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    The EU Clinical Trials Register currently displays   31566   clinical trials with a EudraCT protocol, of which   5087   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-003400-24
    Sponsor's Protocol Code Number:I3Y-MC-JPBZ
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-12-10
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-003400-24
    A.3Full title of the trial
    monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib plus Trastuzumab with or without Fulvestrant to Standard-of-Care Chemotherapy of Physician?s Choice plus Trastuzumab in Women with HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
    monarcHER: Estudio fase 2, aleatorizado, multicéntrico, abierto, de 3 grupos, para comparar la eficacia del tratamiento de combinación con abemaciclib y trastuzumab (con o sin fulvestrant) frente al estándar de tratamiento con la combinación de trastuzumab y la quimioterapia de referencia que determine el investigador, en mujeres con cáncer de mama HR+, HER2+ localmente avanzado o metastásico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Abemaciclib plus Trastuzumab with or without Fulvestrant in Participants with HR+, HER2+ Metastatic Breast Cancer.
    Estudio de Abemaciclib mas Trastuzumab con o sin Fulvestrat en pacientes con cancer de mama metastasico HR+, HER2+
    A.3.2Name or abbreviated title of the trial where available
    monarcHER
    A.4.1Sponsor's protocol code numberI3Y-MC-JPBZ
    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 SponsorLilly S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressAvda de la Industria 30
    B.5.3.2Town/ cityAlcobendas Madrid
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number3491663 53 27
    B.5.5Fax number34916633481
    B.5.6E-mailensayosclinicos@lilly.com
    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 No
    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 nameabemaciclib
    D.3.2Product code LY2835219
    D.3.4Pharmaceutical form Capsule
    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 INNabemaciclib
    D.3.9.3Other descriptive nameABEMACICLIB
    D.3.9.4EV Substance CodeSUB171907
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.2.5The 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 namefulvestrant
    D.3.2Product code L02BA03
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfulvestrant
    D.3.9.3Other descriptive nameFULVESTRANT
    D.3.9.4EV Substance CodeSUB13933MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    Hormone receptor positive, HER2-positive advanced breast cancer
    cáncer de mama HR+, HER2+ localmente avanzado o metastásico
    E.1.1.1Medical condition in easily understood language
    Metastatic breast cancer
    Cancer de Mama Metastasico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    The primary objective of this study is to compare the efficacy of abemaciclib plus trastuzumab plus fulvestrant and abemaciclib plus trastuzumab to standard-of-care single-agent chemotherapy of physician?s choice plus trastuzumab with respect to progression free survival (PFS).
    El objetivo principal de este estudio es comparar la eficacia de la politerapia con abemaciclib, trastuzumab y fulvestrant y de la politerapia con abemaciclib y trastuzumab con la de trastuzumab y el fármaco quimioterápico de referencia que determine el investigador, en lo que respecta a la supervivencia sin progresión (SSP)
    E.2.2Secondary objectives of the trial
    To review overall survival, objective response rate, duration of response, disease control rate, clinical benefit rate, safety and tolerability of abemaciclib, treatment impact on pain, disease symptoms and overall quality of life, pharmacokinetics of abemaciclib and relationship between abeamciclib, trastuzumab and fulvestrant exposure and clinical outcomes
    Tasa de supervivencia global; Tasa de respuestas objetivas; Duración de la respuesta; Tasa de control de la enfermedad; Tasa de beneficio clínico; Seguridad y tolerabilidad de abemaciclib en politerapia con trastuzumab y fulvestrant; Efecto en el dolor, los síntomas de la enfermedad y la calidad de vida global, para lo que se utilizará el Cuestionario breve modificado para la evaluación del dolor (m-BPI-sf) y el Cuestionario de calidad de vida ? Core 30 de la EORTC QLQ-C30 y las puntuaciones del estado de salud obtenidas a partir del cuestionario EQ-5D 5L; Farmacocinética de abemaciclib y sus metabolitos, fulvestrant y trastuzumab en la población destinataria; Relación entre la exposición a abemaciclib, trastuzumab y fulvestrant y la respuestaEl objetivo exploratorio de este estudio es:
    ? Explorar posibles biomarcadores relacionados con el mecanismo de acción de abemaciclib, el ciclo celular o la patogenia del cáncer de mama y su relación con el resultado clínico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have diagnosis of HR+, HER2+ metastatic breast cancer on the primary tumor or metastatic lesion
    2. Have unresectable locally advanced recurrent breast cancer or metastatic breast cancer
    3. Have adequate tumor tissue available and collected prior to randomization
    4. Have previously received at least two HER2 directed therapies for advanced disease
    5. Must have received trastuzumab emtansine (TDM1) in any disease setting
    6. Must have received a taxane in any disease setting
    7. Have discontinued all previous therapies for cancer (except trastuzumab) for at least 21 days for myelosuppressive agents or 14 days for non-myelosupprevice agents
    8. Have postmenopausal status
    9. Have performance status of 0 to 1 on the ECOG scale
    10. Must have LVEF of 50% or higher at baseline
