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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    Summary
    EudraCT Number:2020-004035-24
    Sponsor's Protocol Code Number:I3Y-MC-JPCW
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2023-10-16
    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 number2020-004035-24
    A.3Full title of the trial
    eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib plus Standard Adjuvant Endocrine Therapy in Participants with High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy
    eMonarcHER: Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo, en el que se evalúa abemaciclib con la hormonoterapia adyuvante de referencia en participantes con cáncer de mama HR+, HER-2+, de riesgo alto y con afectación ganglionar, que hayan completado un tratamiento adyuvante dirigido al HER2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    eMonarcHER: A Phase 3 Study of Abemaciclib plus Standard Adjuvant Endocrine Therapy in Participants with High-Risk, Node Positive, HR+, HER2+ Breast Cancer.
    eMonarcHER: Un estudio de fase 3 en el que se evalúa abemaciclib con la hormonoterapia adyuvante de referencia en participantes con cáncer de mama HR+, HER-2+, de riesgo alto y con afectación ganglionar
    A.4.1Sponsor's protocol code numberI3Y-MC-JPCW
    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 organisationEli Lilly Corl Ltd
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressIsland House, Eastgate Road, Eastgate Business Park, Little Island
    B.5.3.2Town/ cityCo. Cork
    B.5.3.3Post codeT45 KD39
    B.5.3.4CountryIreland
    B.5.4Telephone number34918362958
    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 Yes
    D.2.1.1.1Trade name Verzenios
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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 INNLY2835219
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    High-Risk, Node-Positive, HR+, HER2+ Breast Cancer
    Cáncer de mama HR+, HER-2+, de riesgo alto y con afectación ganglionar
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    Cáncer de mama
    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 SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10006199
    E.1.2Term Breast cancer stage I
    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
    To compare the efficacy of abemaciclib plus physician’s choice ET versus placebo plus physician’s choice ET in the study population.
    Comparar la eficacia de abemaciclib y la hormonoterapia de elección del médico con la de un placebo y la hormonoterapia de elección del médico en la población del estudio.
    E.2.2Secondary objectives of the trial
    To compare the efficacy of abemaciclib plus ET versus placebo plus physician’s choice ET in the study population. (*)To assess the safety profile of abemaciclib plus physician’s choice ET versus placebo plus ET in the
    study population. (*)To evaluate participant-reported symptoms, function and global health status/QOL (EORTC QLQ-C30)
    To evaluate health status in the study population to inform decision
    modeling for health economic evaluation using the EQ-5D 5L.
    To evaluate the PK of abemaciclib
    Comparar la eficacia de abemaciclib y la hormonoterapia de elección del médico con la de un placebo y la hormonoterapia de elección del médico en la población del estudio.
    (*) Comparar el perfil de seguridad de abemaciclib y la hormonoterapia de elección del médico con el de un placebo y la hormonoterapia de elección del médico en la población del estudio.
    (*) Evaluar los síntomas percibidos por el participante, la función y el estado global de salud / la calidad de vida (EORTC QLQ-C30). Evaluar el estado de salud en la población del estudio para tomar decisiones fundamentadas sobre modelos para la evaluación de economía sanitaria, utilizando el cuestionario EQ-5D-5L. Evaluar la FC de abemaciclib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • The participant has confirmed HR+, HER2-positive (HER2+) in initial diagnostic tissue, early invasive breast cancer without evidence of disease recurrence or distant metastases
    • The participant must have undergone definitive surgery of the primary breast tumor(s) AND must be randomized within 18 months of primary breast cancer surgery.
    • Have tumor tissue from breast (preferred) or lymph node
    • Have received a minimum of four cycles of chemotherapy in either the neoadjuvant or adjuvant setting per standard of care therapy
    • Participants have completed up to one year of standard HER2-targeted therapy without evidence of disease recurrence (neoadjuvant/adjuvant combined duration).
    • Eligible adjuvant regimens are as follows:
    o Single agent adjuvant TDM-1 or
    o Adjuvant pertuzumab in combination with trastuzuma
    • Participant must have high risk disease is defined by 1 of the following:
    o For participants who were treated with neoadjuvant chemotherapy administered with trastuzumab-based therapy: The presence axillary nodal disease detected pathologically in the surgical specimen; the presence of residual disease in the breast surgical specimen may also be detected pathologically but is not required.
    o For participants who were not treated with neoadjuvant therapy: Participant’s cancer must be axillary node positive (microscopic and macroscopic tumor involvement are allowed; ipsilateral internal mammary and supraclavicular lymph nodes are allowed, but will not count toward the number of positive lymph nodes) and fulfill one of the following criteria:
     Pathological tumor involvement in ≥4 ipsilateral axillary lymph nodes
    OR
    o Pathological tumor involvement in 1 to 3 ipsilateral axillary lymph node(s) and at least 1 of the following criteria:
    o Histological Grade 2 or Grade 3 as defined by a combined score per the modified Bloom Richardson grading system (Elston and Ellis 1991), also known as the Nottingham scale, or equivalent following discussion with the Lilly CRP/CRS
    o Primary invasive tumor size ≥5 cm determined pathologically.
