Liposome-encapsulated Doxorubicin (Myocet) Plus Cyclophosphamide as First or Second Line Therapy for Older Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 64
- 试验地点
- 11
- 主要终点
- Overall Response Rate
研究概览
简要总结
This study will evaluate the efficacy, safety and effect on quality of life of liposomal-encapsulated doxorubicin in combination with cyclophosphamide as first or second line treatment of older patients (≥ 70 years old) with metastatic breast cancer. The efficacy of the combination will be correlated with the functional status of patients according to the comprehensive geriatric assessment
详细描述
Elderly individuals make up a large part of the breast cancer population. When treated with chemotherapy for metastatic disease they derive similar benefits to their younger counterparts. Anthracyclines are associated with a cumulative dose-dependent cardiomyopathy with increased rate in patients over the age of 70. Liposomal-encapsulated doxorubicin improves the therapeutic index of doxorubicin by reducing significantly the cardiotoxicity and grade 4 neutropenia and provides comparable antitumor efficacy, when used in combination with cyclophosphamide as first-line therapy for metastatic breast cancer
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed metastatic breast adenocarcinoma
- •No more than one prior therapy regimen (other than hormonal therapy) for metastatic breast cancer is acceptable.
- •Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
- •Performance status (WHO) 0-2
- •Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases)
- •Adequate renal function (serum creatinine <1.5 times the upper normal limit)
- •Adequate cardiac function (LVEF within normal limits)
- •Adequate bone marrow function (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
- •No radiation of measurable disease (except brain metastases)
- •No progressive brain metastases according to clinical or radiological criteria
- •No brain metastases without prior radiation therapy
- •Written informed consent
排除标准
- •Active infection
- •History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- •Prior treatment with an anthracycline-containing regimen (as adjuvant therapy) during the previous 12 months period
- •Other invasive malignancy except non-melanoma skin cancer
- •Psychiatric illness or social situation that would preclude study compliance
- •Pregnant or lactating women
研究组 & 干预措施
1
Cyclofosfamide/Liposomal-encapsulated doxorubicin
干预措施: Cyclophosphamide (Drug)
1
Cyclofosfamide/Liposomal-encapsulated doxorubicin
干预措施: Liposomal-encapsulated doxorubicin (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Objective responses confirmed by CT or MRI every 3 months
次要结局
- Time to Tumor Progression(1-year)
- Toxicity profile(Toxicity assessment every month)
- Overall Survival(1 year)