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NCT06217874 Clinical Trial

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

Breast Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06217874
Other study ID # 14-002919
Secondary ID NCI-2023-1007614
Status Recruiting
Phase
First received
Last updated
Start date June 5, 2014
Est. completion date June 30, 2034

Study information
Verified date January 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date June 30, 2034
Est. primary completion date June 30, 2034
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Non-Interventional Study
Non-interventional study

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Change in tumor cells Changes in tumor cells will be evaluated following metastasis to other organs and after various treatments. Baseline
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