BREAST CANCER MedDRA version: 23.0 Level: PT Classification code 10065430 Term: HER2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: VASTAREL - 20 MG COMPRESSE RIVESTITE 60 COMPRESSE
Product Name: VASTAREL
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TRIMETAZIDINA DICLORIDRATO
Current Sponsor code: NON D
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients of adult women (> 18 years =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Metastatic disease • Deficit of bone marrow function as assessed by the absolute neutrophil count (ANC) 1.5 mg / dl and alkaline phosphatase, SGOT and SGPT> 2.5 times normal • Previous malignancies undergoing chemotherapy or radiotherapy treatment, other concomitant neoplasms and any underlying medical condition that could make it dangerous to administration of the study drug or obscure the interpretation of results and adverse events • ischemic heart disease diagnosis based on clinical or instrumental (ECG, of inducible myocardial ischemia testing, coronary angiography); previous myocardial infarction; valve disease (stenosis and / or aortic insufficiency or mitral) more severe than mild; congestive heart failure • Non sinus rhythm and / or presence of left bundle branch block on electrocardiogram • Pacemakers • Global longitudinal strain = 160 mmHg and / or diastolic blood pressure (DBP)> = 100 mmHg • kidney failure superior to moderate (creatinine clearance <60 ml / min calculated according to the Cockcroft Gault - Appendix 2) • neurological comorbidities: Parkinson's disease, parkinsonian symptoms, restless legs syndrome and movement disorders • history of substance abuse (alcohol, drugs and / or psychotropic substances) or psychiatric conditions that could limit the ability of the patient to comply with the study or to follow up compliance procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effect of prevention of the decrease in ejection fraction and the changes of global longitudinal strain on ecocardiography (as a marker of preclinical left ventricular dysfunction) by trimetazidine during and after chemotherapy.;Secondary Objective: Evaluate the prevention of myocardial injury by monitoring troponin I and the prevention of heart failure by monitoring the brain natriuretic peptide monitoring (BNP). ;Primary end point(s): Absolute and relative frequency of subjects with onset of cardiotoxicity during the 24-month follow-up, assessed using repeated echocardiograms defined by the criteria of CREC (Cardiac Review and Evaluation Committee of trastuzumab-associated cardiotoxicity):decrease in LVEF of at least 5 points (absolute value) below the cut-off of normal (55%) with signs and symptoms of heart failure or decrease in LVEF of at least 10 points (absolute value) below the cut-off of normal (55%) without signs and symptoms of heart failure;Timepoint(s) of evaluation of this end point: At the end of chemotherapy and the trastuzumab administration and at 12 months from the last cycle of trastuzumab . | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ¿ absolute and relative frequency of early cardiac toxicity during the 24-month follow-up, assessed using the parameter global longitudinal strain (GLS) with the method "speckle tracking echocardiography; ¿ Rate of early cardiotoxicity in 24 months; ¿ Absolute and relative frequency of patients who develop diastolic dysfunction. Diastolic function will be assessed using echocardiograms by parameters such as speed E wave, A wave velocity, E / A ratio, annulus TDI with dimension E ', A', S at septal and lateral wall of the ring mitral and E / E ' ratio. ; ¿ Diastolic dysfunction rate at 24 months; ¿ Time to onset of diastolic dysfunction;Timepoint(s) of evaluation of this end point: At the end of chemotherapy and the trastuzumab administration and at 12 months from the last cycle of trastuzumab .; At the end of chemotherapy and the trastuzumab administration and at 12 months from the last cycle of trastuzumab; At the end of chemotherapy and the trastuzumab administration and at 12 months from the last cycle of trastuzumab; At the end of chemotherapy and the trastuzumab administration and at 12 months from the last cycle of trastuzumab; At the end of chemotherapy and the trastuzumab administration and at 12 months from the last cycle of trastuzumab | — |
Countries
Italy
Contacts
Public ContactU.O. CARDIOLOGIA Ia UNIVERSITARIA
U.O. CARDIOLOGIA Ia UNIVERSIATARIA
Outcome results
None listed