    • La participante presenta cáncer de mama invasivo incipiente, con expresión de receptores hormonales (HR+) y sobreexpresión del receptor HER2 (HER2+), sin signos de enfermedad recurrente ni de metástasis a distancia
    • La participante debe haberse sometido a una cirugía definitiva de los tumores primarios en la mama Y debe haber sido aleatorizada en el transcurso de los 18 meses posteriores a la cirugía del cáncer primario de mama.
    • Debe contarse con tejido tumoral de la mama (preferente) o de un ganglio linfático
    • Haber recibido al menos cuatro ciclos de quimioterapia como tratamiento neoadyuvante o adyuvante, de acuerdo con las normas asistenciales
    • Las participantes deben haber completado hasta un año de un tratamiento de referencia dirigido al HER2 y no presentar signos de recurrencia de la enfermedad (durante la totalidad del tratamiento neoadyuvante / adyuvante).
    • Los tratamientos adyuvantes permitidos son los siguientes:
    o TDM-1 en monoterapia como tratamiento adyuvante, o
    o Pertuzumab en combinación con trastuzumab como tratamiento adyuvante
    • La participante debe presentar enfermedad de alto riesgo, de acuerdo con 1 de los criterios siguientes:
    o En el caso de las participantes que hubieran recibido quimioterapia neoadyuvante que incluyera el medicamento trastuzumab: presencia de enfermedad en los ganglios linfáticos axilares de acuerdo con el examen anatomopatológico de la pieza quirúrgica; en el examen anatomopatológico también puede determinarse la presencia de enfermedad residual en la pieza quirúrgica extraída de la mama, aunque no es un requisito.
    o En el caso de las participantes que no hubieran recibido tratamiento neoadyuvante: el cáncer de la participante debe afectar a los ganglios linfáticos axilares (se permite la afectación tanto microscópica como macroscópica; si bien se permite que la paciente presente afectación de los ganglios linfáticos mamarios internos ipsilaterales y supraclaviculares, estos no se contabilizarán a la hora de determinar el número de ganglios linfáticos afectados) y debe cumplirse uno de los criterios siguientes:
     Afectación patológica con el tumor en ≥4 ganglios linfáticos axilares ipsilaterales O
     Afectación patológica con el tumor en 1-3 ganglios linfáticos axilares ipsilaterales y al menos 1 de los criterios siguientes:
    • Grado histológico de 2 o 3, de acuerdo con la puntuación combinada del sistema de estadificación de Bloom Richardson modificado (Elston y Ellis 1991), también conocido como la “escala de Nottingham”, o un sistema equivalente (si así se acuerda con el CRP/CRS de Lilly)
    Tamaño del tumor invasivo primario ≥5 cm de acuerdo con el examen anatomopatológico.
    E.4Principal exclusion criteria
    • Participant has breast cancer with any of the following features:
    o Disease recurrence or distant metastatic disease (including contralateral axillary lymph nodes)
    o Lymph node-negative status
    o Pathological complete response (pCR) from any prior systemic treatments for early breast cancer
    o Inflammatory breast cancer
    • Participants with a history of previous breast cancer, with the exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago. Participants with a history of contralateral DCIS treated by local regional therapy at any time may be eligible.
    • The participant has previously received treatment with:
    o Any CDK4 and CDK6 inhibitor
    o Adjuvant treatment with immunotherapy, tucatinib, neratinib, investigational HER2 directed therapy, or DS8201 for treatment of breast cancer.
    o ET (i.e., tamoxifen, raloxifene or AI) for breast cancer prevention (without diagnosis of breast cancer).
    o Additional chemotherapy, anti-cancer ET, or HER2-targeted therapy beyond standard of care therapy for their breast cancer at study enrollment
    o Bone-targeting agents prescribed as cancer modifying treatment agent
    • La participante presenta alguna de las características siguientes en el cáncer de mama:
    o Recurrencia de la enfermedad o metástasis a distancia (incluidos los ganglios linfáticos axilares contralaterales)
    o Ausencia de afectación en los ganglios linfáticos
    o Haber presentado una respuesta patológica completa (RpC) a alguno de los tratamientos sistémicos previos para el cáncer de mama incipiente
    o Presencia de cáncer de mama inflamatorio
    • Participantes con antecedentes de cáncer de mama previo, salvo los casos de carcinoma ductal ipsilateral in situ que se haya tratado exclusivamente con tratamiento locorregional hace ≥5 años. Las participantes con antecedentes de carcinoma ductal contralateral in situ que en algún momento hayan recibido tratamiento locorregional podrán participar.
