Optimizing Treatment of Metastatic Breast Cancer Through Real-Time Disease Monitoring
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Mayo Clinic
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Detection of treatment failure
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Biospecimen Collection (Procedure)
Outcomes
Primary Outcomes
Detection of treatment failure
Time Frame: Up to 1 year
Defined as progression of disease on imaging studies.
Identification of patients with high circulating tumor-derived deoxyribonucleic acid (ctDNA) fractions (> 50%)
Time Frame: 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).
Secondary Outcomes
- 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)