A Study to Collect Clinical Data, Blood Samples, and Tissue Specimens from Patients with Metastatic Breast Cancer

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 18-001910
    NCT ID: NCT03737695
    Sponsor Protocol Number: 18-001910

About this study

The primary objective of this study is 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 underging 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 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
  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Contact us for the latest status

Contact information:

Minetta Liu M.D.

(507)293-0526

Liu.Minetta@mayo.edu

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions