NCT00903656终止2 期
Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy - a Phase II Study
Arbeitsgemeinschaft medikamentoese Tumortherapie1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Efficacy of a Lapatinib plus Caelyx combination regimen in the treatment of advanced metastatic breast cancer, in terms of overall response rates (complete or partial response)determined by RECIST
研究概览
简要总结
The aim of this study is to evaluate the potential of a Lapatinib plus Caelyx combination therapy as an effective and safe therapeutic regimen with a favourable cardiotoxicity profile, in the treatment of metastatic breast cancer following failure of prior trastuzumab.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female patients, age ≥ 18 years
- •Advanced or metastatic breast cancer, histologically confirmed
- •Documented HER2 overexpression (IHC 3+ and/or FISH positive)
- •At least one measurable lesion according to RECIST criteria. Patients with bone-only lesions are not eligible for study entry
- •Documented disease progression
- •Patients may have no more than 1 line of palliative treatment, however prior therapies must include trastuzumab in adjuvant or metastatic setting
- •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
排除标准
- •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
- •Positivity for HIV, Hepatitis B or C
- •History of other malignancy; patients who have been disease-free for 5 years
- •Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy) or concurrent treatment with an investigational drug or participation in another clinical trial
- •Known hypersensitivity to the study drugs Lapatinib and Caelyx or their excipients
研究组 & 干预措施
Caelyx/Lapatinib
Experimental
干预措施: doxorubicinhydrochloride, Lapatinib (Drug)
结局指标
主要结局
Efficacy of a Lapatinib plus Caelyx combination regimen in the treatment of advanced metastatic breast cancer, in terms of overall response rates (complete or partial response)determined by RECIST
次要结局
- Overall survival, progression free survival, clinical benefit (CR, PR or stable disease for at least 24 weeks)
- Quality of Life
- Safety profile
- Occurrence of clinically apparent brain metastases
研究者
研究点 (1)
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