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    Summary
    EudraCT Number:2013-003084-61
    Sponsor's Protocol Code Number:CLEE011A2301
    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:2013-12-27
    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 number2013-003084-61
    A.3Full title of the trial
    A randomized double-blind, placebo-controlled study of LEE011 in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer who received no prior therapy for advanced disease
    Estudio aleatorizado, doble ciego, controlado con placebo, de LEE011 en combinación con letrozol para el tratamiento de mujeres postmenopáusicas con cáncer de mama avanzado con receptor hormonal positivo, HER2-negativo que no han recibido terapia previa para la enfermedad avanzada
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy and safety of LEE011 in postmenopausal women with advanced breast cancer.
    Estudio de eficacia y seguridad de LEE011 mujeres postmenopáusicas con cáncer de mama avanzado.
    A.3.2Name or abbreviated title of the trial where available
    MONALEESA-2
    MONALEESA-2
    A.4.1Sponsor's protocol code numberCLEE011A2301
    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 SponsorNovartis Farmacéutica, 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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointDepartamento Médico Oncología (GMO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34900353036
    B.5.5Fax number34932479903
    B.5.6E-maileecc.novartis@novartis.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 nameLEE011 200 mg
    D.3.2Product code LEE011 200 mg
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLEE011
    D.3.9.1CAS number LEE011
    D.3.9.2Current sponsor codeLEE011
    D.3.9.3Other descriptive nameLEE011
    D.3.9.4EV Substance CodeSUB31644
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 nameLetrozol
    D.3.2Product code Letrozol
    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 INNLETROZOL
    D.3.9.1CAS number 112809-51-5
    D.3.9.2Current sponsor codeLETROZOL
    D.3.9.3Other descriptive nameLETROZOL
    D.3.9.4EV Substance CodeSUB08444MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 placeboCapsule, hard
    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
    HR+, HER2- advanced breast cancer
    Cáncer de mama avanzado con receptor hormonal positivo
    E.1.1.1Medical condition in easily understood language
    advanced breast cancer
    Cáncer de mama avanzado
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10072737
    E.1.2Term Advanced breast cancer
    E.1.2System Organ Class 100000004864
    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 progression-free survival between LEE011 in combination with letrozole to placebo plus letrozole among postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer who received no prior therapy for advanced disease.
    Comparar la supervivencia libre de progresión entre LEE011 en combinación con letrozol con placebo con letrozol en mujeres postmenopáusicas con cáncer de mama avanzado HER2-negativo, HR+ que no han recibido terapia previa para la enfermedad avanzada utilizando los RECIST 1.1.
    E.2.2Secondary objectives of the trial
    Key secondary:
    - To compare the two treatment arms with respect to overall survival.

    Other secondary:
    ? To evaluate the two treatment arms with respect to overall response rate and clinical benefit rate
    ? To evaluate the two treatment arms with respect to time to deterioration of ECOG performance status
    ? To evaluate the safety and tolerability of LEE011 in combination with letrozole
    ? To evaluate patient reported outcomes for health-related quality of life in the two treatment arms
    Secundarios principales: ? Comparar los dos brazos de tratamiento con respecto a la supervivencia global.
    Objetivos secundarios: ?Evaluar los dos brazos de tratamiento con respecto a la tasa de respuesta global con los RECIST 1.1 y la tasa de beneficio clínico como el porcentaje de pacientes con respuesta completa, respuesta parcial o enfermedad estable que se prolongue 24 semanas o más.
    ?Evaluar los dos brazos de tratamiento con respecto al tiempo hasta el deterioro del ECOG.
    ?Evaluar la seguridad y tolerabilidad de LEE011 en combinación con letrozol medido con la frecuencia/severidad de los acontecimientos adversos y anomalías de laboratorio.
    ?Evaluar los resultados notificados por la paciente de la calidad de vida relacionada con la salud en los dos brazos de tratamiento, como el tiempo hasta el deterioro definitivo del 10% y, cambio respecto a la puntuación basal, en la puntuación de la escala de estado de salud general/calidad de vida del QLQ-C30 de la EORTC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Women with advanced (recurrent or metastatic) breast cancer who received no prior therapy for advanced disease.
