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    Summary
    EudraCT Number:2014-005508-62
    Sponsor's Protocol Code Number:TRINACRIA
    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:2021-06-08
    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 number2014-005508-62
    A.3Full title of the trial
    A phase II, randomized, non-comparative, pre-surgical study of atorvastatin or observation in Ki-67 positive, TAZ-expressing early breast cancer patients
    Atorvastatina vs osservazione in pazienti con carcinoma mammario in fase iniziale con elevato Ki-67 e positivit¿ per TAZ:
    studio pre-chirurgico di fase II randomizzato, non comparativo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II, randomized, non-comparative, pre-surgical study of atorvastatin or observation in early breast cancer patients
    Atorvastatina vs osservazione in pazienti con carcinoma mammario in fase iniziale con caratteristiche biologiche definite:
    studio pre-chirurgico di fase II randomizzato, non comparativo
    A.3.2Name or abbreviated title of the trial where available
    TRINACRIA TRIAL
    TRINACRIA TRIAL
    A.4.1Sponsor's protocol code numberTRINACRIA
    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 SponsorISTITUTI FISIOTERAPICI OSPITALIERI
    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 supportIstituto Regina Elena
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO REGINA ELENA
    B.5.2Functional name of contact pointRESPONSABILE SCIENTIFICO
    B.5.3 Address:
    B.5.3.1Street AddressVIA ELIO CHIANESI 53
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00144
    B.5.3.4CountryItaly
    B.5.4Telephone number06-52662724
    B.5.5Fax number06-52665075
    B.5.6E-mailmaugeri@ifo.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.2.1.1.1Trade name ATORVASTATINA PFIZER - 80 MG COMPRESSE RIVESTITE CON FILM 98 COMPRESSE IN BLISTER PA/AL/PVC-CARTA/PET/AL
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA S.R.L.
    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 Film-coated 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 INNATORVASTATINA
    D.3.9.1CAS number 134523-00-5
    D.3.9.2Current sponsor code120908
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Early breast cancer
    Carcinoma mammario in fase iniziale
    E.1.1.1Medical condition in easily understood language
    Early breast cancer
    Tumore della mammella operabile
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10006175
    E.1.2Term Breast adenocarcinoma stage I
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10006176
    E.1.2Term Breast adenocarcinoma stage II
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Ki-67 reduction
    Riduzione del ki-67
    E.2.2Secondary objectives of the trial
    the rate of decreased TAZ expression and its correlation with Ki-67 reduction, the predictive value of HMG-CoA reductase expression, and downgrading
    Valutare il tasso di riduzione dell'espressione di TAZ e la sua correlazione con la riduzione del Ki67
    - Valutare il valore predittivo dell¿espressione dell'HMG-CoA reduttasi.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signed written informed consent
    Female aged >18 years and <75 years at the time of the enrolment
    Histologically confirmed BC independently on the intrinsic subtype
    Stage I-IIa BC patients candidate for elective surgery
    BC expressing Ki-67 = 15% and TAZ > 10% in diagnostic core biopsies
    Adequate baseline organ function
    Negative pregnancy test
    Patients of childbearing potential must agree to use a double effective method of contraception throughout the study and for 3 months after the last dose of assigned treatment.
    - Diagnosi istologica di carcinoma mammario (qualsiasi istologia) stadio I-IIa
    - Elevato Ki67 (=15%) e iperespressione di TAZ (=10%) alla biopsia diagnostica
    - Indicazione ad effettuare intervento chirurgico in elezione
    - Età > 18 anni
    - Consenso informato scritto
    - Pazienti con potenziale riproduttivo che acconsentano ad utilizzare una doppia barriera contraccettiva per tutta la durata del trattamento e per i 3 mesi successivi all’ultima somministrazione del farmaco.
    E.4Principal exclusion criteria
    Previous systemic therapy including chemotherapy, hormone therapy and targeted agents
    Administration of an investigational drug prior to enrolment
    History of another malignancy. Except for a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma.
    Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome and asymptomatic gallstones)
    Serious cardiac illness or medical conditions including but not confined to: history of documented congestive heart failure (CHF) or systolic dysfunction (LVEF <50%); high-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately controlled); angina pectoris requiring antianginal medication; clinically significant valvular heart disease; evidence of transmural infarction on ECG; poorly controlled hypertension (e.g. systolic >180mm Hg or diastolic >100mm Hg)
    Have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection or any psychiatric condition prohibiting understanding or rendering of informed consent)
    Current or recent therapy with statins for hypercholesterolemia or other lipid-lowering drugs
    Current or recent therapy with glucose-lowering drugs for diabetes
    History of hypothyroidism
    personal or family history of hereditary muscular disorders
    Previous myotoxicity due to statins and/or fibrates
    - Precedente chemioterapia
    - Performance status (valutato secondo i criteri dell’Eastern Cooperative Oncology Group) = 2
    - Storia di neoplasie nei precedenti 10 anni (eccetto tumori cutanei, non-melanoma, o carcinoma cervicale in situ escisso).
    - Attuale terapia con inibitori del CYP3A4
    - Attuale o recente terapia con gemfibrozil o altri fibrati
    - Insufficienza renale o epatica
    - Ipercolesterolemia in trattamento farmacologico
    - Insufficienza cardiaca congestizia o angina pectoris anche se controllate
    - Precedente storia di infarto miocardico, ipertensione non controllata, o aritmia
    - Storia di disordini neurologici o psichiatrici inclusi demenza ed epilessia
    - Infezione in atto
    - Altre malattie gravi
    - Trattamento con altri farmaci sperimentali
    - Inaccessibilità geografica per il trattamento e follow up
    - Incapacità a comprendere e/o firmare consenso informato scritto
    - Donne in gravidanza o in allattamento
    - Attuale o pregresso ipotiroidismo
    - Anamnesi personale o familiare positiva per disturbi muscolari ereditari
    - Anamnesi positiva per pregressa tossicità muscolare in seguito ad assunzione di statine e/o fibrati
    E.5 End points
    E.5.1Primary end point(s)
    the rate of Ki-67 reduction below the 15%
    tasso di riduzione del Ki67 al di sotto del 15%
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 weeks
    3 settimane
    E.5.2Secondary end point(s)
    the rate of decreased TAZ expression; KI67 and TAZ correlation; predictive value of HMG-CoA reductase expression
    il tasso di riduzione dell'espressione di TAZ ; correlazione tra espressione di Ki67 e TAZ; valore predittivo dell¿espressione dell'HMG-CoA reduttasi
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 weeks; 3 weeks; 3 weeks
    3 settimane; 3 settimane; 3 settimane
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Osservazione
    Observation
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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
    Last surgery last patient
    Ultimo intervento per l'ultima paziente
    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 months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state78
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    F.4.2.2In the whole clinical trial 78
    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)
    Standard of care
    Normale pratica clinica
    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 Decision2015-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-04
    P. End of Trial
    P.End of Trial StatusOngoing
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