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The purpose of this research is to learn if the CellSearch Circulating Tumor Cells (CTC) test can help doctors in making decisions about treatment and monitoring of breast cancer. The test consists of diagnostic CTC counts (enumeration) and expression of biomarkers Human Epidermal growth factor Receptor 2 (HER2), Estrogen Receptor (ER), and programmed death-ligand 1 (PD-L1) and cell free DNA/RNA (cfDNA/RNA) analysis.
A prospective, multicenter, observational study of CellSearch CTC enumeration, CTC HER2, ER, and PD-L1 expression, and MSearch cfDNA/RNA results in subjects with histologically proven MBC. Treatment for MBC will be chosen and performed by treating physicians/providers. Eligible subjects will be enrolled after signing the ICF. Subjects will receive CTC enumeration, CTC HER2, ER, PD-L1 expression and, and MSearch cfDNA/RNA assessments at baseline and first restaging as part of Standard of Care (SoC). Subjects will receive any additional cfDNA/RNA assessments as part of research collection. For all subjects 4 to 6 tubes will be collected at baseline and minimally before the first restaging visit. For any subsequent restaging visits a total of 3 to 4 tubes will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR+/HER2- subjects before starting 1st line therapy | Subjects will receive CTC enumeration, CTC HER2, ER, PD-L1 expression and, and MSearch cfDNA/RNA assessments at baseline and first restaging as part of standard of care. Subjects will have additional cfDNA/RNA tests at week 4, and 8. | ||
| Triple negative starting any line of therapy, HR+/HER2-, and HER2+ starting ≥2nd line therapy | Subjects will receive CTC enumeration, and CTC HER2, ER, PD-L1 expression minimally before each restaging visit, and cfDNA/RNA assessments at baseline and first restaging as part of standard of care. |
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| Measure | Description | Time Frame |
|---|---|---|
| The percentage of subjects for which the providers indicated positive impact of the cfDNA/RNA, CTC enumeration, and CTC expression results. | The percentage of subjects for which the providers indicated positive impact on treatment decisions or response assessment of the cfDNA/RNA, CTC enumeration, and CTC expression assessments.CTC enumeration, CTC biomarker expression, and cfDNA/RNA results in subjects with MBC. | 3-4 months |
| Measure | Description | Time Frame |
|---|---|---|
| The correlation of CTC expression and tissue immunohistochemistry (IHC)/In Situ Hybridization (ISH) results for HER2, ER, and PD-L1. | 1 month | |
| The correlation of CTC expression and cfDNA/RNA results for HER2, ER, and PD-L1. | 3-4 months |
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Inclusion Criteria:
OR HER2+ subjects prior to starting second line therapy or beyond in the metastatic setting.
Exclusion Criteria:
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Advanced/metastatic breast cancer of following subtypes/lines of systemic therapy in metastatic setting:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marija Balic, MD, PhD, MBA | Contact | 800-533-8762 | balicm@upmc.edu | |
| Lisette Stork-Sloots | Contact | lstork@medex15.com |
| Name | Affiliation | Role |
|---|---|---|
| Marija Balic, MD, PhD, MBA | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Magee Womens Hospital | Recruiting | Pittsburgh | Pennsylvania | 15213 | 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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| The correlation of CTC HER2, ER and PD-L1 expression with response to therapy and progression free survival (PFS). | 24 months |
| The correlation of cfDNA/RNA genomic alterations with response to therapy and PFS. | 24 months |
| The correlation of early cfDNA/RNA dynamics with response to therapy and PFS in 1st line Hormone Receptor (HR) +/HER2- MBC. | 24 months |
| The correlation of CTC enumeration results with PFS. | 24 months |
| D017437 |
| Skin and Connective Tissue Diseases |