    • La participante ha recibido tratamiento anteriormente con:
    o Cualquier inhibidor de la CDK4 o la CDK6
    o Tratamiento adyuvante con inmunoterapia, tucatinib, neratinib, un tratamiento en investigación dirigido al HER2 o DS8201 para el tratamiento del cáncer de mama.
    o Hormonoterapia (por ejemplo, tamoxifeno, raloxifeno o inhibidores de la aromatasa) para la prevención del cáncer de mama (sin diagnóstico de cáncer de mama).
    o Haber recibido en el momento del reclutamiento en el estudio quimioterapia adicional, hormonoterapia antineoplásica o un tratamiento dirigido al HER2 que no formen parte del tratamiento de referencia para el cáncer de mama.
    Fármacos con efectos óseos recetados como tratamientos modificadores del cáncer.
    E.5 End points
    E.5.1Primary end point(s)
    To compare invasive disease free survival (IDFS) for abemaciclib plus physician’s choice ET versus placebo plus physician’s choice ET in the study population.
    Comparar la supervivencia sin enfermedad invasiva (SSEI) en la población de estudio cuando se administra abemaciclib y la hormonoterapia de elección del médico y cuando se administra un placebo y la hormonoterapia de elección del médico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After approximately 50 months from first participant randomized when approximately 324 IDFS events have occurred.
    Cuando hayan transcurrido unos 50 meses desde la fecha en la que se aleatorizara a la primera participante y se hayan producido unos 324 eventos de SSEI.
    E.5.2Secondary end point(s)
    • Efficacy endpoints: overall survival (OS), distant relapse-free survival (DRFS)
    • Safety endpoints, including but not limited to TEAEs, SAEs, hospitalizations, clinical laboratory tests, vital signs, and physical examinations
    • To evaluate participant-reported symptoms, function and global health status/QOL based on EORTC QLQ-C30 scales
    • To evaluate health status in the study population to inform decision modeling for health economic evaluation using the EQ-5D 5L index score
    • To evaluate the PK of abemaciclib based on abemaciclib concentrations
    • Criterios de valoración de la eficacia: supervivencia global (SG), supervivencia sin recurrencia a distancia (SSRD)
    • Criterios de valoración de la seguridad, entre, los AAAT, los AAG, las hospitalizaciones, los resultados de los análisis clínicos, las constantes vitales y las exploraciones físicas
    • Evaluar los síntomas percibidos por el participante, la función y el estado global de salud / la calidad de vida, de acuerdo con las escalas EORTC QLQ-C30
    • Evaluar el estado de salud en la población de estudio para tomar decisiones fundamentadas sobre modelos para la evaluación de economía sanitaria, utilizando la puntuación de referencia del EQ-5D 5L
    • Evaluar la FC de abemaciclib de acuerdo con las concentraciones de este fármaco
    E.5.2.1Timepoint(s) of evaluation of this end point
    After approximately 50 months from first participant randomized when approximately 324 IDFS events have occurred.
    At the end of trial.
    Cuando hayan transcurrido unos 50 meses desde la fecha en la que se aleatorizara a la primera participante y se hayan producido unos 324 eventos de SSEI. Al final del estudio.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned35
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA203
    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
    Switzerland
    Taiwan
    Australia
    Brazil
    China
    Israel
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    United Kingdom
    United States
    Austria
    Belgium
    Finland
    France
    Germany
    Greece
    Hungary
    Italy
    Romania
    Spain
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years10
    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: 2205
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 245
    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 state206
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 757
    F.4.2.2In the whole clinical trial 2450
    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)
    After the on-study intervention period, standard adjuvant ET should continue for a duration of 3 to 8 additional years, for a total duration of up to 10 years, if deemed medically appropriate.
    Standard approved adjuvant ET is per physician’s choice (such as, tamoxifen or an aromatase inhibitor, with or without ovarian function suppression per standard practice).
    Si se considera adecuado desde un punto de vista médico, tras el período de tratamiento del estudio, continuará administrándose la hormonoterapia adyuvante de referencia durante 3-8 años adicionales (duración total de 10 años).
    El médico será quien decida la hormonoterapia adyuvante de referencia (por ejemplo, tamoxifeno o un inhibidor de la aromatasa, con o sin la administración de un inhibidor de la función ovárica, de acuerdo con la práctica habitual).
    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 Decision2021-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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