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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06217874

Enrollment

2000

Registered

2024-01-23

Start date

2014-06-05

Completion date

2034-06-30

Last updated

2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Carcinoma, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma

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, provide clinical residual tissue samples and have their medical records reviewed on study.

Interventions

OTHERNon-Interventional Study

Non-interventional study

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORFergus J. Couch, Ph.D.

Mayo Clinic in Rochester

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026