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OpenTrials
Recruiting

NCT Number: NCT06217874

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

This study is being done to create a resource of samples and information that can be used to improve our understanding of the development, progression and treatment of recurrent or metastatic breast cancer or male breast cancer.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Fergus J. Couch, Ph.D.

PRINCIPAL_INVESTIGATOR

Karthik V. Giridhar, M.D.

SUB_INVESTIGATOR

Kathryn J. Ruddy, M.D.

PRINCIPAL_INVESTIGATOR

About this study

PRIMARY OBJECTIVE:

I. To collect blood samples and fresh tissue from biopsies of metastatic lesions from Mayo Clinic patients with metastatic breast cancer.

OUTLINE: This is an observational study.

Patients undergo blood sample collection, provide clinical residual tissue samples and have their medical records reviewed on study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. Response to targeted therapies

    Time frame: Baseline

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

  2. Change in tumor cells

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2014
Primary completion
2034
Study completion
2034
First posted
Jan 23, 2024
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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