trastuzumab, docetaxel and oxaliplatino association in metastatic breast cancer with her2 receptor overexepression Phase II clinical trial - HOT

AZIENDA UNITA SANITARIA LOCALE N 12 DI VIAREGGIO0 个研究点目标入组 50 人开始时间: 2006年6月5日最近更新: 2012年4月3日

试验速览

暂无简介。

•Histological diagnosis of breast cancer - HER2 overexpression immune histological determination with positivity score 3 or 2 FISH confirmed - Instrumental evidence for metastatic diffusion measurable disease; RECIST parameters - Patients aged 18 to 70 years - PS ECOG between 0 and 2 - Life expectancy 6 months - Adequate bone marrow functionality leucocytes 8805; 3.0 109/L, neutrophils 1.5 109/L, platelets 8805; 100 109/L, haemoglobin 9g/dl - Adequate hepatic functionality total bilirubin 8804; 1.25 x UNV, transaminase 8804;3 x UNV, alkaline phosphatase 8804;2.5xUNV - Adequate renal functionality creatinine 8804;1.3 x UNV - Cardiac ejection fraction equal at least to 50 - Any concluded adjuvant or metastatic disease hormonal treatment has admitted - Premenopausal women using effective methods off birth controll and negative pregnancy test on 2 weeks before chemotherapy s beginning - 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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Previous chemotherapy treatment for metastatic disease - Previous treatment with Docetaxel in adjuvant or neoadjuvant therapy - Presence of symptomatic cerebral metastases - Radiotherapy on only valutation target - Acute myocardial infarction during the last year - Adequate follow up no possible - no compensate metabolic diseases or infection in act - arithmin cardiac or no control cardiopathic ischemia - Pregnant patients

发起方

AZIENDA UNITA SANITARIA LOCALE N 12 DI VIAREGGIO