NCT03737695

Clinical Information and Biospecimen Collection From Patients With Recurrent or Stage IV Breast Cancer

AURORA US: Prospective Biospecimen Repository in Metastatic Breast Cancer

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Invasive Breast Carcinoma
• Metastatic Breast Carcinoma
• Peritoneal Effusion
• Recurrent Breast Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo biospecimen collection
OTHER	Medical Chart Review	Undergo clinical information collection

Timeline

• Start date: 2019-09-16
• Primary completion: 2026-09-15
• Completion: 2029-05-15
• First posted: 2018-11-09
• Last updated: 2026-03-18

Locations

14 sites across 1 country: United States