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NCT04906369 Clinical Trial

Optimizing Treatment of Stage IV Breast Cancer Through Real-Time Disease Monitoring

Anatomic Stage IV Breast Cancer AJCC v8 Clinical Trial

Official title:
Optimizing Treatment of Metastatic Breast Cancer Through Real-Time Disease Monitoring

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT04906369
Other study ID # 20-001670
Secondary ID NCI-2021-04104
Status Suspended
Phase
First received
Last updated
Start date November 16, 2020
Est. completion date November 15, 2024

Study information
Verified date December 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Suspended
Enrollment 150
Est. completion date November 15, 2024
Est. primary completion date November 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood samples

Locations
Country Name City State
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Evaluation of immunity to target antigens and neoantitopes in metastatic breast cancer Up to 1 year
Primary 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
Primary Detection of treatment failure Defined as progression of disease on imaging studies. Up to 1 year
Secondary 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
See also
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