oncological patients only MedDRA version: 6.1 Level: PT Classification code 10055113
Conditions
Interventions
Pharmaceutical Form: Emulsion for infusion
INN or Proposed INN: Docetaxel
CAS Number: 114977-28-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Sponsors
A.S.L. 2
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed