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    Summary
    EudraCT Number:2010-019577-16
    Sponsor's Protocol Code Number:EGF114299
    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:2011-11-25
    Trial results View 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 number2010-019577-16
    A.3Full title of the trial
    A Phase III trial to compare the safety and efficacy of lapatinib plus trastuzumab plus an aromatase inhibitor (AI) versus trastuzumab plus an AI versus lapatinib plus an AI as first-line therapy in postmenopausal subjects with hormone receptor positive, HER2-positive metastatic breast cancer (MBC) who have received trastuzumab and endocrine therapy in the neoadjuvant and/or adjuvant setting
    Ensayo de fase III para comparar la seguridad y la eficacia de lapatinib más trastuzumab más un inhibidor de la aromatasa (IA) frente a trastuzumab más un IA y frente a lapatinib más un IA como tratamiento de primera línea en pacientes posmenopáusicas con cáncer de mama metastásico (CMM) HER2 positivo y receptor hormonal positivo que han recibido trastuzumab y tratamiento endocrino en el contexto neoadyuvante y/o adyuvante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib or trastuzumab, or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer
    Un estudio para comparar la seguridad y la eficacia de un inhibidor de la aromatasa en combinación con lapatinib o trastuzumab o con ambos para el tratamiento del cáncer de mama metastásico HER2 positivo y receptor hormonal positivo.
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberEGF114299
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01160211
    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 SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointGSK Clinical Support Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressGlaxoSmithKline, Iron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 020 8 9904466
    B.5.5Fax number+44 020 8 9904968
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 Tyverb
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameLapatinib
    D.3.2Product code GW572016
    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 INNLapatinib
    D.3.9.1CAS number 388082-78-8
    D.3.9.2Current sponsor codeGW572016
    D.3.9.3Other descriptive nameLAPATINIB DITOSILATO MONOHIDRATO
    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.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.2.1.1.1Trade name Herceptin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameTrastuzumab
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo monoclonal IgG humanizado.
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HER2-positive metastatic breast cancer who have received trastuzumab and endocrine therapy in the neoadjuvant and/or adjuvant setting
    Cáncer de mama metastásico (CMM) HER2 positivo que han recibido trastuzumab y tratamiento endocrino en el contexto neoadyuvante y/o adyuvante
    E.1.1.1Medical condition in easily understood language
    Advanced/Metastatic Breast Cancer
    Cáncer de mama metastásico/avanzado
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10065430
    E.1.2Term HER-2 positive breast cancer
    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
    The primary objective is to demonstrate superiority of lapatinib/trastuzumab/AI combination (Treatment Group A) vs. trastuzumab/AI combination (Treatment Group B) for overall survival.
    Demostrar la superioridad de la combinación lapatinib/trastuzumab/inhibidor de la aromatasa (IA) (tratamiento del Grupo A) frente a la combinación trastuzumab/IA (tratamiento del Grupo B) en cuanto a supervivencia global (SG).
    E.2.2Secondary objectives of the trial
    - To compare OS in Treatment Group B (trastuzumab/AI) vs. Treatment Group C (lapatinib/AI) and Treatment Group A (trastuzumab/lapatinib/AI) vs. Treatment Group C (lapatinib/AI)
    - To compare progression free survival (PFS) in Treatment Group A (lapatinib/trastuzumab/AI) vs. Treatment Group B (trastuzumab/AI) and Treatment Group C ( lapatinib/AI) vs. Treatment Group B (trastuzumab/AI)
    - To compare overall response rate (complete or partial response), time to response, and duration of response in Treatment Group A (lapatinib/trastuzumab/AI) vs. Treatment Group B (trastuzumab/AI) and Treatment Group C (lapatinib/AI) vs. Treatment Group B (trastuzumab/AI)
    - To compare clinical benefit (complete response, partial response, or stable disease for at least 6 months) in Treatment Group A (lapatinib/trastuzumab/AI) vs. Treatment Group B (trastuzumab/AI) and Treatment Group C (lapatinib/AI) vs. Treatment Group B (trastuzumab/AI)
    Comparar:
    - la SG con trastuzumab/IA frente a lapatinib/IA y con trastuzumab/lapatinib/IA frente a lapatinib/IA.
