NCT01069081已完成2 期
Phase II Study of Docetaxel and Cisplatin Chemotherapy Versus Docetaxel and Cisplatin Chemotherapy Combined With High Dose Proton Pump Inhibitor in Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Time to progression
研究概览
简要总结
The objectives of this study are to evaluate the efficacy and tolerability of high dose proton pump inhibitor combined with chemotherapy in metastatic breast cancer.
详细描述
High dose proton pump inhibitor (PPI) has been proved beneficial and it improved efficacy when combined with chemotherapy in preclinical and clinical trials.This study was designed to explore whether adding a proton pump inhibitor into docetaxel and cisplatin chemotherapy improves efficacy and does not affect tolerability in metastatic breast cancer.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Female, ≥ 18 years.
- •Histologically confirmed invasive breast cancer.
- •Metastatic breast cancer.
- •Karnofsky Performance Status ≥
- •Life expectancy of more than 3 months.
- •Subject must have adequate organ function.
- •Normal laboratory values: hemoglobin > 80g/dl, neutrophils > 2.0×10^9/L, platelets > 80×10^9/L, serum creatinine < upper limit of normal (ULN), serum bilirubin < ULN, ALT and AST < 2.5×ULN, AKP < 5×ULN.
- •Negative serum pregnancy test for women with childbearing potential.
- •Good conditions for infusion and willing to have phlebotomy throughout whole study.
- •Have ceased anti-tumor treatments including endocrinotherapy and bio-targeted therapy for more than 28 days.
- •Have at least one target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- •No prior use of docetaxel or has used docetaxel in adjuvant/neo-adjuvant chemotherapy and has a relapse free survival of at least 12 months.
排除标准
- •Pregnant or lactating females.
- •History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
- •Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety.
- •Active or uncontrolled infection.
- •Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
- •Concomitant with brain metastases.
- •Have received chemotherapy after metastasis.
研究组 & 干预措施
arm A
Active Comparator
docetaxel and cisplatin chemotherapy
干预措施: Arm A (Drug)
arm B
Experimental
docetaxel and cisplatin chemotherapy combined with PPI 160mg per day.
干预措施: Arm B (Drug)
arm C
Experimental
docetaxel and cisplatin chemotherapy combined with PPI 200mg per day.
干预措施: Arm C (Drug)
结局指标
主要结局
Time to progression
时间窗: six weeks
次要结局
- Time to treatment failure,Objective response,Overall survival,Safety(six weeks)
研究者
研究点 (1)
Loading locations...
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