Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06217874

Conditions

Breast Carcinoma

Metastatic Breast Carcinoma

Recurrent Breast Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

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.

Conditions

Breast Carcinoma

Metastatic Breast Carcinoma

Recurrent Breast Carcinoma

Study ID

NCT06217874

Start date

Jun 5, 2014

Status verified date

Feb, 2026

Completion date

Jun 30, 2034

Anticipated

Primary completion date

Jun 30, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

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

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Response to targeted therapies [ Time Frame: Baseline ]
  • Change in tumor cells [ Time Frame: Baseline ]

Central Contacts and Locations

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Fergus J. Couch, Ph.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-25.