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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-04104 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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lack of funding
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This study evaluates if blood tests can detect changes in disease status during treatment for stage IV breast cancer. Information from this study may help researchers learn more about metastatic breast cancer and how to optimize treatment.
PRIMARY OBJECTIVES:
I. To identify subtype-specific signatures for breast cancer using genomic positioning of plasma deoxyribonucleic acid (DNA) fragments.
II. To validate changes in circulating tumor-derived DNA (ctDNA) levels as a biomarker for treatment monitoring in patients with metastatic breast cancer.
OUTLINE:
Patients undergo collection of blood samples at baseline, 2 weeks after the start of treatment, and at the beginning of each new treatment cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ancillary-Correlative (biospecimen collection) | Patients undergo collection of blood samples at baseline, 2 weeks after the start of treatment, and at the beginning of each new treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification of patients with high circulating tumor-derived deoxyribonucleic acid (ctDNA) fractions (> 50%) | Will analyze across all three subtypes: Estrogen receptor positive (ER+), human epidermal growth factor receptor 2 positive (HER2+), and triple-negative breast cancer (TNBC). Will perform 30x whole genome sequencing (WGS) and generate subtype-specific pooled nucleosome occupancy maps. By comparing these maps with healthy volunteers, we will identify a set of loci across the genome most informative of cancer contribution in cell-free DNA (cfDNA). | Up to 1 year |
| Detection of treatment failure | Defined as progression of disease on imaging studies. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of shallow whole genome sequencing circulating tumor-derived DNA analysis results with available serologic tumor biomarkers used as a standard in clinical practice | shallow whole genome sequencing circulating tumor-derived DNA analysis results with available serologic tumor biomarkers | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of immunity to target antigens and neoantitopes in metastatic breast cancer | Up to 1 year |
Inclusion Criteria:
Exclusion Criteria:
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Patients at Mayo Clinic Cancer Center that are undergoing treatment for stage IV breast cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Brenda J. Ernst, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | 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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Plasma
| D017437 |
| Skin and Connective Tissue Diseases |