Collection of Specimens and Clinical Data for Patients with Recurrent or Metastatic Breast Cancer or Male Breast Cancer


  • Study type

  • 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: 14-002919
    Sponsor Protocol Number: 14-002919

About this study

The purpose of this study is to collect blood samples and fresh tissue from biopsies of metastatic lesions from Mayo Clinic patients with metastatic breast cancer. The biospecimens will be used for analysis of genetic alterations in germline and tumor DNA and for tracking of response to therapy using blood-based liquid biopsy approaches. 

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:

  • Female participants must have histologically or cytologically confirmed invasive breast cancer
  • Presence or suspicion of recurrent or metastatic breast cancer is required, and only those for whom a biopsy is clinically recommended will be included (biopsy cannot be for research purposes only)
  • Male participants must have biopsy proven breast cancer
  • All participants must be able to understand and willing to sign an informed consent document.

Exclusion Criteria:

  • Dementia 
  • Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent 
  • History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine)
  • Any other condition, which in the opinion of the patient’s treating oncologist, or the physician performing the biopsy procedure, would make participation in this protocol unreasonably 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

Fergus Couch, Ph.D.

Closed-enrolling by invitation

What is this? (?)
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Jodie Cogswell



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