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    Summary
    EudraCT Number:2014-004194-16
    Sponsor's Protocol Code Number:IRFMN-BRC-6591
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-20
    Trial results View 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 number2014-004194-16
    A.3Full title of the trial
    A multicenter, single-arm, phase II study to evaluate the activity of
    pre-operative zoledronate in triple negative breast cancer patients, according to p53 level
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study aimed to assess in patients with triple-negative operable breast cancer the activity of the drug zoledronate administered before surgery, according to the the tumor aggressiveness (determined by the level of expression of the p53 protein)
    Studio clinico che valuta l’attivita del farmaco zoledronato somministrato prima dell’intervento di asportazione del tumore in pazienti con tumore del seno triplo negativo operabile, in base alla aggressività del tumore (determinata dal livello di espressione della proteina p53)
    A.3.2Name or abbreviated title of the trial where available
    TRIPLE NEGATIVE
    TRIPLE NEGATIVE
    A.4.1Sponsor's protocol code numberIRFMN-BRC-6591
    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 SponsorIRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
    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 support Associazione Italiana per la Ricerca sul Cancro
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS-Istituto di Ricerche Farmacologiche Mario Negri
    B.5.2Functional name of contact pointLaboratorio Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Giuseppe La Masa 19
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.4Telephone number0039 02 39014695
    B.5.5Fax number0039 02 33200231
    B.5.6E-mailirene.floriani@marionegri.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 ZOMETA - 4 MG POLVERE E SOLVENTE PER SOLUZIONE PER INFUSIONE ENDOVENOSA 1 FLACONCINO + 1 FIALA SOLVENTE 5 ML
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS EUROPHARM LTD
    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 Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Newly diagnosed, untreated, operable triple negative breast cancer
    Tumore mammario triplo negativo appena diagnosticato, operabile e non trattato
    E.1.1.1Medical condition in easily understood language
    Newly diagnosed, untreated, operable triple negative breast cancer
    Tumore del seno triplo negativo appena diagnosticato, operabile e che non ha ricevuto nessuna terapia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study is primarily aimed at assessing the anti-tumor activity of pre-operative zoledronate measured through its effect on the Ki67 proliferative surrogate biomarker, in patients with triple negative breast cancer selected according to the p53 expression (high vs low p53 expression).
    L’obiettivo primario dello studio è valutare l’attività antitumorale del trattamento pre-operatorio con zoledronato nel tumore della mammella triplo negativo attraverso l’analisi della espressione del biomarker della proliferazione cellulare Ki67 e in funzione dei livelli di espressione di p53.
    E.2.2Secondary objectives of the trial
    To investigate the effect of zoledronate on critical genes/proteins related to p53 and mevalonate pathways, p53/PIN1 and YAP/TAZ, analyzed at the time of diagnosis (core biopsy) and at definitive surgery (breast cancer resection).

    To study the safety profile of zoledronate, evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) scale, version 4.0 and by the occurrence of serious adverse reactions.
    Analisi della espressione di geni e proteine correlate a p53 ed al pathway del mevalonato, al momento della diagnosi (biopsia) e dopo il trattamento con zoledronato, al momento della asportazione definitiva della massa tumorale, condotta come segue:
    • valutazione delle proteine p53/PIN1 e YAP/TAZ mediante immunoistochimica (IHC)
    • analisi molecolare dell’espressione dei geni p53/PIN-1 e YAP/TAZ mediante RT-PCR

    Valutazione del profilo di sicurezza del trattamento, determinato in accordo con i National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) versione 4.0 ed attraverso l’occorrenza degli eventi avversi.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with newly diagnosed, untreated, operable triple negative breast cancer (TNBC), intended to definitive breast surgery and suitable for pre-operative therapy with zol.
    Patients must meet all the following criteria for study entry:
    ­- Histologically confirmed diagnosis of non-metastatic operable TNBC subjected to diagnostic core biopsy
    ­- TNBC defined as HER2/ER/PgR negative receptors
    ­- Age ≥ 18 years old
    ­- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1
    ­­- Ki67 and p53 expression determined by IHC
    ­- Availability of paraffin-embedded tumor block (FFPE) taken at diagnostic biopsy for IHC and RT-PCR molecular determinations
    ­- Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to start of trial. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months (female patients) and 6 months (male patients) after discontinuation of treatment.
    ­- Written informed consent signed prior to enrolment according to ICH/GCP.
    Pazienti che hanno appena ricevuto una diagnosi di tumore mammario triplo negativo, operabile e non ancora trattato, destinati all’intervento di asportazione chirurgica definitiva del tumore e idonei al trattamento pre-operatorio con lo zoledronato.
