NCT00779129已完成2 期
Phase II Trial of Caelyx and Cyclophosphamide 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
- 70
- 主要终点
- Time to response; Duration of response; Time to progression; Survival
研究概览
简要总结
Women with metastatic breast cancer are usually treated with anthracyclines (ie, doxorubicin or epirubicin) but cardiac toxicity limits their use. The aim of this study is to evaluate the safety and efficacy of Caelyx in combination with cyclophosphamide in women with metastatic breast cancer who have received adjuvant anthracyclines with or without a taxane.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged >=18 years.
- •Subject must have histologic diagnosis of breast carcinoma.
- •Subject must have documented measurable metastatic breast cancer by appropriate radiologic imaging.
- •Subject must have previous anthracyclin-based adjuvant regimen and disease-free status for at least one year following the completion of adjuvant therapy.
- •Subject must have ECOG performance status 0, 1, or
- •Subject must have life expectancy > 6 months
- •Subject must have left ventricular ejection fraction >=55% as determined by MUGA scan.
- •Subject must have normal organ function, except if abnormal due to tumor involvement:
- •Adequate bone marrow function (platelets >=100 X 10^9/L, hemoglobin >=90 g/L, Neutrophils >=1.5 X 10^9/L)
- •Adequate renal function (serum creatinine < 2 X the upper limit of normal (ULN)
- •Adequate liver function (bilirubin < 2 times ULN, AST or ALT < 2 times ULN in the absence of liver metastasis, AST or ALT < 5 times ULN in the presence of liver metastasis.
- •Women of childbearing potential must be using adequate contraception and have a negative pregnancy test at the time of enrollment.
- •Subject must be able to understand and give informed consent.
排除标准
- •Age > 75 years old.
- •Subject who is pregnant or breastfeeding or is unwilling to use adequate contraception.
- •Subject who has had a previous chemotherapy for metastatic disease.
- •Subject who has history of cardiac disease, with New York Heart Association Class II or greater with congestive heart failure.
- •Subject who has clinically significant hepatic disease in regard to Hepatitis B, Hepatitis C, cirrhosis, or other liver diseases unrelated to the underlying metastatic breast cancer.
- •Subject who has uncontrolled bacterial, viral, or fungal infection.
- •Subject who exhibits confusion or disorientation.
- •Subject with any condition which would prevent adequate follow-up.
- •Subject who has received radiotherapy in the last 4 weeks.
- •Subject with any other active primary tumor under treatment, except basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
- •Subject who has brain metastasis.
- •Subject who is not able to give informed consent.
研究组 & 干预措施
Single Arm
Experimental
Caelyx 35 mg/m2 and Cyclophosphamide 600 mg/m2
干预措施: Pegylated Lyposomal Doxorubicin (Drug)
Single Arm
Experimental
Caelyx 35 mg/m2 and Cyclophosphamide 600 mg/m2
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Time to response; Duration of response; Time to progression; Survival
时间窗: With complete or partial response, subjects will be re-evaluated 4 weeks later to confirm the initial observation; Follow-up for a minimum of one year for survival.
次要结局
- Left ventricular ejection fraction (LVEF), (MUGA Scan); Radiological imaging; Examination of adverse events, laboratory data, vital signs(LVEF following cycles 2, 4, 5, and 6 of study drug; Radiological imaging every 6 weeks.)
研究者
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