NCT00431795终止2 期
A Multicenter Randomized Phase II Study of Second Line Chemotherapy With Epirubicin( Farmorubicin) Versus the Pegylated Liposomal Doxorubicin in Advanced Breast Cancer Patients
Hellenic Oncology Research Group10 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2003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
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Assessment of antitumor efficacy by objective tumor response rates
研究概览
简要总结
DOXORUBICIN is recognized as one of the most active drugs for breast cancer, but its clinical utility is limited because of a cumulative dose-dependent cardiac myopathy that can lead to potentially fatal congestive heart failure. Caelyx (pegylated liposomal doxorubicin) was designed to reduce the cardiotoxicity of doxorubicin while preserving its antitumor efficacy
详细描述
To compare the efficacy of pegylated liposomal doxorubicin versus epirubicin as second line chemotherapy in patient with advanced 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Adequate bone marrow function (Absolute neutrophil count >1000/mm^3, Platelet count>100000/mm^3, Hemoglobin>9gr/mm^3)
- •Histologically- or cytologically- confirmed breast adenocarcinoma
- •No prior anthracycline-based chemotherapy as treatment of advanced breast cancer
- •No prior chemotherapy with ≥ 300mg/m2 doxorubicin or ≥ 540mg/m2 epirubicin as adjuvant setting
- •At least 4 weeks interval since prior anticancer treatment
- •Measurable disease as defined by the presence of at least one measurable lesion(except bone metastases, ascites or pleural effusions)
- •Life expectancy > 3 months
- •Written informed consent
排除标准
- •Pregnancy or nursing
- •Documented history of congestive heart failure (CHF), serious arrhythmia, or myocardial infarction (within 6 months)
- •Other invasive malignancy except nonmelanoma skin cancer or acute infection.
- •Radiation of measurable disease (except brain metastases)
- •Progressive brain metastases according to clinical or radiological criteria.
- •Brain metastases without prior radiation therapy
研究组 & 干预措施
1
Experimental
Epi
干预措施: Epirubicin (Drug)
2
Experimental
Cael
干预措施: Pegylated liposomal doxorubicin (Caelyx) (Drug)
结局指标
主要结局
Assessment of antitumor efficacy by objective tumor response rates
时间窗: Objective responses confirmed by CT or MRI (on 3rd and 6th cy)
次要结局
- Overall survival(1 year)
- Time to progression(1 year)
- Toxicity profile and tolerance between the two treatment arms(Toxicity assessment of each chemotherapy cycle)
研究者
研究点 (10)
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