    Per l’inclusione nello studio, i pazienti devono possedere tutti i seguenti requisiti:
    ­-Diagnosi istologica di tumore mammario triplo negativo, operabile e non- metastatico
    ­- Età ≥ 18 anni
    ­- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1
    ­­- Espressione di Ki67 e p53 determinata attraverso IHC
    ­- Disponibilità di un campione di tumore fissato in paraffina (FFPE) proveniente dalla biopsia utilizzata per la diagnosi, per le analisi molecolari ed immunoistochimiche
    ­- Le pazienti di sesso femminile in età fertile, devono avere test di gravidanza negativo entro 7 giorni dall’inizio del trial. I pazienti di entrambi i sessi devono acconsentire all’uso di idonei metodi contraccettivi durante il periodo di trattamento e nei 3 mesi (pazienti donne) e 6 mesi (pazienti uomini) successivi alla fine dello stesso.
    - In accordo alle norme dettate nelle ICH/GCP consenso informato scritto prima del reclutamento.
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from study entry:
    ­- Presence of metastatic disease
    ­- Clinical indication of debulking neo-adjuvant treatment
    ­- Previous investigational treatment for any condition within four weeks prior to study registration
    -Treatment with bisphosphonates, denosumab or other drug that, in the Investigator’s judgment, affects bone metabolism
    -Treatment with statins or other drugs that, in the Investigator’s judgment, potentially affect the mevalonate pathway
    ­- Any previous treatment for the currently diagnosed breast cancer, including radiation therapy, chemotherapy, biotherapy and/or hormonal therapy
    ­- Inadequate bone marrow, hepatic or renal function including the following:
    • Hb< 9.0 g/dL, absolute neutrophil count < 1.5 x 109/L, platelets <100 x 109/L
    • Total bilirubin > 1.5 x ULN, excluding cases where elevated bilirubin can be attributed to Gilberts Syndrome
    • AST (SGOT), ALT (SGPT) > 2.5 x ULN
    • Creatinine > 1.2 x ULN, calcium < 8.6 mg/dL
    ­- Co-existing active infection or concurrent illness that, at the judgment of the investigator, contra-indicate the inclusion of the patient in the study
    ­- Co-existing dental diseases that form a contraindication to the use of zol
    ­- Any medical or other condition that in the Investigator’s opinion renders the patient unsuitable for this study due to unacceptable risk
    ­- Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study assessment and procedures
    ­- Known hypersensitivity to any excipients of zoledronate
    ­- Anticipation of need for major surgical procedure during the course of the trial
    ­- Pregnant or breast feeding women.
    I pazienti che possiedono i seguenti requisiti non potranno prender parte allo studio:
    ­- Presenza di tumore metastatico
    ­- Indicazione clinica di trattamento neo-adiuvante
    ­- Trattamenti sperimentali per altre patologie nelle 4 settimane antecedenti alla registrazione allo studio
    - Trattamento con bifosfonati, denosumab o, a giudizio del medico sperimentatore, farmaci che agiscono sull’osso
    ­- Trattamento con statine o con farmaci che, a giudizio del medico sperimentatore, hanno potenzialmente un impatto sul pathway del mevalonato
    ­- Qualsiasi trattamento precedente, incluse radioterapia, chemioterapia, terapia con farmaci biologici e/o terapie ormonali correntemente utilizzate in caso di diagnosi di tumore al seno
    ­- Alterazioni della funzionalità del midollo osseo, epatica e renale, di seguito elencate:
    • Hb< 9.0 g/dL, conta totale dei neutrofili< 1.5 x 109/L, piastrine <100 x 109/L
    • Bilirubina totale > 1.5 x ULN, ad eccezione dei casi in cui gli elevate valori di bilirubina siano attribuibili alla Sindrome di Gilberts
    • AST (SGOT), ALT (SGPT) > 2.5 x ULN
    • Creatinina > 1.2 x ULN, calcio < 8.6mg7dL
    ­- Infezioni attive concomitanti o gravi patologie concorrenti che possano costituire una controindicazione all’inclusione del paziente nello studio
    ­- Qualsiasi condizione medica o non, che secondo l’opinione del medico sperimentatore renda il paziente non adatto a questo studio per via di un rischio troppo alto
    ­- Disordini psichiatrici o stato mentale alterato che precludano la comprensione del consenso informato e/o il completamento delle valutazioni e delle procedure necessarie per lo studio
    ­- Nota ipersensibilità ad uno degli eccipienti dell’Acido Zoledronico
    ­- Necessita di ricevere cure odontoiatriche
    ­- Stato di gravidanza o allattamento.