    2. Patient is postmenopausal. Postmenopausal status is defined either by:
    ? Prior bilateral oophorectomy
    ? Age ?60
    ? Age <60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range
    Note: For women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol are needed to ensure postmenopausal status. Ovarian radiation or treatment with a luteinizing hormone-releasing hormone agonist (LH-RHa) (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression in this trial.
    3. No prior systemic anti-cancer therapy for advanced disease.
    4. Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.
    5. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
    6. Patient must have either:
    ? Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria or,
    ? At least one predominantly lytic bone lesion
    7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

    Other inclusion criteria as defined by protocol may apply.
    1. Mujeres con cáncer de mama avanzado (metastásico o recurrente locorregionalmente) no aptas para terapia curativa.
    2. Ninguna terapia antineoplásica sistémica previa para la enfermedad avanzada.
    3. Pacientes postmenopáusicas. El estado postmenopáusico se define con:
    ? Ooforectomía bilateral previa
    ? Edad ?60
    ? Edad <60 y amenorrea durante 12 meses o más (en ausencia de quimioterapia, tamoxifeno, toremifeno o supresión de ovarios) y niveles de FSH y de estradiol dentro del rango postmenopáusico según el rango normal local.
    Nota: Para mujeres con amenorrea inducida por terapia, son necesarias mediciones en serie de FSH y/o estradiol para asegurar el estado postmenopáusico. En este ensayo, la radiación de ovarios o el tratamiento con un agonista de la hormona de liberación de hormona luteinizante (LH-RH) (acetato de goserelina o acetato de leuprolida) no está permitida para inducción de supresión de ovarios.
    4. Pacientes con diagnóstico confirmado histológica y/o citológicamente de cáncer de mama con receptor estrogénico positivo y/o receptor progesterónico positivo por el laboratorio local.
    5. Pacientes con cáncer de mama HER2-negativo definido como un test de hibridización in situ negativo o un estado de IHC de 0, 1+ o 2+. Si el IHC es 2+, se requiere un test de hibridización in situ negativo (FISH, CISH o SISH) por el análisis de laboratorio local.
    6. Enfermedad medible, es decir, por lo menos una lesión medible según los criterios RECIST 1.1 o, por lo menos una lesión ósea predominantemente lítica
    7. ECOG de 0 ó 1
    8. Función orgánica y de la médula ósea adecuada, definido con los siguientes valores de laboratorio:
    ? Recuento absoluto de neutrófilos ? 1.5 × 109/L
    ? Plaquetas ? 100 x 109/L
    ? Hemoglobina ? 9.0 g/dl
    ? Potasio, sodio, calcio (corregido para albúmina sérica), magnesio y fósforo dentro de los límites de normalidad del laboratorio central
    ? INR ?1.5
    ? Creatinina sérica dentro de los límites de normalidad del laboratorio central
    ? En ausencia de metástasis hepáticas, ALT y AST inferiores a 2.5 x LSN. Si la paciente presenta metástasis hepáticas, la ALT y la AST deberían ser < 5 x LSN.
    ? Bilirrubina sérica total < LSN; o bilirrubina total ? 3.0 x LSN, con bilirrubina directa dentro del rango de normalidad del laboratorio central en pacientes con Síndrome de Gilbert bien documentado
    E.4Principal exclusion criteria
    1. Patient who received any CDK4/6 inhibitor.
    2. Patient who received any prior anti-cancer therapy (including chemotherapy) for advanced disease with the exception of surgery.
    Note:
    ? Patients who received (neo) adjuvant therapy for breast cancer are eligible. The
    disease free interval since the last adjuvant treatment must be greater than 12 months prior to randomization. Prior therapy with letrozole or anastrozole in the (neo) adjuvant setting is permitted if the disease free interval is greater than 12 months from the completion of treatment.
    3. Patient is currently receiving any of the following medications:
    ? That are known strong inducers or inhibitors of CYP3A4.
    ? That have a known risk to prolong the QT interval or induce Torsades de Pointes.
    ? That have a narrow therapeutic window and are predominantly metabolized through CYP3A4.
    4. Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
    5. Patient has active cardiac disease or a history of cardiac dysfunction including any of the following:
    ? History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry
    ? History of documented congestive heart failure (New York Heart Association
    functional classification III-IV)
    ? Documented cardiomyopathy
    ? Patient has a Left Ventricular Ejection Fraction (LVEF) < 50% as determined by
    Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)
    ? History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal
    arrhythmias, or conduction abnormality in the previous 12 months.
