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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03737695
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : March 15, 2021
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

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.

Condition or disease Intervention/treatment
Anatomic Stage IV Breast Cancer AJCC v8 Ascites Invasive Breast Carcinoma Malignant Pleural Effusion Metastatic Breast Carcinoma Prognostic Stage IV Breast Cancer AJCC v8 Recurrent Breast Carcinoma Procedure: Biospecimen Collection Other: Medical Chart Review

Detailed Description:


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.


I. To evaluate the concordance between DNA sequencing results obtained from a clinically available assay and those obtained specifically for research purposes.


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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Biospecimen Repository in Metastatic Breast Cancer
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : November 5, 2021
Estimated Study Completion Date : November 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Ancillary-Correlative (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
Undergo biospecimen collection

Other: Medical Chart Review
Undergo clinical information collection
Other Name: Chart Review

Primary Outcome Measures :
  1. Comprehensive biorepository creation [ Time Frame: Up to 2 years ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Both men and women with breast cancer

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03737695

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United States, California
UCSF Recruiting
San Francisco, California, United States, 94158
Contact: Amy DeLuca    415-353-7288   
Principal Investigator: Hope Rugo, M.D.         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Kaylee Saavedra    773-702-5952   
Principal Investigator: Rita Nanda, M.D.         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Nancy McCullough    734-936-8538   
Principal Investigator: Catherine Van Poznak, M.D.         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015   
Principal Investigator: Minetta C. Liu, M.D.         
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Kendalyn Stephens, MPH    919-962-5052   
Principal Investigator: Lisa Carey, MD         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710-1000
Contact: Keiana Watkins, MSPH    919-660-1278   
Principal Investigator: Carey Anders, M.D.         
United States, Pennsylvania
Magee-Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Trisha Schneider    412-641-4706   
Principal Investigator: Adam Brufsky, MD         
United States, Tennessee
Vanderbilt Breast Center at One Hundred Oaks Recruiting
Nashville, Tennessee, United States, 37204
Contact: Vanderbilt-Ingram Cancer Center Clinical Trials Office    800-811-8480   
Principal Investigator: Ben Park, MD, PhD         
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Shaveta Vinayak, MD    206-606-6329   
Principal Investigator: Shaveta Vinayak, MD         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
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Principal Investigator: Minetta Liu Mayo Clinic
Additional Information:
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Responsible Party: Mayo Clinic Identifier: NCT03737695    
Other Study ID Numbers: AURORA US
NCI-2018-02144 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AURORA US ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Pleural Effusion, Malignant
Pleural Effusion
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Pleural Diseases
Respiratory Tract Diseases
Pathologic Processes
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms