Metastatic breast cancer MedDRA version: 9.1 Level: LLT Classification code 10055113 Term: Breast cancer metastatic
Conditions
Interventions
Trade Name: TAXOTERE*INFUS FL 20MG/0,5ML+F
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Docetaxel
Concentration unit: mg/ml milligram(s)/millilitre
Concentration typ
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients (female) with documented advanced/metastatic breast cancer without HER-2/neu over expression ( IHC 3+ or FISH positive) Patients may not have received a previous chemotherapy regimen for metastatic breast cancer Patients may have received previous hormonal treatment for endocrine responsive metastatic disease. Patients may have received chemotherapy with taxanes as adjuvant treatment provided that metastatic disease occurred at least 6 months after the completion of adjuvant chemotherapy. 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 who have received: - 1 or more regimens of chemotherapy for metastatic disease; - taxanes in the adjuvant setting < 6 months from study entry Patients with HER2 overexpressing metastatic breast cancer Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel Presence of known clinical brain or meningeal involvement. Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient; Concomitant treatment with other anticancer (chemotherapy or endocrine therapy) drugs. Concomitant treatment with any other experimental drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the overall response rate, according to RECIST criteria To determine the overall survival (OS);Secondary Objective: To assess time to progression disease (TTP) To determine the duration of response (DR).To assess toxicity (adverse events) and QoL To investigate the predictive and prognostic value of serum CTCs levels on clinical outcome;Primary end point(s): To assess the overall response rate, according to RECIST criteria To determine the overall survival (OS) | — |
Countries
Italy
Outcome results
None listed