Phase II study with gemcitabine/docetaxel first line in women with metastatic breast cancer - SF- 2Gem/tax
- Conditions
- oncological patients onlyMedDRA version: 6.1Level: PTClassification code 10055113
- Registration Number
- EUCTR2005-006168-71-IT
- Lead Sponsor
- A.S.L. 2
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 70
metastatic breast cancer adjuvant treatment withantracicline and treatment with taxans ended at least one year before years 18 and 75 performance status 2 liver and hepatic normal functionality normal cardiac function informed consent written woman fertile age must use contraceptive to warrant coverage greater than the 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
patients treated with chemioterapy for metastatic breast cancer previous neoplas except cutaneous and cervix in situ carcinoma pregnancy brain metastasis radioterapy on single valuable lesion positivity 3 for HER2/neu with IHC or FISH psichiatrics disease to compromise written informed consens or compliance of the patient patients with only bone metastasis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: toxicity practicability to value prognosis;Primary end point(s): of objective response;Main Objective: activity of chemioterapic regimen Docetaxel 50 mg/m2 e.v. g. 1,15 ogni 28 gemcitabina 1250 mg/m2 e.v. g. 1,15 ogni 28 first line in metastatic breast cancer
- Secondary Outcome Measures
Name Time Method