Oncologic patients only. MedDRA version: 6.1 Level: PT Classification code 10055113
Conditions
Interventions
Trade Name: GEMZAR*1FL 200MG POLV
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Gemcitabine
CAS Number: 122111-03-9
Concentration unit: mg milligram(s)
Concentratio
Sponsors
A.S.L. 2 SAVONA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed