NCT03295552终止2 期
Decitabine Plus Carboplatin in the Treatment of Metastatic Triple Negative Breast Cancer
Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年11月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
To evaluate the effect of novel DNA demethylating agents in the treatment of metastatic TNBC
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged between 18 years and 70 years old.
- •Pathologically confirmed metastatic triple negative breast cancer (TNBC). Paraffin-embedded tissue were available from metastatic or primary sites to confirm its TNBC status or for further translational research. TNBC was defined as ER-, PR-, and HER2-.
- •Metastatic TNBC should not be treated with more than 1-line for metastatic disease.
- •Patients can not be treated with carboplatin in the metastatic setting.
- •For patients received carboplatin treatment in the adjuvant setting, they should have at least one year disease interval between last dosage of carboplatin and trial recruiting.
- •Patients had at least one measurable lesion according to RECIST criteria version 1.
- •ECOG Performance Status (PS) of 0-
- •Adequate liver and renal organ function.
- •Dated and signed IEC/IRB-approved informed consent.
排除标准
- •More than 1 one therapy for metastatic TNBC, Patients may receive bisphosphonates and other therapies to treat bone metastases.
- •Less than four weeks since last radiotherapy.
- •Pregnancy or lactation or unwillingness to use adequate method of birth control.
- •Active or uncontrolled infection.
- •Hypersensitivity to carboplatin or decitabine
- •Male breast cancer.
- •Treated with any DNA demethylating agents
- •Young patients with pregnancy or lactation or unwillingness to use adequate method of birth control.
研究组 & 干预措施
DC
Experimental
DNA demethylating agent decitabine plus carboplatin
干预措施: Decitabine (Drug)
DC
Experimental
DNA demethylating agent decitabine plus carboplatin
干预措施: Carboplatin (Drug)
结局指标
主要结局
Overall response rate
时间窗: At the end of Cycle 6 (each cycle is 21 days)
Partial response (PR) + complete response (CR) rate
次要结局
未报告次要终点
研究者
Kunwei Shen
Professor
Shanghai Jiao Tong University School of Medicine
研究点 (1)
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