Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of blood samples
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults \> 18 years of age * Stage IV breast cancer undergoing cancer treatment
Exclusion criteria
* Stage I-III breast cancer * Unwilling or unable to give consent * Patients with a prior or concurrent malignancy, excluding non-melanoma skin cancers and non-invasive cancers whose natural history or treatment does not have the potential to interfere with the assessment of the investigational marker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of patients with high circulating tumor-derived deoxyribonucleic acid (ctDNA) fractions (> 50%) | Up to 1 year | 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). |
| Detection of treatment failure | Up to 1 year | Defined as progression of disease on imaging studies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of shallow whole genome sequencing circulating tumor-derived DNA analysis results with available serologic tumor biomarkers used as a standard in clinical practice | Up to 1 year | shallow whole genome sequencing circulating tumor-derived DNA analysis results with available serologic tumor biomarkers |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrenda J. Ernst, M.D.
Mayo Clinic
Outcome results
None listed