Optimizing Treatment of Stage IV Breast Cancer Through Real-Time Disease Monitoring
NCT ID: NCT04906369
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
150 participants
OBSERVATIONAL
2020-11-16
2027-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Biospecimen Collection
Undergo collection of blood samples
Interventions
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Biospecimen Collection
Undergo collection of blood samples
Eligibility Criteria
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Inclusion Criteria
* Stage IV breast cancer undergoing cancer treatment
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Brenda J. Ernst, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Countries
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Other Identifiers
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NCI-2021-04104
Identifier Type: REGISTRY
Identifier Source: secondary_id
20-001670
Identifier Type: -
Identifier Source: org_study_id
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