    E.5 End points
    E.5.1Primary end point(s)
    The study is primarily aimed at assessing the anti-tumor activity of pre-operative zoledronate (zol), measured through its effect on the Ki67 proliferative surrogate biomarker, in patients with TNBC selected according to the p53 expression (high vs low p53 expression). Primary endpoint of the study is the proportion of responder patients, defined as those with at least 30% reduction in Ki67 at surgery with respect to core-biopsy analysis. Prior to enrolment, the FFPE diagnostic core biopsy specimens will be analyzed by the study pathologist to determine the presence of invasive TNBC and the Ki67/p53 values. The ki67/p53 evaluation will be then repeated after treatment at the time of definitive surgery.
    L’obiettivo primario dello studio è valutare l’attività antitumorale del trattamento pre-operatorio con lo zoledronato attraverso l’analisi della espressione del biomarker della proliferazione cellulare Ki67, nel tumore della mammella triplo negativo, in funzione dei livelli di espressione di p53. L'ipotesi da testare è che la percentuale dei responder al trattamento con zoledronato nel gruppo di pazienti ad elevato livello di espressione di p53 sarà del 75% e nel gruppo con basso livello di espressione di p53 sarà del 20%. Prima dell’arruolamento, i campioni di tessuto tumorale fissati in paraffina (FFPE) provenienti della biopsia saranno analizzati dal patologo per determinare la presenza di TNBC invasivo ed i valori di Ki67/p53. La valutazione dell’espressione di Ki67/p53 sarà ripetuta dopo il trattamento, al momento dell’intervento chirurgico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint (proportion of responder patients, defined as those with at least 30% reduction in Ki67 at surgery with respect to core-biopsy analysis) will be evaluated after the definitive breast surgery planned seven days after study treatment (i.e. Zometa administration).
    L'endpoint primario, ovvero la percentuale di pazienti responder, definiti come la percenuale di pazienti in cui l’espressione di Ki67 risulta ridotta di almeno il 30% nel campione di tessuto tumorale prelevato alla chirurgia rispetto alla biopsia, sarà valutato dopo l'intervento chirurgico di rimozione del tumore previsto sette giorni dopo il trattamento in studio (somministrazione Zometa).
    E.5.2Secondary end point(s)
    To investigate the effect of zoledronate on critical genes/proteins related to p53 and mevalonate pathways, p53/PIN1 and YAP/TAZ, analyzed at the time of diagnosis (core biopsy) and at definitive surgery (breast cancer resection). After enrolment, the FFPE core biopsy will be tested for critical genes/proteins expression (by RT-PCR and IHC), including p53/PIN1 and YAP/TAZ. The same evaluations will be performed after treatment, at the time of definitive surgery. To study the safety profile of zoledronic acid, evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) scale, version 4.0 and by the occurrence of serious adverse reactions.
    Analisi della espressione di geni e proteine correlate a p53 ed al pathway del mevalonato, al momento della diagnosi (biopsia) e dopo il trattamento con Zometa, al momento della asportazione definitiva della massa tumorale, condotta come segue: • valutazione delle proteine p53/PIN1 e YAP/TAZ mediante IHC • analisi molecolare dell’espressione dei geni p53/PIN-1 e YAP/TAZ mediante RT-PCR. Valutazione del profilo di sicurezza del trattamento,determinato in accordo con i National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) versione 4.0 ed attraverso l’occorrenza degli eventi avversi
    E.5.2.1Timepoint(s) of evaluation of this end point
    The evaluation of critical genes/proteins expression (by RT-PCR and IHC), including p53/PIN1 and YAP/TAZ will be performed on the core biopsy and after treatment, at the time of definitive surgery, planned seven days after study treatment. Zometa safety profile will be evaluated through the duration of the study and post treatment at 30 and 60 days following definitive surgery.
    L’obiettivo secondario ovvero l'analisi della espressione di geni e proteine correlate a p53 ed al pathway del mevalonato, verrà valutato al momento della diagnosi (biopsia) e dopo il trattamento con zoledronato, al momento dell' intervento chirurgico di asportazione definitiva della massa tumorale, previsto sette giorni dopo la somministrazione di Zometa. Il profilo di sicurezza di Zometa verrà valutato durante il trattamento e nel periodo di follow-up a 30 e 60 giorni dopo l'intervento chirurgico.
    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 Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    A braccio singolo
    Single arm
    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.8.2.3.1Comparator description
    Single arm
    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 concerned2
    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
    Last visit of the last subject undegoing the trial.
    Ultima visita dell'ultimo soggetto registrato nello studio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 22
    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 Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Treatment and care of subjects who have ended the participation in the trial is not different from the expected normal treatment of that condition.
    Il trattamento dei pazianti che hanno terminato lo studio non sarà diverso da quello previsto dalla 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 Decision2014-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-08
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