    ? On screening, any of the following cardiac parameters: bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval >109 msec, or QTcF >450 msec.
    ? Systolic blood pressure >160 or <90 mmHg

    Other exclusion criteria as defined by protocol may apply.
    1. Pacientes que hayan recibido algún inhibidor de CDK4/6.
    2. Pacientes con hipersensibilidad conocida a algún excipiente de LEE011 o de letrozol
    3. Pacientes con cáncer de mama inflamatorio
    4. Pacientes que hayan recibido terapia antineoplásica previa (incluyendo quimioterapia) para la enfermedad avanzada, con la excepción de cirugía.
    Nota:
    ? Las pacientes que recibieron terapia (neo) adyuvante para el cáncer de mama son elegibles. El intervalo libre de enfermedad desde el último tratamiento adyuvante deberá ser superior a 12 meses antes de la aleatorización. Se permite terapia previa con letrozol o anastrozol en el marco (neo) adyuvante si el intervalo sin enfermedad es superior a 12 meses desde la finalización del tratamiento.
    5. Pacientes con una enfermedad maligna concurrente o enfermedad maligna dentro de los 3 años de la aleatorización, con la excepción de carcinoma cutáneo de células escamosas o basales, no melanoma, adecuadamente tratado o cáncer del cuello del útero extirpado curativamente.
    6. Pacientes con metástasis en el SNC.
    7. Pacientes con deterioro de la función gastrointestinal (GI) o enfermedad GI que pueda alterar significativamente la absorción de las medicaciones del estudio (por ejemplo, enfermedades ulcerosas, náuseas incontroladas, vómitos, diarrea, síndrome de mala absorción o resección del intestino delgado).
    8. Pacientes con antecedentes conocidos de infección por VIH (la prueba no es obligatoria)
    9. Pacientes con otras condiciones médicas concomitantes graves y/o incontroladas que pudiesen, a juicio del investigador, contraindicar la participación de la paciente en el estudio clínico (por ejemplo, pancreatitis crónica, hepatitis crónica activa, etc.).
    10. Pacientes con enfermedad cardiaca activa o antecedentes de disfunción cardíaca que incluya algo de lo siguiente:
    ? Antecedentes de angina de pecho, pericarditis sintomática o infarto de miocardio dentro de los 12 meses antes de la entrada en el estudio
    ? Antecedentes de insuficiencia cardíaca congestiva documentada (clasificación III-IV funcional de la Asociación de Cardiología de Nueva York)
    ? Cardiomiopatía documentada
    ? Pacientes con fracción de eyección ventricular izquierda (LVEF) < 50%, determinada con ventriculografía isotópica (MUGA) o ecocardiograma (ECO)
    ? Antecedentes de cualquier arritmia cardíaca, por ejemplo, arritmias ventriculares, supraventriculares, nodales o anomalías de conducción en los últimos 12 meses
    ? En la selección, alguno de los siguientes parámetros cardíacos: bradicardia (frecuencia cardíaca < 50 en reposo), taquicardia (frecuencia cardíaca > 90 en reposo), intervalo PR > 220 ms, intervalo QRS >109 ms, o QTcF >450 ms.
    ? Presión arterial sistólica > 160 o < 90 mmHg
    11. Pacientes que actualmente estén recibiendo alguna de las siguientes medicaciones (véase Suplemento 1 para los detalles):
    ? Que se conozca que son inhibidores o inductores potentes de CYP3A4.
    ? Que posean un riesgo conocido de prolongar el intervalo QT o de inducir Torsades de Pointes.
    ? Que posean un estrecho índice terapéutico y que sean metabolizadas predominantemente por el CYP3A4.
    12. Pacientes que hayan sido sometidas a cirugía mayor dentro de los 14 días antes de iniciar la medicación del estudio o que no se hayan recuperado de los efectos secundarios principales.
    13. Pacientes que actualmente reciban o han recibido corticosteroides sistémicos ? 2 semanas antes del inicio de la medicación del estudio o que no se hayan recuperado completamente de los efectos secundarios de dicho tratamiento.
