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    Summary
    EudraCT Number:2011-002207-15
    Sponsor's Protocol Code Number:Cardiorete
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-03-08
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-002207-15
    A.3Full title of the trial
    A prospective study with beta-blockers and ACE-inhibitors in patients operable breast cancer experiencing mild cardiac toxicity during treatment with anthracycline and/or trastuzumab
    Studio prospettico sull'utilizzo della terapia cardiologica con beta-bloccanti ed ace-inibitori in pazienti con tumore mammario operabile e cardiotossicita' lieve da trattamento con antracicline e/o trastuzumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective study with beta-blockers and ACE-inhibitors in patients operable breast cancer experiencing mild cardiac toxicity during treatment with anthracycline and/or trastuzumab
    Studio prospettico sull'utilizzo della terapia cardiologica con beta-bloccanti ed ace-inibitori in pazienti con tumore mammario operabile e cardiotossicita' lieve da trattamento con antracicline e/o trastuzumab
    A.3.2Name or abbreviated title of the trial where available
    Cardiorete
    Cardiorete
    A.4.1Sponsor's protocol code numberCardiorete
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFONDAZIONE DEL PIEMONTE PER L'ONCOLOGIA IRCC DI CANDIOLO
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRete Oncologica Piemontese
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione del Piemonte per l'Oncologia
    B.5.2Functional name of contact pointUfficio Studi Clinici
    B.5.3 Address:
    B.5.3.1Street Addressstr. Provinciale 142
    B.5.3.2Town/ cityCandiolo
    B.5.3.3Post code10060
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 011 9933278
    B.5.5Fax number+39 011 9933299
    B.5.6E-mailluisa.gioeni@ircc.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCARVEDILOL
    D.3.9.1CAS number 72956-09-3
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB06153MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNENALAPRIL
    D.3.9.1CAS number 75847-73-3
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB06514MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients experiencing mild cardiotoxicity during treatment with anthracycline and/or trastuzumab for operable breast cancer
    pazienti con cardiotossicità lieve insorta durante trattamento adiuvante e/o neoadiuvante con antracicline e/o trastuzumab
    E.1.1.1Medical condition in easily understood language
    patients experiencing mild cardiotoxicity during treatment with anthracycline and/or trastuzumab for operable breast cancer
    pazienti con cardiotossicità lieve insorta durante trattamento adiuvante e/o neoadiuvante con antracicline e/o trastuzumab
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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
    Valutare l’attività terapeutica del trattamento precoce con beta-bloccanti ed ACE-inibitori in pazienti con cardiotossicità lieve insorta durante trattamento adiuvante e/o neoadiuvante con antracicline e/o trastuzumab
    E.2.2Secondary objectives of the trial
    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
    Valutare il ruolo predittivo di noti fattori di rischio cardiologico sullo sviluppo di disfunzioni della FEVS in corso di trattamento adiuvante e/o neoadiuvante con antracicline e/o trastuzumab; Studiare la correlazione tra valori pre-trattamento di BNP (Brain Natriuretic Peptide) o NT-proBNP (N-terminal pro b-type natriuretic peptide) e troponina I e successive modificazioni in relazione agli outcomes di interesse; Studiare la correlazione tra parametri ultrasonografici morfofunzionali di base ed outcomes di interesse.
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    Donne di età ≥ 18 anni Diagnosi istologica di tumore della mammella operabile (qualunque T, qualunque N, M0); Iperespressione del gene HER2 valutata mediante test immunoistochimico (DAKO HercepTest) o amplificazione del gene HER 2 valutata con esame FISH (Fluorescent in Situ Hybridization). In caso di neoplasie caratterizzate da iperespressione di HER2 dubbia sarà richiesta conferma con esame FISH; Indicazione a trattamento adiuvante e/o neoadiuvante chemioterapico contenente antracicline e/o trastuzumab; non è necessario che siano somministrate antracicline; Adeguate funzioni emopoietica, epatica e renale in accordo con i seguenti parametri di laboratorio: emoglobina &gt; 10 g / dl e non emotrasfusioni entro le precedenti 2 settimane, ANC (conta neutrofila assoluta) &gt; 1.5 109/l, piastrine &gt; 100 x 109/l, non evidenze di sindrome mielodisplastica o compromessa riserva midollare, creatinina &lt; 1.5 volte i limiti normali (UNL) o clearance creatininica &gt; 60 ml / min, bilirubina totale &lt; 1 x UNL, AST (SGOT) e/o ALT (SGPT) &lt; 2.5 x UNL,fosfatasi alcalina &lt; 5x UNL; Normale funzionalità cardiaca, con FEVS misurata ecograficamente ≥ 55% alla baseline prima della chemioterapia; Firma del consenso informato; È ammessa una terapia antiipertensiva, purchè non contenga ACE-inibitori e/o beta-bloccanti, che la paziente proseguirà come da prescrizione; Per donne in età fertile test di gravidanza ed adeguata contraccezione durante il periodo di trattamento.