    [1] diagnóstico de cáncer de mama HR+, HER2+ avanzado; [2] tener cáncer de mama localmente avanzado, recurrente e irresecable o cáncer de mama metastásico ; [3] disponer de una muestra de tejido aceptable (biopsia realizada recientemente o tejido conservado), obtenida antes de la aleatorización; [4] presentar enfermedad mensurable, no mensurable, o ambas, de acuerdo con los criterios RECIST, versión 1.1; [5] haber recibido anteriormente al menos 2 tratamientos dirigidos al HER2 para la enfermedad avanzada; deben haber recibido T-DM1 para la enfermedad en cualquier contexto; [6] deben haber recibido un taxano para la enfermedad en cualquier contexto; [7] pueden haber recibido cualquier hormonoterapia (salvo fulvestrant); [8] haber entrado en la posmenopausia (menopausia natural o por cirugía, o inducida por inhibición de la función ovárica; [9] tener una categoría funcional (CF) de 0 o 1 en la escala del Eastern Cooperative Oncology Group (ECOG); [10] en el período basal deben tener una fracción de eyección ventricular izquierda (FEVI) ? 50 %;
    E.4Principal exclusion criteria
    1. Have visceral crisis
    2. Known CNS metastases that are untreated, symptomatic or require steroids to control symptoms
    3. Received prior treatment with any CDK4 or CDK6 inhibitor
    4. Have had major surgery within 14 days prior to randomization
    5. Received treatment with a drug that has not received regulatory approval for any indication within 14 to 21 days of randomization for non-myelosuppressive or non-myelosupprevice agent, respectively
    6. Have serious preexisting medical conditions that would preclude participation in this study
    7. Have a history within the last 6 months of symptomatic congestive heart failure, myocardial infarction or unstable angina
    8. Have a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation or sudden cardiac arrest
    [19] tener crisis viscerales; [20] presentar metástasis en el sistema nervioso central (SNC) que no se hayan tratado, sean sintomáticas o requieran corticosteroides para controlar los síntomas; [21] haberse sometido a una intervención de cirugía mayor en el transcurso de los 14 días previos a la aleatorización, para posibilitar la cicatrización de la herida y de la zona donde se haya realizado la cirugía; [22] haber recibido tratamiento previo con cualquier inhibidor de la CDK 4 y la CDK 6; [23] haber recibido tratamiento con un fármaco que no haya sido aprobado por las autoridades sanitarias para ninguna indicación, en el transcurso de los 14 días (en el caso de los fármacos sin acción mielodepresora) o de los 21 días (en el caso de los fármacos mielodepresores) anteriores a la aleatorización; [24] tener una enfermedad preexistente grave que, de acuerdo con el criterio del investigador, impediría la participación en el estudio; [25] tener antecedentes, en el transcurso de los 6 últimos meses, de insuficiencia cardiaca congestiva sintomática, infarto de miocardio o angina inestable; [26] tener antecedentes personales, en el transcurso de los 12 últimos meses, de cualquiera de los procesos patológicos siguientes: sincope de origen cardiovascular, taquicardia ventricular, fibrilación ventricular o paro cardiaco súbito
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS)
    Supervivencia libre de progresion
    E.5.1.1Timepoint(s) of evaluation of this end point
    One planned primary analysis for PFS performed after 165 events have been observed. Within 28 days of randomization, baseline tumor assessment will be performed for each patient. Repeat scans will be done every 6 weeks for 36 weeks from first dose of therapy, then every 9 weeks and within 14 days of clinical progression.
    El análisis principal se realizará una vez que se hayan producido 165 eventos de SSP. Las evaluaciones basales del tumor se realizarán en el transcurso de los 28 días anteriores a la aleatorización de cada paciente. La prueba de imagen específica que se hubiera realizado en el período basal para evaluar las lesiones óseas debe repetirse, utilizando el mismo método, cada 6 semanas (± 3 días laborales) durante las 36 semanas posteriores a la primera dosis del tratamiento del estudio, y posteriormente cada 9 semanas (± 3 días laborales), así como en el transcurso de los 14 días posteriores al momento en el que se produzca la progresión clínica.
    E.5.2Secondary end point(s)
    OS rate, ORR, DoR, disease control., clinical benefit rate, safety and tolerability, impact on pain, disease symptom
    Supervivencia global; Tasa de respuestas objetivas; Duración de la respuesta; Tasa de control de la enfermedad; Tasa de beneficio clínico; Seguridad y Tolerabilidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to a total of 2 interim analysis and a final analysis for OS may be performed if PFS is significant for both abemaciclib arms. Health outcome scales are administered day 1 of each cycle.
    Podrán realizarse hasta 2 análisis provisionales y un análisis final de la SG, en los que se compararán los datos combinados de los 2 grupos de tratamiento con abemaciclib
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life, pain management and disease symptom control
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Trastuzumab plus physician's choice of standard of care single agent chemotherapy.
    E.8.2.4Number of treatment arms in the trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    France
    Germany
    Greece
    Italy
    Korea, Republic of
    Mexico
    Spain
    United Kingdom
    United States
    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
    Ultima visita ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 74
    F.4.2.2In the whole clinical trial 225
    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)
    Upon discontinuation the following will occur: physical exam; vitals; ECOG performance status; survival information; adverse events collection; concomitant medications; central hematology/chemistry and biomarker plasma sample collection; ECGl tumor tissue collection and health outcomes scales.
    Postdiscontinuation follow-up will be approximately every 9 weeks until the patient's death or overall study completion.
    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 Decision2016-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-15
    P. End of Trial
    P.End of Trial StatusOngoing
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