NCT01617954已完成不适用
PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Agendia
- 入组人数
- 820
- 试验地点
- 53
- 主要终点
- Difference in recommended adjuvant chemotherapy treatment
研究概览
简要总结
This is a prospective study that will assess the impact of MammaPrint on chemotherapy + endocrine versus endocrine alone treatment decisions in patients with an Oncotype Intermediate Score.
详细描述
The frequency of chemotherapy + endocrine versus endocrine alone decisions in Oncotype DX intermediate score patients will be calculated before and after receiving the MammaPrint result.
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 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with histologically proven invasive stage I-II, node negative, hormone receptor positive, Her2 negative breast cancer, who received an Oncotype DX intermediate score (18-30)
- •≥ 18 years of age at time of consent
- •Written informed consent
排除标准
- •Insufficient tissue remaining for Mammaprint FFPE
- •Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
- •Women who have started or completed adjuvant chemotherapy or neo-adjuvant chemotherapy
结局指标
主要结局
Difference in recommended adjuvant chemotherapy treatment
时间窗: 30 days
The frequency of chemotherapy + endocrine versus endocrine alone decisions in Oncotype DX intermediate score patients will be calculated before and after receiving the MammaPrint result. A Chi-square test will be performed for the comparison of the two proportions.
次要结局
未报告次要终点
研究者
研究点 (53)
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