This trial collects clinical information and tissue and blood samples from patients with breast cancer that has come back or is stage IV. Collecting clinical information and biospecimen samples to create a registry may help doctors better understand the mechanism of tumor spread and determine why people respond differently to specific cancer treatments.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03737695.
PRIMARY OBJECTIVES:
I. To create a comprehensive registry that includes patient demographics, clinical and histopathological data, blood samples, and tissue specimens from the primary tumor and metastatic sites of patients with metastatic breast cancer to improve our understanding of the mechanisms of tumor metastasis and therapeutic resistance.
II. To conduct genomic studies of paired primary tumors and distant metastatic sites.
III. To conduct genomic studies of paired distant metastatic sites obtained during the course of an individual’s disease.
IV. To conduct genomic studies of cell free deoxyribonucleic acid (DNA), circulating tumor cell (CTC) derived DNA, germline DNA, and immune based markers in the peripheral circulation.
SECONDARY OBJECTIVE:
I. To evaluate the concordance between DNA sequencing results obtained from a clinically available assay and those obtained specifically for research purposes.
OUTLINE:
Patients' archival and newly collected tissue and blood samples are collected periodically for genetic testing. Patients also undergo collection of clinical information within 30 days of biopsy procedure and every 4 months.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorKarthik Vikram Giridhar
