NCT01210768Unknown2 期
A Phase II Randomized Study of Pegylated Liposomal Doxorubicin, Cyclophosphamide Versus Epirubicin-Cyclophosphamide as Adjuvant Chemotherapy in Her2-negative Stage I and II Breast Cancer Patients
TTY Biopharm9 个研究点 分布在 1 个国家目标入组 254 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 254
- 试验地点
- 9
- 主要终点
- Disease-free survival
研究概览
简要总结
Primary objective:
- To evaluate the disease-free survival (DFS) in the two randomized arms after therapy with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer
Secondary objectives:
- To assess the overall survival (OS)
- To establish the safety profile by assessing the toxicities and tolerability
- To assess the quality of life (QoL)
- To evaluate survival correlation with biomarkers expression.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed invasive, but non-inflammatory, breast adenocarcinoma with stage I or II (if N0, T must be >1cm) disease
- •Her2-negative on fluorescence in situ hybridization (FISH) study
- •performance status of ECOG 0, 1
- •female, age between 20 and 70 years
- •life expectancy of at least one year
- •ability to understand and willingness to sign a written informed consent document
排除标准
- •Her2 3+ over-expression on immunohistochemistry (IHC), or Her2 amplification on fluorescence in situ hybridization (FISH) study
- •previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, unless there has been a disease-free interval of at least 5 years
- •Patients who have received prior chemotherapy
- •inadequate hematological function defined as absolute neutrophil count (ANC)less than 1,500/mm3, and platelets less than 100,000/mm3
- •inadequate hepatic function defined as: serum bilirubin greater than 1.5 times the upper limit of normal range (ULN) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN
- •inadequate renal function defined as serum creatinine greater than 1.5 times the ULN
- •left ventricular ejection fraction (LVEF) < 50% confirmed by multiple-gated acquisition (MUGA) scan or echocardiogram
- •concomitant illness that might be aggregated by chemotherapy or interfere study assessment. For examples, active, non- controlled infection (such as hepatitis B and hepatitis C, HIV, infectious tuberculosis) or other active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia, unstable diabetes mellitus, and active peptic ulcer
- •patients who are presence of liver cirrhosis or are HBV/HCV carrier
- •participation in another clinical trial with any investigational drug within 30 days prior to entry
- •pregnant or breast feeding women
- •fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period and for three months following cessation of treatment
研究组 & 干预措施
EC
Active Comparator
Cyclophosphamide,600 mg/m2 q3wk and Epirubicin,90 mg/m2 q3wk
干预措施: Epirubicin+Cyclophosphamide (Drug)
LC
Experimental
liposomal doxorubicin, 37.5 mg/m2 q3wk, and Cyclophosphamide,600 mg/m2 q3wk
干预措施: liposomal-doxorubicin+Cyclophosphamide (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 5 years
To evaluate the disease-free survival (DFS) in the two randomized arms after therapy with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer
次要结局
- Safety profiles(5 years)
- Overall survival(5 years)
- Survival correlation with biomarkers expression(At approximately of 5 years maximum FU)
- Quality of life(Baseline and every 3 weeks during therapy)
研究者
研究点 (9)
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