PATIENTS WITH BREAST CANCER OPERATED HER-2 MedDRA version: 6.1 Level: PT Classification code 10057654
Conditions
Interventions
Product Name: Trastuzumab
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Trastuzumab
CAS Number: 180288-69-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female gender Age 61619; 61472;18 years Eastern Cooperative Oncology Group ECOG performance status 1 Signed written informed consentE Overexpression of HER2 in the invasive component of the primary tumor, according to one of the following definitionsD - 3 overexpression by IHC - 2 overexpression by IHC AND fluorescence in situ hybridisation FISH test PathVysion or INFORM 61650; 61472;HER-2/neu demonstrating C-erbB2 gene amplification ratio of c-erbB2 gene signals to centromere 17 signals 2 - c-erbB2 gene amplification by FISH ratio of c-erbB2 gene signals to centromere 17 signals 2 Completion of adjuvant chemotherapy and radiotherapy for all patients undergoing radiotherapy Adequate bone marrow, liver and renal functions Baseline LVEF 55 measured by echocardiography or MUGA scan 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: Metastatic breast carcinoma Pregnant or lactating women Other serious cardiac illness or medical condition A including but not confined to o History of documented congestive heart failure CHF o High-risk uncontrolled arrhythmias o Angina pectoris requiring antianginal medication o Clinically significant valvular heart disease o Evidence of transmural infarction on ECG o Poorly controlled hypertensionF e.g. systolic 180mm Hg or diastolic greater than 100mm Hg Baseline LVEF 55 measured by echocardiography or MUGA scan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and cardiotoxicity of disease-free survival DFS to 2-3-4-5 end 10 years;Secondary Objective: COMPARING TO OTHER CONTROLLED CLINICAL TRIALS ACTIVATED IN INSTITUTE MIG 1 E MIG 5 ;Primary end point(s): EFFICACY IN TERMS OF FOR PATIENTS DISEASE FREE AT 2-3-4-5-AND 10 YEARS | — |
Countries
Italy
Outcome results
None listed