Vinorelbine Metronomic Plus Lapatinib as Salvage Therapy for Patients With Overexpressing HER-2 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
- 16
- 试验地点
- 2
- 主要终点
- Overall response rate
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of metronomic oral vinorelbine taken three times a week plus daily lapatinib without break, 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, lapatinib plus capecitabine was proven superior to capecitabine alone in women with HER2-positive advanced breast cancer that has progressed after treatment with regimens that included an anthracycline, a taxane, and trastuzumab.
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
- •Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
- •Age 18-75 years
- •HER2 status positive according to the local institution reported grade 3+ staining intensity (on a scale of 0 to 3) by means of immunohistochemical analysis or grade 2+ staining intensity by means of immunohistochemical analysis with gene amplification on fluorescence in situ hybridization
- •Previous therapies had to include, regimens containing an anthracycline and a taxane
- •Previous treatment with trastuzumab, alone or in combination with chemotherapy for locally advanced or metastatic disease, is required
- •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); 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)
- •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/Lapatinib
干预措施: Vinorelbine (Drug)
1
Vinorelbine metronomic/Lapatinib
干预措施: Lapatinib (Drug)
结局指标
主要结局
Overall response rate
时间窗: 3 - 6 month
次要结局
- Quality of life assessment(42 days)
- Progression Free Survival(1 year)
- Toxicity profile(21 days)
- Overall Survival(1 year)
研究者
Vassilis Georgoulias, MD
MD
University Hospital of Crete