A Prospective, Exploratory Observational Study Evaluating Specific Biomarkers in Primary Invasive Breast Cancer and Their Modulation by Standard Neoadjuvant Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- The presence of a specific predictive gene expression signature in tumor tissues
研究概览
简要总结
This study will examine specific biomarkers in primary invasive breast cancer and explore their correlation with patient outcome following standard neoadjuvant treatment.
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
- •The patient has 18 years of age or older at the time of consent.
- •The patient has provided pre-treatment tumor samples for WT1 expression screening and gene expression profiling in the context of the NCT01220128 study.
- •The patient has a histologically or cytologically confirmed primary invasive breast cancer.
- •The patient has provided written informed consent before any new information or new material is provided to the Sponsor.
- •The patient is planned to receive, is receiving or has received standard and/or investigational therapy for breast cancer.
- •The patient is planned to receive, is receiving or has received standard and/or investigational therapy for breast cancer.
排除标准
- •Not applicable.
结局指标
主要结局
The presence of a specific predictive gene expression signature in tumor tissues
时间窗: At randomization and at definitive surgery which may be up to 30 weeks post randomization.
The presence of other candidate biomarkers in tumor tissues
时间窗: At randomization and at definitive surgery which may be up to 30 weeks post randomization.
Disease free interval
时间窗: Time from definitive surgery to the date of first recurrence of the disease up to maximally 6 years.
The presence of immune infiltration in tumor tissues
时间窗: At randomization and at definitive surgery which may be up to 30 weeks post randomization.
The pathological response (complete response or partial response) in the breast.
时间窗: At definitive surgery which may be up to 30 weeks post randomization.
Disease free survival
时间窗: Time from definitive surgery to either the date of first recurrence of the disease or the date of death (whatever the cause), whichever occurs first, up to maximally 6 years.
Overall survival
时间窗: Time from definitive surgery to the date of death, irrespective of the cause of death. Patients still alive will be censored at the date of the last contact up to maximally 6 years.
次要结局
未报告次要终点