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Brief Title: Clinical Information and Biospecimen Collection From Patients With Recurrent or Stage IV Breast Cancer
Official Title: AURORA US: Prospective Biospecimen Repository in Metastatic Breast Cancer
Study ID: NCT03737695
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UCSF Medical Center-Mission Bay, San Francisco, California, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
UPMC-Magee Womens Hospital, Pittsburgh, Pennsylvania, United States
Vanderbilt Breast Center at One Hundred Oaks, Nashville, Tennessee, United States
FHCC South Lake Union, Seattle, Washington, United States
Name: Karthik V. Giridhar, M.D.
Affiliation: Mayo Clinic
Role: PRINCIPAL_INVESTIGATOR