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

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.

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.

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