Collection of Specimens and Clinical Data for Patients With Recurrent or Metastatic Breast Cancer or Male Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional Study.
- Who it may be relevant to
- Registry conditions: Breast Carcinoma, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Non-Interventional Study
Non-interventional study
Primary outcome measures
- Response to targeted therapies [Time frame: Baseline]
- Change in tumor cells [Time frame: Baseline]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT06217874 · 14-002919 · NCI-2023-10076 · 14-002919