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

NCT03737695 | Suspended

• 4 other identifiers: AURORA USNCI-2018-02144AURORA18-001910
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Observational (biospecimen, clinical info collection)

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.

Procedure: Biospecimen Collection; Other: Medical Chart Review

Interventions

Biospecimen Collection PROCEDURE

Undergo biospecimen collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Observational (biospecimen, clinical info collection)

Medical Chart Review OTHER

Undergo clinical information collection

Also known as: Chart Review

Observational (biospecimen, clinical info collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with recurrent and/or metastatic breast cancer of all tumor subtypes

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (14)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt Breast Center at One Hundred Oaks

Nashville, Tennessee, 37204, United States

Location

FHCC South Lake Union

Seattle, Washington, 98109, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, blood

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Karthik V. Giridhar, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 9, 2018
• Study Start: September 16, 2019
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): May 15, 2029
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (14)