iposomial pegylate doxorubicine and trasuzumab in the first line treatment of the metastatised Her2 positive breast cancer for senior women - ND
- Conditions
- Metastased breast cancer, first line treatment, for women with age>70 years old,Her2 positiveMedDRA version: 9.1Level: LLTClassification code 10006279Term: Breast neoplasm
- Registration Number
- EUCTR2006-007089-12-IT
- Lead Sponsor
- GOIM GRUPPO ONCOLOGICO MERIDIONALE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Breast cancer istologically assured, age>70 years old, validity state (WHO)< o = 2, desease at IV stage with one misurable unidimensionally lesion.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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 chemoteraphy for metastatic desease, concomitant serious deseases(cardiovascular, renal, hepatic,etc.), cardiopathy pre-existing with cardiac insufficiency
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To consider the activity of the chemoteraphic combination with the percentage of obiective responses;Secondary Objective: To consider the toxicity of the treatment, in particular the cardiac toxicity, to consider the progression time and global survival, to consider the reduction of the hospital costs;Primary end point(s): To consider the efficacy and the tolerability of the chemoteraphic combination
- Secondary Outcome Measures
Name Time Method