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

Running, not enrolling

Conditions studied: Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Metastatic Breast Carcinoma, Peritoneal Effusion, Recurrent Breast Carcinoma

In brief

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.

Key facts

Study ID

NCT03737695

Run by

Mayo Clinic

People needed

300

Starts

2019-09-16

Expected to finish

2027-09-15

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• UCSF Medical Center-Mission Bay — San Francisco, California, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States
• Montefiore Medical Center-Einstein Campus — The Bronx, New York, United States
• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Pennsylvania/Abramson Cancer Center — Philadelphia, Pennsylvania, United States
• UPMC-Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
• Vanderbilt Breast Center at One Hundred Oaks — Nashville, Tennessee, United States
• FHCC South Lake Union — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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