NCT04278469招募中不适用
A Prospective, Randomized, Comparative Study to Evaluate Efficacy of Anticancer Chemotherapy in Predicting Prognosis and Determining Chemotherapy Method in Early Hormone Receptor-positive Breast Cancer Patients With Clinicopathological High Risk and GenesWell™ BCT Low Risk at Multi-center in Korea
Gencurix, Inc.1 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2019年1月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- 10-year distant metastasis free survival
研究概览
简要总结
A prospective, randomized, comparative study to evaluate efficacy of anticancer chemotherapy in predicting prognosis and determining chemotherapy method in early Hormone Receptor-positive breast cancer patients with clinicopathological high risk and GenesWell™ BCT low risk at multi-center in Korea
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women aged 19-80 at screening
- •Histologically invasive carcinoma
- •Hormone receptor positive (Estrogen, ER+ and/or Progesterone, PR+)
- •Human epidermal growth factor receptor 2 negative (HER2-)
- •Axillary lymph node assessment: pN0 or pN1
- •Tumor size≥0.5cm
- •Clinical high risk (based on modified Adjuvant! Online)
- •Patients who agree to genetic testing
- •Patients who have adequate organ function
- •Genomic low risk (based on GenesWell BCT)
- •De novo primary cancer
- •Patients how performed surgery with curative aim
- •Patients who have provided written informed consent themselves
排除标准
- •Hormone receptor negative (Estrogen, ER- and Progesterone, PR-)
- •Human epidermal growth factor receptor 2 positive (HER2+)
- •Axillary lymph node assessment: pN2 or pN3
- •Patients who are received chemotherapy prior to operation
- •Patients who are received radiotherapy prior to operation
- •Tumor size<0.5cm
- •Clinical low risk
- •FFPE tumor sample is not available
- •Patients with following conditions:
- •Patient with chronic liver disease
- •Patient with cerebrovascular disease
- •Patient with chronic mental disorder
- •Pregnant women, women of childbearing potential or lactating women
- •Patients who are deemed inappropriate as study participants by investigators
- •Patients with recurrent breast cancer or treatment history of breast cancer
- •Patients who have not undergone surgery
研究组 & 干预措施
Patients with chemotherapy
Active Comparator
干预措施: Chemotherapy Drugs, Cancer (Drug)
结局指标
主要结局
10-year distant metastasis free survival
时间窗: up to 10 years
To evaluate 10-year distant metastasis free survivals according to adjuvant chemotherapy in patients with clinical high and genomic low risk
次要结局
- disease free survival(up to 10 years)
- overall survival(up to 10 years)
研究者
研究点 (1)
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