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

Anatomic Stage IV Breast Cancer AJCC v8 Clinical Trial

Official title:

AURORA US: Prospective Biospecimen Repository in Metastatic Breast Cancer

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03737695
• Other study ID #: AURORA US
• Secondary ID: NCI-2018-02144AU
• Status: Suspended
• 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
• 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

Related Conditions & MeSH terms

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

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