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    Summary
    EudraCT Number:2017-004652-35
    Sponsor's Protocol Code Number:GIM22-ERICA
    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:2020-11-04
    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 number2017-004652-35
    A.3Full title of the trial
    Second line ERIbulin followed by CApecitabine or the reverse sequence in HER2-negative Metastatic Breast Cancer (MBC) patients: a randomized phase II study – ERICA trial
    ERIbulina in seconda linea seguita da CApecitabina o sequenza inversa in pazienti con carcinoma mammario metastatico (MBC) HER2-negativo: uno studio randomizzato di fase II – Studio ERICA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Second line ERIbulin followed by CApecitabine or the reverse sequence in HER2-negative Metastatic Breast Cancer (MBC) patients: a randomized phase II study – ERICA trial
    ERIbulina in seconda linea seguita da CApecitabina o sequenza inversa in pazienti con carcinoma mammario metastatico (MBC) HER2-negativo: uno studio randomizzato di fase II – Studio ERICA
    A.3.2Name or abbreviated title of the trial where available
    Second line ERIbulin followed by CApecitabine or the reverse sequence in HER2-negative Metastatic Br
    ERIbulina in seconda linea seguita da CApecitabina o sequenza inversa in pazienti con carcinoma mamm
    A.4.1Sponsor's protocol code numberGIM22-ERICA
    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 SponsorCONSORZIO ONCOTECH
    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 supportEISAI S.r.l.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Technology
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressVia San Leonardo - Traversa Migliaro
    B.5.3.2Town/ citySalerno
    B.5.3.3Post code84131
    B.5.3.4CountryItaly
    B.5.4Telephone number089301545
    B.5.5Fax number0897724155
    B.5.6E-mailhelpdesk.gim22@oncotech.org
    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 HALAVEN - 0.44MG/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO(VETRO) 2ML 6 FLACONCINI
    D.2.1.1.2Name of the Marketing Authorisation holderEISAI 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.3.1Product nameHALAVEN
    D.3.2Product code [Eribulina]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNERIBULINA
    D.3.9.2Current sponsor codeERIBULINA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number123
    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.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.2.1.1.1Trade name XELODA - 500 MG 120 COMPRESSE FILMRIVESTITE IN BLISTER USO ORALE
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    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.3.1Product nameXeloda
    D.3.2Product code [Capecitabina]
    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 INNCAPECITABINA
    D.3.9.2Current sponsor codeCAPECITABINA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1250
    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
    HER2-negative Metastatic Breast Cancer
    Carcinoma mammario metastatico HER2-negativo
    E.1.1.1Medical condition in easily understood language
    Metastatic Breast Tumour
    Tumore al seno metastatico
    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 PT
    E.1.2Classification code 10073100
    E.1.2Term Metaplastic breast carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    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
    Verify:
    - What is the correct placement of Eribulin in the context of a long term treatment strategy
    - if an early use of Eribulin is the best approach for MBC pts treatment
    - if early use of Eribulin can impact on subsequent treatment outcomes
    Verificare:
    - qual è la corretta collocazione dell’eribulina nel contesto di una strategia di trattamento a lungo termine.
    - se un utilizzo iniziale dell’eribulina è il migliore approccio nel trattamento dei pazienti con MBC
    - se l’uso precoce dell’eribulina può avere un impatto sui successivi esiti di trattamento.
    E.2.2Secondary objectives of the trial
    - Survival assessment
    - Quality of life
    - Exploratory evaluations (liquid biopsies and ctDNA evaluation could help to monitor the course of the disease and to identify novel biomarkers of drug resistance)
    - Analisi di sopravvivenza
    - Qualità di vita
    - Analisi esploratorie (le biopsie liquide e la valutazione del ctDNA potrebbero aiutare a monitorare il corso della malattia e ad identificare nuovi biomarker di resistenza ai farmaci)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent (both for clinical and blood biomarker study);
    2. Histological diagnosis of HER2 negative MBC;
    3. Females >= 18;
    4. Measurable disease (according RECIST criteria version 1.1)
    5. Prior Anthracyclines and Taxanes
    6. 1 prior cytotoxic regimen for advanced or MBC (not including adjuvant or neo-adjuvant therapy). Patients with no prior cytotoxic regimens for advanced or metastatic disease will only be allowed if they relapsed during or within 6 months of (neo-) adjuvant cytotoxic therapy that included anathracyclines and taxanes;
    7. Prior hormonotherapy and Cyclines inhibitors are allowed, so as indicated in the international guidelines for the management of hormone positive breast cancer (ER and/or PR positive);
    8. ECOG Performance Status <= 2
    9. Absence of angina or heart failure or infarction within 12 months from inclusion;
    10. Adequate bone marrow and organ function as follows (haemoglobin >= 9.0 g/dl; absolute neutrophil count >= 1.5x103/mm3; plateled count >= 100x103/mm3; bilirubin levels <= 1.5 times Upper Limits of Normal - biliary stenting is allowed to resolve obstruction – Serum Transaminase level <= 2.5 times ULN; serum creatinine <= 1.5 times ULN
    11. Life expectancy of at least 12 weeks
    12. If women of childbearing potential age: effective contraceptive measures must be used during the study treatment period and up to 3 months after the last dose of study drug.
