Collection of Specimens and Clinical Data for Patients With Recurrent or Metastatic Breast Cancer or Male Breast Cancer
Overview
- Phase
- N/A
- Intervention
- Non-Interventional Study
- Conditions
- Breast Carcinoma
- Sponsor
- Mayo Clinic
- Enrollment
- 2000
- Locations
- 1
- Primary Endpoint
- Response to targeted therapies
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Observational
Patients undergo blood sample collection, provide clinical residual tissue samples and have their medical records reviewed on study.
Intervention: Non-Interventional Study
Outcomes
Primary Outcomes
Response to targeted therapies
Time Frame: 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
Time Frame: Baseline
Changes in tumor cells will be evaluated following metastasis to other organs and after various treatments.