Clinical trial phase IV, prospective, non-randomized, for the evaluation of myocardial dysfunction early predictor of clinically significant cardiac damage induced by Herceptin in women with HER2 positive breast cancer (adjuvant and metastatic setting) and its correlation with markers organic heart damage, chronic inflammation and oxidative stress. - ND
- Conditions
- Breast CancerMedDRA version: 12.1Level: LLTClassification code 10057654Term: Breast cancer female
- Registration Number
- EUCTR2010-019195-67-IT
- Lead Sponsor
- AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
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 <1.5volte the upper limit of normal (ULN, AST, ALT <2.5xULN)
- Adequate renal function (serum creatinine = 1.25xULN)
- Women not pregnant or lactating
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>- 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<br>-
- Secondary Outcome Measures
Name Time Method