    E.4Principal 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.
    Tumore della mammella stadio IV; Tumore HER2-negativo; Pazienti con comorbidità cardiologica attiva: cardiopatia Ischemica (pregresso infarto miocardico, esiti di angioplastica con stent o di bypass aortocoronarico), cardiopatie valvolari clinicamente rilevanti (di entità moderata o moderata severa, esiti di sostituzioni valvolari o di protesi vascolari aortiche), cardiomiopatie, fibrillazione atriale permanente, pregresso impianto di Pacemaker (PM) o defibrillatore impiantabile (ICD), Riscontro ecocardiografico alla baseline prima della chemioterapia di FEVS &lt; 55%; Pazienti con ipertensione arteriosa o altra condizione morbosa già in trattamento con ACE-inibitori e/o beta-bloccanti; Pazienti che abbiano controindicazioni note all’utilizzo di enalapril quali ipersensibilità a enalapril o a uno qualsiasi degli eccipienti o ad altri ACE-inibitori, anamnesi di angioedema associato a precedente terapia con ACE-inibitori, angioedema ereditario o idiopatico; Pazienti che abbiano controindicazioni note all’utilizzo di carvedilolo quali insufficienza cardiaca (NYHA classe IV) (vedi appendice II) che richiede trattamento inotropo per via endovenosa; malattia polmonare cronica ostruttiva con ostruzione bronchiale; disfunzione epatica clinicamente significativa; asma bronchiale; blocco atrio ventricolare grado II o III; bradicardia sinusale (&lt;50 battiti per minuto); sindrome del nodo del seno (incluso blocco seno-atriale); shock cardiogeno; ipotensione severa (pressione sistolica sotto 85 mmHg); angina di Prinzmetal; feocromocitoma non trattato; ipersensibilità a carvedilolo o ad uno degli eccipienti; acidosi metabolica; disturbi circolatori severi delle arterie periferiche; trattamento concomitante con verapamil o diltiazem per via endovenosa; Pazienti inserite in studi clinici prospettici di terapia adiuvante con farmaci anti-HER2 ove emerge una specifica incompatibilità; Pazienti con patologie gravi non controllate che compromettano la capacità di ricevere il trattamento; Pazienti che abbiano utilizzato qualunque farmaco in fase sperimentale durante le 4 settimane precedenti l’arruolamento; Gravidanza o allattamento in atto; Donne in età fertile che non utilizzino un metodo anticoncezionale adeguato.
    E.5 End points
    E.5.1Primary 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.
    Valutare l’attività terapeutica del trattamento precoce con beta-bloccanti ed ACE-inibitori in pazienti con cardiotossicità lieve insorta durante trattamento adiuvante e/o neoadiuvante con antracicline e/o trastuzumab.
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 months
    60 mesi
    E.5.2Secondary 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
    Valutare il ruolo predittivo di noti fattori di rischio cardiologico sullo sviluppo di disfunzioni della FEVS in corso di trattamento adiuvante e/o neoadiuvante con antracicline e/o trastuzumab; Studiare la correlazione tra valori pre-trattamento di BNP (Brain Natriuretic Peptide) o NT-proBNP (N-terminal pro b-type natriuretic peptide) e troponina I e successive modificazioni in relazione agli outcomes di interesse; Studiare la correlazione tra parametri ultrasonografici morfofunzionali di base ed outcomes di interesse.
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 months
    60 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of study expected at the end of FU period of all 60 patients who have experienced mild cardiotoxicity during clinical study participation.
    Conclusione prevista al termine del periodo di FU di tutte le 60 pazienti che hanno sviluppato cardiotossicità lieve durante la partecipazione al protocollo di studio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months60
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 175
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    When subject has ended her participation in the trial, patient will receved treatment and care in accordance with therapeutic standards
    Al termine della partecipazione allo studio la paziente verrà trattata e assistita secondo lo standard terapeutico.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-17
    P. End of Trial
    P.End of Trial StatusOngoing
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