apatinib plus Caelyx in patients with advanced metastatic breast cancer following failure of Trastuzumab therapy – a Phase II study - Caelyx/Lapatinib

Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH0 个研究点开始时间: 2009年2月16日最近更新: 2012年8月14日

适应症

试验速览

暂无简介。

•Advanced or metastatic breast cancer, histologically confirmed
•Documented HER2 overexpression (IHC 3+ and/or FISH positive)
•Documented disease progression
•Patients that are progredient after Trastuzumab therapy (palliative or adjuvant)
•Life expectancy of at least 12 weeks
•Performance status 0-1
•Cardiac ejection fraction >= 50% as measured by echocardiogram or MUGA scan
•Adequate hematology, liver and renal function:
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Pregnant or lactating women
•Serious medical or psychiatric disorders that would interfere with the patient’s safety or informed consent
•Severe cardiac disease (uncontrolled angina, arrhythmia, chronic heart failure (CHF) or cardiac disease requiring a device)
•Ejection fraction below the institutional normal limit
•Maximum cumulative dose of 360 mg/m2 for doxorubicin and 720 mg/m2 for epirubicin
•Active bacterial, viral or fungal infection
•Patients with clinically apparent brain metastases
•Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy) or concurrent treatment with an investigational drug or participation in another clinical trial
•Radiation of the target lesion within the last 4 weeks before study entry

发起方