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


About this study

The purposes of this study are (i) to obtain and study biospecimens from patients with breast cancer that has either spread out of the breast or recurred after initial treatment(s), such as surgery, chemotherapy, and/or radiation, and (ii) to collect information about patients, treatments, and the behavior of the underlying cancer. Research involving biospecimens that are linked to related medical information is one way to learn more about diseases. In this case, we seek to understand the mechanism of tumor spread and determine why people respond differently to specific cancer treatments. In general terms, scientists will study the cells, DNA, RNA, and proteins found in the tumor tissue and/or the blood to understand more about cancer and the body’s response to cancer and related treatments.

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Open for enrollment

Contact information:

Minetta Liu M.D.



More information


Publications are currently not available

Study Results Summary

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Supplemental Study Information

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