Breast Cancer MedDRA version: 12.1 Level: LLT Classification code 10057654 Term: Breast cancer female
Conditions
Interventions
Trade Name: HERCEPTIN*EV 1FL 150MG
Pharmaceutical Form: Emulsion for infusion
INN or Proposed INN: Trastuzumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Sponsors
AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent (approved by the Ethics Committee) is obtained before any procedure studiospecifica. - Age: 18-70 years - Ability to adhere to the procedures of the Protocol - Women with breast cancer, histologically or cytologically documented HER2-positive in the pre-or post-menopausal, with disease radically operated, loco-regional relapse with locally advanced disease, with metastatic disease who will receive Herceptin as provided the Summary of Product Characteristics. - Performance status (PS), according to the Eastern Cooperative Oncology Group (ECOG): 0-2. - Value of LVEF> 55% - A previous radiation therapy is allowed if administered in the adjuvant setting as an integrated treatment of early stage breast cancer provided they did not result in heart damage documented by an assessment instrument. - Adequate bone marrow function (absolute neutrophil de = 1.5x109 / L, platelet count = 100x109 / L, hemoglobin = 9 g / dl) - Adequate liver function (total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Diagnosis of pharmacologically uncontrolled arterial hypertension (systolic> 150mmHg and / or diastolic> 100mmHg). - Diabetes mellitus type 1-2 is not controlled pharmacologically (fasting blood glucose> 250mg/dl). - Uncontrolled Hypercholesterolemia (> 300mg/dl), uncontrolled hypertriglyceridemia (> 300mg/dl) - Patients carriers of a pacemaker or heart valve - Diagnosis of chronic atrial fibrillation or paroxysmal atrial fibrillation - Significant cardiovascular disease (active), such as acute cerebrovascular accident (6mesi prior to enrollment), myocardial infarction (6 months prior to enrollment), unstable angina, congestive heart failure (class II according to the NYHA). - Treatment with any investigational agent, or participation in another clinical trial in 28giorni preceding enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Evaluate the predictive significance of early cardiac damage found to TDI (demonstrating a correlation between heart damage and possible early onset of clinically significant cardiac damage in patients in follow-up);Primary end point(s): identify the changes of cardiac parameters (TDI)), in particular, and SR Strain, and laboratory abnormalities predictive of cardiac damage to TDI.;Main Objective: Evaluate the early cardiac damage induced by Trastuzumab TDI technique in patients with metastatic breast HER-2 positive. - Analyze the correlation between the alterations observed instrumental to TDI, and changes in circulating levels of biochemical markers of cardiac damage and parameters of chronic inflammation and oxidative stress - | — |
Countries
Italy
Outcome results
None listed