EUCTR2006-003993-85-IT进行中（未招募）不适用
Phase II Study of neoadjuvant therapy with trastuzumab plus docetaxel followed by trastuzumab plus pegylated liposomal doxorubicin and cyclophosphamide in human ErbB-2-positive operable or locally advanced breast cancer - CETRA
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE0 个研究点开始时间: 2007年6月13日最近更新:
适应症
相关药物
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
- •? Histologically confirmed HER2-positive (immunohistochemistry [IHC 3+] or fluorescence or chromogenic in situ hybridization [FISH+, CISH+]) breast cancer ? Stage II-IIIB (T0-1-2-3-4-N+-M0, T2-3-4-N0-M0) ? Age ? 18 and < 65 years ? ECOG Performance Status 0-1 ? Life expectancy >3 months ? Neutrophils ? 2 x 109/L and Platelets ?100 x 109/L ? Total bilirubin ?1.25 time the upper-normal limits (UNL) of the Institutional normal values and ASAT (GOT) and/or ALAT (GPT) ? 1.25 UNL. ? Creatinine ? 1.25 the UNL ? Normal Left Ventricular Ejection Fraction (LVEF) >50% (evaluated by MUGA scan or ultrasonography ? only one method must be employed for an individual patient). ? Signed informed consent
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •? Stage IV ? Prior chemotherapy ? History of prior malignancy in the last 10 years (other than non-melanoma skin cancer or excised cervical carcinoma in situ). ? Other serious illness or medical condition ? Congestive hearth failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction, uncontrolled high risk hypertension or arrhythmia ? History of significant neurological or psychiatric disorders including dementia or seizures ? Active infection ? Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening ? Geographic inaccessibility for treatment and follow up ? Pregnant or lactating women
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