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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03737695
Other study ID # AURORA US
Secondary ID NCI-2018-02144AU
Status Suspended
Phase
First received
Last updated
Start date September 16, 2019
Est. completion date November 15, 2024

Study information

Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Suspended
Enrollment 300
Est. completion date November 15, 2024
Est. primary completion date September 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically confirmed or suspected invasive breast cancer - Radiographic evidence of distant metastatic disease - Clinical or radiographic evidence of disease progression OR presenting with de novo stage IV disease - Available archived tissue from the initial breast primary (formalin fixed paraffin embedded [FFPE] tissue is acceptable; fresh frozen tissue is preferred if available) - Accessible lesion representative of recurrent or metastatic breast cancer for biopsy - Type 1 specimen collection: Patients undergoing a clinically directed tissue biopsy or tissue collection who are willing to have additional specimens taken for research during the same procedure. Sites for tissue acquisition may include the breast, skin/chest wall, lymph node/soft tissue, liver, bone, lung, brain, pleural fluid, and ascites as needed for routine clinical care - Type 2 specimen collection: Patients undergoing a tissue biopsy or tissue collection for research purposes only. Sites for tissue acquisition include the breast, skin/chest wall, lymph node/soft tissue, liver, bone, pleural fluid, and ascites. Research directed lung biopsies and brain biopsies are not permitted. Procedures for tissue acquisition are restricted to those performed under local anesthesia or intravenous (IV) conscious sedation; biopsies that require general anesthesia are not permitted in this situation - Previous cytologic confirmation of malignant pleural effusion or ascites if that is the planned source of fresh specimen collection for study participation - Age 18 years or older - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Ability to understand and the willingness to sign an informed consent document Exclusion Criteria: - Concurrent disease or condition that in the opinion of the treating oncologist or the provider performing the biopsy procedure renders the patient inappropriate for study participation - Concurrent serious medical or psychiatric disorder that may interfere with the subject's safety during the biopsy or tissue collection procedure - Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent - History of a serious or life-threatening allergic reaction to local anesthetics (e.g., lidocaine, xylocaine) used during a biopsy procedure - Pregnancy (due to the risk of conscious sedation or anesthesia to mother and fetus) - Any condition or laboratory finding that in the opinion of the treating oncologist or the provider performing the biopsy procedure would make participation in this protocol hazardous for the patient

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biospecimen Collection
Undergo biospecimen collection
Other:
Medical Chart Review
Undergo clinical information collection

Locations

Country Name City State
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States Dana-Farber Cancer Institute Boston Massachusetts
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States Duke University Medical Center Durham North Carolina
United States Vanderbilt Breast Center at One Hundred Oaks Nashville Tennessee
United States University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania
United States UPMC-Magee Womens Hospital Pittsburgh Pennsylvania
United States Mayo Clinic in Rochester Rochester Minnesota
United States UCSF Medical Center-Mission Bay San Francisco California
United States FHCC South Lake Union Seattle Washington
United States MedStar Georgetown University Hospital Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comprehensive biorepository creation Will create a comprehensive biorepository that includes blood, archival tissue, fresh tissue, and linked molecular and clinical data from patients with recurrent and/or metastatic breast cancer. Up to 2 years
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