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| Name | Class |
|---|---|
| Medex15 | INDUSTRY |
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ACT-MBC prospectively assesses the impact of CTCs on treatment decisions, response assessment and prognosis in MBC patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CellSearch Circulating Tumor Cells | Diagnostic Test | Serial CTC enumeration |
| Measure | Description | Time Frame |
|---|---|---|
| To prospectively evaluate the impact of CellSearch CTCs on treatment decisions and response assessment in MBC patients | Assessing proportion of providers that find CellSearch CTCs helpful in determining response to therapy in each unique patient (Questionnaire #2). | 3 to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess barriers and receptiveness of providers in using CTCs in clinical practice | Assessing provider perception of the general usefulness of CTC in pre and post-intervention surveys (Questionnaire #1 and #3) | 18 months |
| Evaluate if CTC results correlate with response assessment and disease progression defined by standard of care imaging |
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Inclusion Criteria:
Exclusion Criteria:
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Advanced/metastatic breast cancer of following subtypes/lines of systemic therapy in metastatic setting:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Health System Albert Lea | Albert Lea | Minnesota | 56007 | United States | ||
| Mayo Clinic Health System Mankato |
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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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Cell-Free DNA (cfDNA)
Compare baseline and on treatment serial CTCs assessment to identify correlations with first restaging studies and with progression free survival |
| 18 months |
| Mankato |
| Minnesota |
| 56001 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| MCHS Eau Claire | Eau Claire | Wisconsin | 54703 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |