NCT01957514

Collecting, Analyzing, and Storing Samples From Patients With Metastatic, Triple Negative Breast Cancer Receiving Anti-cancer Therapy

Intensive Trial of OMics in Cancer (ITOMIC) - Intensive Longitudinal Monitoring in Subjects With Triple-Negative Breast Cancer

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Estrogen Receptor Negative
• HER2/Neu Negative
• Progesterone Receptor Negative
• Stage IV Breast Cancer AJCC v6 and v7
• Triple-Negative Breast Carcinoma

Interventions

Type	Name	Description
OTHER	Cytology Specimen Collection Procedure	Undergo tissue biopsy, blood, buccal mucosa, saliva, and urine collection
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2013-10-28
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2013-10-08
• Last updated: 2021-09-30

Locations

2 sites across 1 country: United States