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

NCT04906369 | Suspended

• 2 other identifiers: 20-001670NCI-2021-04104
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Prognostic Stage IV Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (2)

• 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

• Detection of treatment failure

  Defined as progression of disease on imaging studies.

  Up to 1 year

Secondary Outcomes (1)

• 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

Other Outcomes (1)

• Evaluation of immunity to target antigens and neoantitopes in metastatic breast cancer

  Up to 1 year

Study Arms (1)

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.

Procedure: Biospecimen Collection

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Ancillary-Correlative (biospecimen collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at Mayo Clinic Cancer Center that are undergoing treatment for stage IV breast cancer.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Brenda J. Ernst, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 28, 2021
• Study Start: November 16, 2020
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)