Vinorelbine Metronomic Plus Bevacizumab as Salvage Therapy for Patients With Metastatic Breast Cancer. A Multicenter Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 9
- 主要终点
- Response rate
研究概览
简要总结
To evaluate the efficacy of metronomic oral vinorelbine taken three times a week without break plus bevacizumab as salvage treatment in patients with metastatic breast cancer.
详细描述
Continuous administration of oral vinorelbine, given three times a week (metronomic) is feasible and exceptionally well tolerated at doses up to 50 mg. Early results show activity against refractory tumors and provide evidence towards clinical proof of efficacy for metronomic chemotherapy. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
- •At least one previous chemotherapy regimen for metastatic breast cancer
- •Age 18-75 years
- •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 function(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) and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
- •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
- •Patient unable to take oral medication
- •Active infection
- •History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- •History of stroke
- •Anticoagulation therapy (except of low dose aspirin <325mg)
- •Other invasive malignancy except nonmelanoma skin cancer
- •Psychiatric illness or social situation that would preclude study compliance
- •Pregnant or lactating women
研究组 & 干预措施
1
Vinorelbine metronomic + bevacizumab
干预措施: Vinorelbine (Drug)
1
Vinorelbine metronomic + bevacizumab
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Response rate
时间窗: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
次要结局
- Progression free survival(1 year)
- Duration of response(1 year)
- Overall survival(1 year)