Optimizing Treatment of Stage IV Breast Cancer Through Real-Time Disease Monitoring
June 5, 2026 updated by: Mayo Clinic
Optimizing Treatment of Metastatic Breast Cancer Through Real-Time Disease Monitoring
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.
Study Overview
Status
Suspended
Conditions
Intervention / 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 Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arizona
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Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients at Mayo Clinic Cancer Center that are undergoing treatment for stage IV breast cancer.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Undergo collection of blood samples
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Up to 1 year
|
|
Detection of treatment failure
Time Frame: Up to 1 year
|
Defined as progression of disease on imaging studies.
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
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
Time Frame: Up to 1 year
|
shallow whole genome sequencing circulating tumor-derived DNA analysis results with available serologic tumor biomarkers
|
Up to 1 year
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluation of immunity to target antigens and neoantitopes in metastatic breast cancer
Time Frame: Up to 1 year
|
Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Brenda J. Ernst, M.D., Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 16, 2020
Primary Completion (Estimated)
December 30, 2027
Study Completion (Estimated)
December 30, 2027
Study Registration Dates
First Submitted
May 21, 2021
First Submitted That Met QC Criteria
May 25, 2021
First Posted (Actual)
May 28, 2021
Study Record Updates
Last Update Posted (Actual)
June 9, 2026
Last Update Submitted That Met QC Criteria
June 5, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-001670 (Mayo Clinic in Arizona)
- NCI-2021-04104 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.