NCT02142790Unknown4 期
Weekly and Every 3 Week Administration of Paclitaxel Liposome Injection in Metastatic Breast Cancer
Nanjing Luye Sike Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年5月最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This is a open-label study in patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense paclitaxel liposome injection compared to 3-weekly regimen.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or Male >18 years of age and < 70years of age, If female of childbearing potential, pregnancy test is negative before first dose of study drug and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
- •Stage IV disease
- •Measurable disease
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Suitable for the treatment with paclitaxel as single agent regimen (first line or prior first line chemotherapy including adriamycin is allowed, If a taxane was part of the adjuvant regimen, at least one year should have transpired since completion of taxane regimen and if Her2+ patient, Herceptin therapy will be allowed.
- •Patient has the following values at Baseline: Absolute neutrophil count ≥ 1.5 x 10^9cells/L; platelets ≥ 100 x 10^9 cells/L; hemoglobin ≥ 10 g/dL. Aspartate transaminase (AST or SGOT), alanine aminotransferase (ALT or SGPT) ≤ 2.5x upper limit of normal range (ULN); total bilirubin ≤ 1.5ULN; creatinine ≤ 1.5 mg/dL.
- •Informed consent has been obtained.
排除标准
- •Parenchymal brain metastases.
- •History of other malignancy within the last 3 years
- •New York Heart Association (NYHA) Grade 2 or greater congestive heart failure,history of myocardial infarction or unstable angina or new occured angina within 6 months prior to study enrollment.
- •Concurrent other anticancer therapy.
- •History of serious organic disorders (including active infection or Cardiovascular disease), serious hepatic disease, serious blood coagulation diseases, cachexia
- •Sensory neuropathy of > Grade 1 at baseline.
- •Patients with prior hypersensitivity to paclitaxel
- •Pregnant or nursing women
- •enrolled in a different clinical study
- •No psychiatric illness and other situations that would limit compliance of study
研究组 & 干预措施
paclitaxel liposome injection weekly
Experimental
paclitaxel liposome injection 100mg/m2 administered by intravenous on day1 and day8 of a 21-day cycle for at least 4cycles or till progression or intolerable
干预措施: paclitaxel liposome injection (Drug)
paclitaxel liposome injection every 3 weeks
Experimental
paclitaxel liposome injection 175mg/m2 administered by intravenous on day1 of a 21-day cycle for at least 4cycles or till progression or intolerable
干预措施: paclitaxel liposome injection (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: 24 months
次要结局
- Clinical Benefit Rate(24 months)
- Overall Response Rate(24 months)
- Adverse Events(24 months)
研究者
研究点 (1)
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