Phase II study with gemcitabine/docetaxel fist line in women with metastatic breast cancer. - SF2gem/tax
- Conditions
- Oncologic patients only.MedDRA version: 6.1Level: PTClassification code 10055113
- Registration Number
- EUCTR2006-000165-10-IT
- Lead Sponsor
- A.S.L. 2 SAVONA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 70
Metastatic brast cancer adgiuvant treatment with antracicline and treatment with taxans endend least one year before yeras 18 75 ps 2 regular functionality of the liver, hepatic and cardiac informed consent written women fertile age must to use contracceptive to warrant cover 99
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
patient teated before with chemioterapy for metastatic breast cancer previous neoplasm excepts cutaneos and cervix in situ carcinoma pregnansy crerebri metastasy radioterpy on single valuable lesion HERB2/neupos 3 IHC or FISH psichiatrics diseases to obstacle writtent consens only bone metastasis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: activity of chemioterapic regiment Docetaxel 50 mg/m2 e.v. g 1,15 q 28 Gemcitabina 1250 mg/m2 e.v. g 1,15 q 28 firt line in metastatic of breast cancer;Secondary Objective: toxicity, pacticability to value prognosis;Primary end point(s): of objective response
- Secondary Outcome Measures
Name Time Method