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    Summary
    EudraCT Number:2021-000079-35
    Sponsor's Protocol Code Number:J2J-OX-JZLC
    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:2021-06-11
    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 number2021-000079-35
    A.3Full title of the trial
    EMBER-3: A Randomized, Open-Label, Phase 3 Study of LY3484356 vs Investigator’s Choice of Endocrine Therapy, in Patients with Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated with Endocrine Therapy
    EMBER-3: Estudio de fase 3, aleatorizado, abierto, en el que se compara LY3484356 con la hormonoterapia de preferencia del investigador en pacientes con cáncer de mama localmente avanzado o metastásico, con expresión de receptores estrogénicos y sin sobreexpresión del receptor HER2, que anteriormente han recibido hormonoterapia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EMBER-3: A Study of LY3484356 vs Investigator’s Choice Endocrine therapy, in Patients with ER+, HER2- Breast Cancer
    EMBER-3: Un estudio en el que se compara LY3484356 con la hormonoterapia de preferencia del investigador en pacientes con cáncer de mama ER+, HER2
    A.3.2Name or abbreviated title of the trial where available
    Ember-3
    Ember-3
    A.4.1Sponsor's protocol code numberJ2J-OX-JZLC
    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
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    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 nameLY3484356
    D.3.2Product code LY3484356
    D.3.4Pharmaceutical form 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 INNLY3484356
    D.3.9.3Other descriptive nameLY3484356 tosylate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Breast Neoplasms, Neoplasm Metastasis
    Neoplasias en la mama, metástasis de neoplasias
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the progression-free survival of LY3484356 (Arm A) to the standard comparator of Investigator’s Choice Endocrine Therapy of either fulvestrant or exemestane (Arm B)
    Comparar la supervivencia sin progresión con LY3484356 (grupo A) y con la hormonoterapia de preferencia del investigador (fulvestrant o exemestano [grupo B])
    E.2.2Secondary objectives of the trial
    •To compare OS of Arm A to Arm B
    •To compare other efficacy objectives of Arm A to Arm B
    •To assess the safety and tolerability of each treatment arm
    •To evaluate the effectiveness of Arm A compared to Arm B based on PROs of pain using the Worst Pain NRS
    •To assess the PK of LY3484356
    •Comparar la SG observada en el grupo A con la observada en el grupo B
    •Comparar otros objetivos de eficacia entre el grupo A y el grupo B
    •Evaluar la seguridad y la tolerabilidad de cada grupo de tratamiento
    •Evaluar la eficacia real observada en el grupo A con la observada en el grupo B en función de los RPP relativos al dolor de acuerdo con la EVN del dolor más intenso
    •Evaluar la FC de LY3484356
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ∙ Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer
    ∙ Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a CDK4/6 inhibitor.
    ∙ Must be deemed appropriate for treatment with endocrine therapy
    ∙ If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
    ∙ Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease)
    ∙ Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
    ∙ Have adequate renal, hematologic, and hepatic organ function
    ∙ Must be able to swallow capsules/tablets
    ∙ Diagnóstico de cáncer de mama ER+ y HER2- localmente avanzado o metastásico
    ∙ Presentar enfermedad que haya progresado durante el tratamiento con un inhibidor de la aromatasa, bien en monoterapia o en combinación con un inhibidor de las CDK4/6, o después de dicho tratamiento
    ∙ Debe considerarse que el paciente es tributario de hormonoterapia
    ∙ Las mujeres deben ser posmenopáusicas, de forma natural o por una intervención quirúrgica, o por recibir un inhibidor de la función ovárica
    ∙ Presencia de enfermedad evaluable de acuerdo con los criterios RECIST (enfermedad mensurable y/o enfermedad exclusivamente ósea no mensurable)
    ∙ Presentar una categoría funcional de 0 o 1 en la Escala del Eastern Cooperative Oncology Group (Oken et al. 1982)
    ∙ Presentar unas funciones renal, hematológica y hepática aceptables
    ∙ Ser capaz de ingerir cápsulas o comprimidos
    E.4Principal exclusion criteria
    ∙ Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor
    ∙ Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease.
    ∙ Have symptomatic or untreated brain metastasis.