    1. Consenso informato scritto (sia per lo studio principale che per lo studio sui biomarker);
    2. Diagnosi istologica di MBC HER2-negativo;
    3. Donne >= 18 anni;
    4. Malattia misurabile (in accordo ai criteri RECIST v. 1.1);
    5. Precedente trattamento con antracicline e taxani;
    6. 1 precedente regime citotossico per carcinoma della mammella avanzato o metastatico (non è inclusa la terapia adiuvante o neoadiuvante). Nota: Pazienti senza alcun precedente regime citotossico per la malattia avanzata o metastatica saranno ammessi solo se recidivati durante o entro 6 mesi dalla terapia citotossica (neo-) adiuvante che includeva antracicline e taxani;
    7. Sono consentiti precedenti linee di ormonoterapia e trattamenti con inibitori delle cicline, come indicato nelle linee guida internazionali sulla gestione del carcinoma mammario positivo ai recettori ormonali (ER e/o PR positivo);
    8. ECOG Performance Status <= 2;
    9. Assenza di angina o insufficienza cardiaca o infarto entro 12 mesi dall’arruolamento;
    10. Adeguata funzione d’organo e di midollo osseo come segue (emoglobina >= 9.0 g/dl; conta assoluta dei neutrofili >= 1.5x103/mm3; conta piastrinica >= 100x103/mm3; livelli di birilubina <= 1.5 volte il limite superiore della norma (ULN) – è consentito lo stenting biliare per risolvere ostruzioni – livello di Transaminasi sieriche <= 2.5 volte ULN; creatinina sierica <= 1.5 times ULN;
    11. Aspettativa di vita di almeno 12 settimane;
    12. Se donne in età fertile: devono essere utilizzati metodi contraccettivi efficaci durante il periodo di trattamento e fino a 3 mesi dopo l’ultima dose di farmaco in studio.
    E.4Principal exclusion criteria
    1. Unability to give informed consent;
    2. Absence of measurable disease;
    3. Concurrent active malignancies (except of in situ carcinoma of the cervix and inactive non-melanoma skin cancer);
    4. Current active infection;
    5. Serious pre-existing medical conditions or serious concomitant diseases;
    6. Systemic disorders that would compromise the safety of the patient or her ability to complete the study, at the discretion of the investigator (for example, unstable angina pectoris, or a clinically significant history of cardiac disease or uncontrolled diabetes mellitus);
    7. Known immunodeficiency virus infection;
    8. Pregnant or breastfeeding women;
    9. Unable to undergo medical test for geographical, social or psychological reason
    10. Active or symptomatic brain metastases.
    1. Incapacità di dare il consenso informato;
    2. Assenza di malattia misurabile;
    3. Tumori attivi concomitanti (ad eccezione del carcinoma in situ della cervice e del tumore cutaneo non-melanoma inattivo);
    4. Infezione attiva corrente;
    5. Serie condizioni mediche pre-esistenti o serie malattie concomitanti;
    6. Disturbi sistemici che comprometterebbero la sicurezza del paziente o la sua capacità di completare lo studio, a discrezione dello sperimentatore (per esempio, angina pectoris instabile, o una storia clinica significativa di patologia cardiaca o diabete mellito incontrollato);
    7. Nota infezione da virus dell’immunodeficienza;
    8. Donne in gravidanza o in allattamento;
    9. Incapacità di sottoporsi a test medici per ragioni geografiche, sociali o psicologiche;
    10. Metastasi cerebrali sintomatiche o attive.
    E.5 End points
    E.5.1Primary end point(s)
    Total Progression-Free Survival (PFS-T)
    Sopravvivenza totale libera da progressione (PFS-T)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Between randomization and the first event among the following:
    • the date of progression after the second treatment on study – whichever the second treatment will be according to intention-to-treat (eventual departures from treatments planned in the protocol will be described)
    • the date of death if death occurs before second progression
    Tra la randomizzazione e il primo tra i seguenti:
    • la data di progressione dopo il secondo trattamento di studio – qualunque sia il secondo trattamento in accordo all’intention-to-treat (eventuali deviazioni dai trattamenti pianificate nel protocollo saranno descritte)
    • la data del decesso se il decesso si verifica prima della seconda progressione.
    E.5.2Secondary end point(s)
    - Overall Survival from the date of randomization - Health-related Quality of Life (QoL)
    - Disease Control Rate (DCR: proportion of patients obtaining complete response or partial response or stable disease >= 6 months): in second line; In third line; In second and/or third line
    - Post Progression Survival (PPS)
    - Sopravvivenza globale (OS) dalla data di randomizzazione
    - Qualità di vità salute-correlata (QoL)
    - Tasso di controllo della malattia (DCR: percentuale di pazienti che hanno ottenuto una risposta completa o risposta parziale o con malattia stabile per un periodo >= 6 mesi): in seconda linea; In terza linea; In seconda e/o terza linea
    - Sopravvivenza post progressione (PPS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - At disease progression/death
    - At screening /at tumor assessment / at progression
    - A progressione/decesso
    - Allo Screening / alla valutazione /alla progressione
    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
    Stesso schema terapeutico con i due farmaci a sequenza invertita
    The same treatment with two IMPs in reverse sequence
    E.8.2.4Number of treatment arms in the trial2
    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 concerned39
    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 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
    LVLS
    LVLS
    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 months44
    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 months44
    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: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    According to current clinical practice of each site
    Come da normale pratica clinica di ogni centro clinico
    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 Decision2018-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-08-30
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