Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer Who Have Residual Disease After Neoadjuvant Systemic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 999
- 试验地点
- 1
- 主要终点
- Generate patient derived xenografts (PDX) and organoids from breast cancer patients with residual disease after neoadjuvant therapy
研究概览
简要总结
Breast cancer patients who undergo neoadjuvant systemic therapy and have residual breast cancer identified at the time of surgery exhibit a high (>50%) risk of future life-threatening recurrences and death.
详细描述
This study is being done to collect blood and leftover surgical tissue from patients with breast cancer remaining after chemotherapy or endocrine therapy is completed. We will use the blood and tissue for future studies. These studies will try to find ways to treat future breast cancer patients.
Because there is cancer left in your body after breast cancer treatment is finished, we think the cancer may be different than other cancers. Tissue from surgery will be used to try to grow that kind of cancer in the lab so we can find out more about it and how to treat it.
Blood samples will be used to look at measurements of biomarkers to see how this cancer is different and seek new ways to identify and treat it.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age ≥18 years.
- •Diagnosis of invasive breast cancer treated with neoadjuvant systemic therapy.
- •Surgically resectable disease following neoadjuvant systemic treatment.
- •At least one of the following must be true:
- •Received at least 2 weeks of neoadjuvant endocrine therapy
- •Received at least 2 months of neoadjuvant chemotherapy with suggestion of residual disease on imaging
- •Began neoadjuvant chemotherapy or endocrine therapy but discontinued due to evidence of progressive disease by MRI, ultrasound, or physical examination
- •Provide written informed consent.
- •Willing to return to enrolling institution for breast cancer surgery.
- •Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic.
- •Willingness to provide mandatory tissue specimens for future research on breast cancer at Mayo Clinic.
- •Willingness to provide mandatory tissue specimens for the generation of PDX and organoids to be used future research on breast cancer at Mayo Clinic.
排除标准
- •Ineligible for surgery.
- •History of prior malignancy <3 years prior to registration. Exceptions for non-melanoma skin cancer, papillary thyroid cancer, non-invasive cancer (e.g., carcinoma in situ of the cervix).
结局指标
主要结局
Generate patient derived xenografts (PDX) and organoids from breast cancer patients with residual disease after neoadjuvant therapy
时间窗: Up to 12 months until death or a maximum of 20 years post registration
次要结局
- Utilize patient derived xenografts (PDX) models to identify mechanisms of treatment resistance(Up to 12 months until death or a maximum of 20 years post registration)
- Correlate the association between Circulating Tumor Cells (CTCs) with residual cancer burden(Up to 12 months until death or a maximum of 20 years post registration)
- Generate autologous co-culture systems of peripheral blood immune cells and breast cancer tumor cells to study the endogenous antitumor immune response(Up to 12 months until death or a maximum of 20 years post registration)
- Utilize patient derived xenografts (PDX) models to study new drugs/drug combinations(Up to 12 months until death or a maximum of 20 years post registration)
- Correlate the association between Cell Free DNA (cfDNA), Circulating Tumor Cells (CTCs) and circulating immune cell subpopulations (as measured by CyTOF) with residual cancer burden(Up to 12 months until death or a maximum of 20 years post registration)
- Correlate the association between Cell Free DNA (cfDNA) with residual cancer burden(Up to 12 months until death or a maximum of 20 years post registration)
- Correlate the association between circulating immune cell subpopulations (as measured by Cytometry by time-of-flight (CyTOF) with residual cancer burden(Up to 12 months until death or a maximum of 20 years post registration)