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

Suspended

• Conditions: Metastatic Breast Carcinoma; Prognostic Stage IV Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8
• Interventions: Procedure: Biospecimen Collection

• Registration Number: NCT04906369
• Lead Sponsor: Mayo Clinic

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 Timeline

• Study Start: 2020-11-16
• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-28
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-26
• Primary Completion: 2024-11-15
• Study Completion: 2024-11-15

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Adults > 18 years of age
• Stage IV breast cancer undergoing cancer treatment

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (biospecimen collection)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States