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Observational Study for Recurrent or Metastatic Breast Cancer

This study is collecting samples and health information from people with recurrent (cancer that has come back) or metastatic (cancer that has spread) breast cancer, or male breast cancer. The goal is to create a resource that helps researchers better understand how these cancers develop, progress, and respond to treatments. You can join if you are 18 years or older and have been diagnosed with invasive breast cancer (for women) or biopsy-proven breast cancer (for men). This is an observational study, meaning no new treatments are being tested. Researchers will look at how your tumor cells change and your response to targeted therapies at the beginning of the study. The current recruitment status is unclear.

Study design
This is an observational study planning to include 2000 participants. It is not testing a specific drug or intervention.
What's involved
You would provide blood samples, residual tissue samples from biopsies, and allow researchers to review your medical records.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT06217874

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

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~2,000 participants
Updated 2026-02-25 on ClinicalTrials.gov
What's tested:Non-Interventional Study

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response to targeted therapies
Measured over Baseline
+1 more outcome measured

Conditions

Breast Carcinoma
Metastatic Breast Carcinoma
Recurrent Breast Carcinoma

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Breast Carcinoma

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Fergus J. Couch, Ph.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Female participants must have histologically or cytologically confirmed invasive breast cancer.
Male participants must have biopsy proven breast cancer.
Age must be \>= 18 years, and all must be able to understand and willing to sign an informed consent document.

Exclusion

Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent; a 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.

What this trial measures

  • Response to targeted therapiesBaseline

    Response to targeted therapies will be evaluated in organoid or mouse xenograft models derived from tumor biospecimens obtained from participants.

  • Change in tumor cellsBaseline

    Changes in tumor cells will be evaluated following metastasis to other organs and after various treatments.