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
• 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
• 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

Related Conditions & MeSH terms

• Anatomic Stage IV Breast Cancer AJCC v8
• Breast Neoplasms
• Metastatic Breast Carcinoma
• Prognostic Stage IV Breast Cancer AJCC v8

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

External Links

•   Mayo Clinic Clinical Trials