Phase II study of liposomal doxorubicin in combination with trastuzumabplus cyclophosphamide followed by docetaxel plus trastuzumab as primary systemic therapy for patients with locally advanced breast cancer with HER2 overexpression or amplification. - MYETT

S.I.C.O.G. ONLUS0 个研究点目标入组 41 人开始时间: 2013年10月30日最近更新: 2018年2月26日

适应症

试验速览

暂无简介。

•HER2-positive (immunohistochemistry (IHC 3 +) or amplification detected by fluorescence in situ hybridization [FISH +])
•-Performance status ECOG 0-1
•-Life expectancy> 3 months
•-Neutrophils = 1.5 x 10 9 / L and PLatelets = 100 x 10 9 /L
•-Total bilirubin = 1.5 times upper normal limit (UNL) of the Centre
•-ASAT (GOT) and / or ALT (GPT) = 2.5 UNL
•-Alkaline phosphatase = 5 UNL (unless they are bones metastases in the absence of any liver disease. Patients with AST and / or ALT> 1.5 x UNL associated with alkaline phosphatase > 2.5 xUNL are not eligible in the study
•-Creatinine within normal institutional limit
•-Ventricular ejection fraction (LVEF) = 55% (assessed by MUGA scan or ultrasound - only one method should be used for each patient)
•-Written 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 41
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 41

•-absence of Written informed consent
•-Previous chemotherapy
•-History of cancer in the previous 10 years (except skin cancer,non-melanoma,cervical carcinoma in situ excised)
•-Other serious illnesses
•-Congestive heart failure or angina pectoris even if controlled, previous history of myocardial infarction, uncontrolled hypertension, or arrhythmia.
•-History of neurological or psychiatric disorders including dementia and epilepsy.
•-Active Infection
•-Treatment with other experimental drugs
•-Geographical inaccessibility for treatment and follow-up
•-Women who are pregnant or lactating

发起方

S.I.C.O.G. ONLUS