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.

Study Overview

• Status: Recruiting
• Conditions: Breast Carcinoma; Recurrent Breast Carcinoma; Metastatic Breast Carcinoma
• Intervention / Treatment: Other: Non-Interventional Study

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Kathryn J. Ruddy, M.D.
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Fergus J. Couch, Ph.D.
      • Sub-Investigator: Karthik V. Giridhar, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with invasive cancer, suspected or known recurrent or metastatic lesions, as well as males with biopsy proven breast cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; Patients undergo blood sample collection, provide clinical residual tissue samples and have their medical records reviewed on study.	Other: Non-Interventional Study; Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to targeted therapies	Response to targeted therapies will be evaluated in organoid or mouse xenograft models derived from tumor biospecimens obtained from participants.	Baseline
Change in tumor cells	Changes in tumor cells will be evaluated following metastasis to other organs and after various treatments.	Baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Fergus J. Couch, Ph.D., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2014
• Primary Completion (Estimated): June 30, 2034
• Study Completion (Estimated): June 30, 2034

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 14-002919 (Other Identifier: Mayo Clinic in Rochester); NCI-2023-10076 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No