HER2/Neu Negative Clinical Trial
Official title:
Intensive Trial of OMics in Cancer (ITOMIC) - Intensive Longitudinal Monitoring in Subjects With Triple-Negative Breast Cancer
This pilot research trial studies collecting, analyzing, and storing samples from patients with triple negative breast cancer (breast cancer cells that do not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 protein) that has spread to other places in the body receiving anti-cancer therapy. Studying samples of tissue, blood, buccal swab, saliva, and urine in the laboratory from patients receiving anti-cancer therapy may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.
PRIMARY OBJECTIVES: I. To establish the safety and feasibility of collecting, analyzing and storing clinically annotated panomic and other data from serially monitored subjects with metastatic triple negative breast cancer (TNBC) who receive care from up to ten oncology practices across the United States. SECONDARY OBJECTIVES: I. To determine whether molecular changes associated with resistance to treatment can be identified. II. To understand subject perceptions regarding panomic data and its application to cancer treatment. III. To apply other technologies to the characterization of subject tumors as they become available. OUTLINE: Patients undergo collection of tissue biopsy, blood, buccal mucosa, saliva, and urine at baseline. Additional biopsies may be performed prior to treatment change. After completion of biopsy, patients are followed up at 1 day and 7 days. Patients will be followed indefinitely or for as long as they agree to be in the study, depending on the availability of resources. ;
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