy in days | end of therapy, approximately 457 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaily LaForce | Contact | 585-274-2808 | kaily_laforce@urmc.rochester.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmot Cancer Center | Recruiting | Rochester | New York | 14642 | United States |
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