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

Conditions: Females with metastatic breah cancer with her2 receptor overexepression and PERFORMANCE STATE-PS ECOG from 0 to 2
MedDRA version: 6.1Level: PTClassification code 10055113

Registration Number: EUCTR2006-000413-37-IT

Lead Sponsor: AZIENDA UNITA SANITARIA LOCALE N 12 DI VIAREGGIO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Overall response rate ORR and clinical benefit ORR SD 6 mesi Tolerability;Secondary Objective: Time to progression -TP Overal Survival -OS Quality of life;Primary end point(s): Overall response rate ORR and clinical benefit ORR SD 6 mesi Tolerability

Secondary Outcome Measures