Collection of Specimens and Clinical Data for Patients With Recurrent or Metastatic Breast Cancer or Male Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Response to targeted therapies
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Observational
Patients undergo blood sample collection, provide clinical residual tissue samples and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Response to targeted therapies
时间窗: 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
时间窗: Baseline
Changes in tumor cells will be evaluated following metastasis to other organs and after various treatments.
次要结局
未报告次要终点