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

Recruiting

• Conditions: Metastatic Breast Carcinoma; Recurrent Breast Carcinoma; Breast Carcinoma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06217874
• Lead Sponsor: Mayo Clinic

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.

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, tumor biopsy and have their medical records reviewed on study.

Study Timeline

• Study Start: 2014-06-05
• Study First Submitted: 2024-01-03
• Study First Submitted QC: 2024-01-11
• Study First Posted: 2024-01-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06
• Primary Completion: 2034-06-30
• Study Completion: 2034-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients undergo blood sample collection, tumor biopsy (during clinically scheduled biopsy), and have their medical records reviewed on study.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States