patients experiencing mild cardiotoxicity during treatment with anthracycline and/or trastuzumab for operable breast cancer
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: CARVEDILOL
CAS Number: 72956-09-3
Current Sponsor code: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6.25-
P
Sponsors
FONDAZIONE DEL PIEMONTE PER L'ONCOLOGIA IRCC DI CANDIOLO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women older than 18 years; Women with histological diagnosis of invasive breast cancer completely removed by surgery (any T, any N, M0); Women eligible for adjuvant and/or neoadjuvant treatment with anthracyclines and/or trastuzumab; Patients with HER-2 positive tumors assessed by immunohistochemistry and/or Fluorescent in Situ Hybridization (FISH); Adequate hematopietic, hepatic and renal function; Normal cardiac function with LVEF ³ 55% at the baseline; Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 175 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: Recurrent or metastatic disease; HER2 negative tumors; Concomitant cardiologic disease which would place the patient at unusual risk; LVEF < 55% at the baseline; Concurrent conditions that contraindicate cardiologic drugs used in this study; Patients with hypertension or other disease already treated with beta-blockers and/or ACE -inhibitors; Concomitant severe diseases which would place the patient at unusual risk; Patients treated with systemic investigational drugs within the past 4 weeks; Pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the therapeutic activity of early treatment with beta-blockers and ACE-inhibitors in patients experiencing mild cardiotoxicity during treatment with anthracycline and/or trastuzumab for operable breast cancer;Primary end point(s): To assess the therapeutic activity of early treatment with beta-blockers and ACE-inhibitors in patients experiencing mild cardiotoxicity during treatment with anthracycline and/or trastuzumab for operable breast cancer.;Timepoint(s) of evaluation of this end point: 60 months;Secondary Objective: To assess the predictive role of cardiovascular risk factors on the development of Left Ventricular Ejection Fraction (LVEF) dysfunctions during the adjuvant and/or neoadjuvant treatment with anthracyclines and/or trastuzumab To study the correlation between the pre-treatment value of BNP (Brain Natriuretic Peptide)or NT-proBNP (N-Terminal pro b-type Natriuretic Peptide) and Troponin I and the following modifications in relation to the outcomes of interest To study the correlation between ultrasonographic morpho-functional parameters and the outcomes of interest | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the predictive role of cardiovascular risk factors on the development of Left Ventricular Ejection Fraction (LVEF) dysfunctions during the adjuvant and/or neoadjuvant treatment with anthracyclines and/or trastuzumab To study the correlation between the pre-treatment value of BNP (Brain Natriuretic Peptide)or NT-proBNP (N-Terminal pro b-type Natriuretic Peptide) and Troponin I and the following modifications in relation to the outcomes of interest To study the correlation between ultrasonographic morpho-functional parameters and the outcomes of interest;Timepoint(s) of evaluation of this end point: 60 months | — |
Countries
Italy
Contacts
Public ContactUfficio Studi Clinici
Fondazione del Piemonte per l'Oncologia
Outcome results
None listed