    Nota: Se permiten los siguientes usos de corticosteroides: dosis únicas; aplicaciones tópicas (por ejemplo, erupción), inhaladores (por ejemplo, enfermedades obstructivas de las vías aéreas respiratorias), colirios o inyecciones locales (por ejemplo, intraarticulares)
    14. Pacientes que utilicen concomitantemente otros agentes antineoplásicos.
    15. Pacientes que hayan recibido radioterapia ? 4 semanas o radiación de campo limitado para paliación ? 2 semanas antes de la aleatorización o que no se hayan recuperado a grado 1 o mejor de los efectos secundarios relacionados de dicha terapia (con la excepción de alopecia) y/o cuya médula ósea haya sido irradiada ? 30%.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS will be assessed via local radiology assessment according to RECIST 1.1
    Supervivencia libre de progresión utilizando los RECIST 1.1, evaluado por los investigadores/radiólogos locales
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to approximately 25 months
    Hasta aproximadamente 25 meses
    E.5.2Secondary end point(s)
    Key secondary:
    - overall survival, defined as time from randomization to the date of death from any cause

    Other secondary:
    ? ORR, defined as proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST
    ? Clinical benefit rate (CBR), defined as the proportion of patients with a best overall repsonse of complete response (CR) or partial response (PR) or stable disease (SD) lasting more than 24 weeks as defined in RECIST 1.1
    ? time to definitive deterioration of ECOG performance status in one category of the score, defined as the time from date of randomization to the date of event, which is defined as at least one score lower than the baseline
    ? safety and tolerability of LEE001, determined by type, frequency and severity of Adverse Events per CTCAE version 4.03 and type, frequency and severity of laboratory toxicities per CTCAE version 4.03
    ? Time to definitive 10% deterioration in the global health status/QOL scale score of the EORTC QLQ-C30, defined as the time from the date of randomization to the date of event, which is defined as at least 10% relative to baseline worsening of the corresponding scale score (without further improvement above the threshold) or death due to any cause
    ? QTc interval, defined as time between the start of the Q wave and the of the T wave corrected for heart rate
    ?Supervivencia global
    Otros secundarios:
    ? TRG definida con los RECIST 1.1. TBC, definido como el porcentaje de pacientes con RC, RP según los RECIST o EE que dure 24 semanas o más
    ? Estado funcional del ECOG
    ? Seguridad y tolerabilidad
    ? Tiempo hasta el deterioro del 10% en el estado de salud global/escala de puntuación de QOL del QLQ-C30 de la EORTC
    ? Cambio respecto a la basal en el estado de salud global/escala de puntuación de QOL del QLQ-C30 de la EORTC
    E.5.2.1Timepoint(s) of evaluation of this end point
    OS: up to approximately 69 months
    ORR: up to approximately 25 months
    CBR: up to approximately 25 months
    ECOG performance status deterioration: up to approximately 25.5 months
    safety and tolerability: up to approximately 26 months
    10% deterioration in QOL: up to approximately 25 months
    QTc interval: baseline, cycle 1 day 15, cycle 2 day 1 and cycle 3 day 1
    Supervivencia global: aprox. 69 meses
    TRG: aprox 25 meses
    Estado funcional del ECOG: aprox 25.5 meses
    Seguridad y tolerabilidad: up to approximately 26 months
    10% deterioro en QOL: aprox 25 meses
    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 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) 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) Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    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
    Austria
    Belgium
    Brazil
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Lebanon
    Mexico
    Netherlands
    Norway
    Russian Federation
    Singapore
    Slovakia
    South Africa
    Spain
    Sweden
    Taiwan
    Thailand
    Turkey
    United Kingdom
    United States
    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
    The end of the study is defined as when the patient permanently discontinues treatment with LEE011 + letrozole or placebo + letrozole and all the end of trial procedures are completed.
    El fin del estudio se define cuanto un paciente discontinua permanentmente el tratamiento con LEE011 + letrozol o placebo + letrozol y todos los procedimientos del fin del estudio han sido completados.
    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 months11
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days8
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 323
    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 continuing to derive benefit from study treatment at the end of the study in the opinion of the investigator will be able to continue receiving trial therapy on a separate protocol. Alternatively Novartis will provide study treatment to the investigator as per local regulations.
    Los pacientes que se sigan beneficiando del tratamiento al final del estudio en opinión de los investigadores podrán seguir recibiendo el tratamiento del estudio en un protocolo a parte. Novartis proporcionará el tratamiento del estudio a los investigadores según la regulación local.
    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 Decision2014-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-04
    P. End of Trial
    P.End of Trial StatusOngoing
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