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

Mayo Clinic

Status: Enrolling

Conditions: Recurrent Breast Carcinoma; Metastatic Breast Carcinoma; Breast Carcinoma

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT06217874

NCI-2023-10076 (Registry Identifier)

14-002919 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

2,000 participants in 1 patient group

Observational

Description:

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

Treatment:

Other: Non-Interventional Study