    ∙ Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
    ∙ Known allergic reaction against any of the components of the study treatment
    ∙ Haber recibido anteriormente quimioterapia (salvo quimioterapia neoadyuvante/adyuvante), fulvestrant, cualquier otro tratamiento en fase de investigación dirigido a los receptores de estrógenos (tanto degradantes selectivos de los receptores de estrógenos [DSRE] como otro tipo de tratamiento) o cualquier inhibidor de PI3K, mTOR o AKT
    ∙ Presentar crisis visceral, diseminación linfangítica en el pulmón o cualquier signo de enfermedad leptomeníngea
    ∙ Presentar metástasis cerebrales sintomáticas o sin tratar
    ∙ Presentar enfermedades preexistentes graves que, en opinión del investigador, podrían impedir su participación en este estudio
    ∙ Haber sufrido una reacción alérgica a alguno de los componentes del tratamiento del estudio
    E.5 End points
    E.5.1Primary end point(s)
    1.Progression Free Survival (PFS) by investigator assessment
    1. Supervivencia sin progresión (SSP) según la evaluación del investigador
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)
    1. Período comprendido entre la fecha de aleatorización y la fecha en la que se documente por primera vez la progresión de la enfermedad o la fecha de la muerte por cualquier causa (se estima que como máximo será de 3 años)
    E.5.2Secondary end point(s)
    2. Overall Survival (OS)
    3. Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)
    4. Duration of Response (DoR)
    5. Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for greater than or equal to (≥) 24 weeks
    6. PFS by Estrogen Receptor 1 Gene (ESR1) Mutation Status in Plasma
    Investigator-assessed PFS by ESR1 mutation status in plasma
    7. Progression Free Survival (PFS) by blinded independent review
    8. Patient Reported Outcomes (PRO): Time to Worsening of "Worst Pain"
    Measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single item, participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine."
    9. Pharmacokinetics (PK): Steady State Plasma Concentrations of LY3484356
    2. Supervivencia global (SG)
    3. Tasa de respuestas objetivas (TRO): porcentaje de pacientes que alcancen una mejor respuesta global confirmada de respuesta completa (RC) o respuesta parcial (RP)
    4. Duración de la respuesta (DdR)
    5. Tasa de beneficio clínico (TBC): Porcentaje de participantes que alcancen una mejor respuesta global de RC, RP o enfermedad estable durante ≥ 24 semanas.
    6. SSP de acuerdo con el estado mutacional del gen 1 del receptor de estrógenos (ESR1) en el plasma y la evaluación del investigador; SSP en función del estado mutacional del ESR1 en el plasma
    7. Supervivencia sin progresión (SSP) de acuerdo con una revisión independiente enmascarada
    8. Resultados percibidos por el paciente (RPP): tiempo transcurrido hasta el empeoramiento al “dolor más intenso” de acuerdo con la escala de valoración numérica (EVN) del dolor más intenso. La EVN es una escala horizontal de un único ítem, de 11 puntos, que completa el paciente, en la que 0 representa “ausencia de dolor”, y 10, “dolor más intenso como pueda imaginarse”.
    9. Farmacocinética (FC): concentraciones plasmáticas de LY3484356 en el estado de equilibrio
    E.5.2.1Timepoint(s) of evaluation of this end point
    2. Randomization until death from any cause (estimated as up to 5 years)
    3. Randomization until measured progressive disease (estimated as up to 1 year)
    4. Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years)
    5. Randomization until measured progressive disease (estimated as up to 1 year)
    6. Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)
    7. Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)
    8. Screening through follow-up (estimated as up to 3 years)
    9. Cycle 2 to Cycle 4 (cycle = 28 days)
    2.Dsd fech d aleatoriz hst fech d muerte x cualq causa(estm máx será 5añs)
    3.Dsd fech d aleatoriz hst fech en la q se determine la progres. d la enfermedd(estm máx será 1año)
    4.Dsd fech en q se alcance la RC/RP hst la fech d la progres. d la enfermedd o muert x cualq causa(estm máx será 3añs)
    5.Dsd fech d aleatoriz hsta fech en la q s mida la progres. d la enfermedd (estim máx será d 1año)
    6.Períod comprend ntre la fech aleatoriz y fech en la q se docment x 1vez la progres. d la enfermedd o la fech d la muerte x cualq causa(estm máx será 3añs)
    7.Períod comprend ntre fech aleatoriz y fecha en la q se docment x 1vez la progres. d la enfermedd o fech d la muerte x cualq causa(estim máx será 3añs)
    8.Dsd seleccn hst el seguimient(estim máx será 3añs)
    9.Dsd cicl2 hst cicl4, cicl=28dias
    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 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
    Elección de la terapia endocrina por parte del investigador
    Investigator’s Choice of Endocrine Therapy
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    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
    Australia
    Brazil
    China
    India
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    Taiwan
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    France
    Germany
    Greece
    Italy
    Netherlands
    Spain
    Czechia
    Argentina
    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 in the study or last scheduled procedure for the last participant in the trial globally
    LVLS en el estudio o el último procedimiento programado para el último participante en el ensayo a nivel mundial
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 state39
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 119
    F.4.2.2In the whole clinical trial 500
    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)
    Patients receiving study treatment and experiencing ongoing clinical benefit may continue to receive study treatment after completion of the study until 1 of the criteria of discontinuation is met.
    Los pacientes que reciban el tratamiento del estudio y continúen experimentando beneficio clínico podrán continuar recibiéndolo una vez terminado el estudio hasta que se constate 1 de los criterios de interrupción.
    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 Decision2021-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-07
    P. End of Trial
    P.End of Trial StatusOngoing
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