EUCTR2007-005400-40-GR进行中（未招募）不适用
A pilot feasibility study to evaluate the efficacy of lapatinib in eliminating cytokeratin-positive tumor cells circulating in the blood of women with brest cancer
Vassilis Georgoulias, Prof. of Internal Medicine-Oncology of Medical Dpt University of Crete0 个研究点开始时间: 2008年3月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Provision of written informed consent
- •2.Histologically or cytologically confirmed breast cancer
- •3.Metastatic breast cancer (stage IIIB and IV). EGFR and/or HER-2 expression on the primary tumor is not mandatory.
- •4.Patients should have received at least one course of standard systemic chemotherapy for their metastatic disease. Prior hormonal therapy is allowed.
- •5.Patients should have achieved objective response (CR or PR) or stable disease to previous first or second line treatment.
- •6.There should be at least one month between the end of chemotherapy treatment and trial entry. In case of prior Herceptin administration, 3 months are required to have elapsed before study entry.
- •7.Detection of =5 cells/7.5ml of peripheral blood detected by Cell Search System (Veridex) despite the previous administration of chemotherapy and/or hormonal therapy.
- •8.HER-2 expression on CTCs.
- •9.Age 18 years and over Adequate organ function
- •Haematological function:
- •Absolute neutrophil count (ANC) =1.5 x 109/L
- •Platelet count =100 x 109/L and
- •Haemoglobin =9 g/dL (may be transfused to maintain or exceed this level)
- •Liver Function:
- •Total bilirubin <1.5 x upper limit of normal (ULN)
- •AST, ALT <2.5 x ULN in patients without liver metastases; <5 x ULN in patients with liver metastases
- •Renal function:
- •Serum creatinine =1.25 x ULN or calculated creatinine clearance =50 mL/min
- •10.LVEF within institutional normal range
- •11.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2
- •12.Life expectancy of at least 12 weeks
- •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
排除标准
- •1.any concurrent systemic treatment for breast cancer (including chemotherapy, radiotherapy, hormonotherapy, monoclonal antibodies)
- •2.Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •3.Any unresolved chronic toxicity greater than Grade 2 (NCI- CTCAE) from previous anticancer therapy (except alopecia)
- •4.Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- •5.Pregnancy or breast feeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
- •6.Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment
- •7.Known hypersensitivity to drugs chemically related to lapatinib
- •8.Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors.
- •9.Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related
- •10.Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors complications.
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