Predicting Response of Metastatic Triple Negative Breast Cancer to Immunotherapy Based on Patients Cytokine Profile
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
Recent progress in immunotherapy (IT) has shifted treatment paradigms for multiple malignancies including breast cancer. It has been shown that levels of certain cytokines were correlated with increased response to immunotherapy in patients with metastatic breast cancer. In this study investigators will perform cytokine profiling among patients diagnosed with metastatic triple-negative breast cancer at different time points during the treatment.
详细描述
This is a prospective study that has two groups of patients as determined by their prescribed treatment plan. Group A (control group) are patients with metastatic triple-negative breast cancer (TNBC) who receive chemotherapy only (current standard of care). Group B (experimental group) are patients with mTNBC who receive a combination of chemotherapy and IT immunotherapy (Atezolizumab) which is a standard of care for patients whose tumor express >1% of PD-L1 molecules. T-cell cytokines will be measures prior to treatment and at multiple time points during the treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of metastatic triple negative breast cancer
- •18 years of age or older
排除标准
- •Younger than 18
- •Unwilling to participate or unable to give informed consent
结局指标
主要结局
Progression free survival
时间窗: 12 months
次要结局
未报告次要终点
研究者
Alexander Philipovskiy
Assistant Professor
Texas Tech University Health Sciences Center, El Paso