    - la SSP con lapatinib/trastuzumab/IA frente a trastuzumab/IA y con lapatinib/IA frente a trastuzumab/IA.
    - la tasa de respuesta global (respuesta completa o parcial), el tiempo hasta la respuesta y la duración de la respuesta con lapatinib/trastuzumab/IA frente a trastuzumab/IA y con lapatinib/IA frente a trastuzumab/IA.
    - los efectos clínicos beneficiosos (respuesta completa, respuesta parcial o enfermedad estable durante al menos 6 meses) con lapatinib/trastuzumab/IA frente a trastuzumab/IA y con lapatinib/IA frente a trastuzumab/IA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Refer to the authorized prescribing information for lapatinib [TYKERB Package Insert, 2010], trastuzumab [HERCEPTIN Package Insert, 2009], letrozole [FEMARA Package Insert, 2010], anastrozole [ARIMIDEX Package Insert, 2009], and exemestane [AROMASIN Package Insert, 2008] for specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the study treatment(s) that may impact subject eligibility.

    Subjects eligible for enrollment in the study must meet all of the following criteria:
    1. Signed written informed consent
    2. Post-menopausal female subjects >= 18 years of age. Post-menopausal as defined by any of the following:
    - Age > 60 years
    - Age > or 45 years with amenorrhea > 12 months with an intact uterus
    - Having undergone a bilateral oophorectomy or radiation castration with amenorrhea for at least 6 months
    - FSH and estradiol levels in postmenopausal range (utilizing ranges from the local laboratory facility). In subjects who have previously been treated with an GnRH/LHRH analogue, the last injection must have been administered >4 months prior to randomization and menses must not have restarted
    3. Histologically confirmed Stage IV invasive breast cancer
    - Subjects may have either measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [Eisenhauer, 2009]
    4. Tumors that are ER+ and/or PgR+ by local laboratory
    5. Documentation of HER2 overexpression or gene amplification, in the invasive component of either the primary tumor or metastatic disease site as defined as:
    - 3+ by Immunohistochemistry (IHC)
    and/or
    - HER2/neu gene amplification by fluorescence, chromogenic or silver in situ hybridization [FISH, CISH or SISH; >6 HER2/neu gene copies per nucleus or a FISH, CISH or SISH test ratio (HER2 gene copies to chromosome 17 signals) of >= 2.0]
    6. Subject must have received prior neoadjuvant and/or adjuvant trastuzumab
    7. Subject must have received prior neoadjuvant and/or adjuvant endocrine therapy
    8. Subjects who have a life expectancy of > 6 months as assessed by the treating investigator
    9. Have baseline of Left Ventricular Ejection Fraction (LVEF) >= 50% measured by echocardiography (ECHO) or multi-gated acquisition scan (MUGA)
    10. ECOG performance status of 0-1 (Section 12.2, Appendix 2)
    11. All prior treatment related toxicities must be CTCAE (Version 4.0) <= Grade 1 [NCI, 2009] at the time of randomization
    12. Completion of screening assessments
    13. Adequate baseline organ function defined by: (Refer to page 26 of Protocol)
    French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
    Consúltese la información de prescripción autorizada en relación con lapatinib [ficha técnica de TYKERB, 2010], trastuzumab [ficha técnica de HERCEPTIN, 2009], letrozol [ficha técnica de FEMARA, 2010], anastrozol [ficha técnica de ARIMIDEX, 2009] y exemestano [ficha técnica de AROMASIN, 2008] para obtener información específica sobre advertencias, precauciones, contraindicaciones, acontecimientos adversos y otros tipos de información pertinente sobre el tratamiento del estudio que podrían influir en la elegibilidad de las pacientes.

    Podrán participar en el estudio las pacientes que cumplan todos los criterios siguientes:
    1. Consentimiento informado por escrito firmado.
    2. Mujeres posmenopáusicas >= 18 años. Se define 'posmenopáusica' como cualquiera de las situaciones siguientes:
    - Edad > 60 años.
    - Edad >= 45 años con amenorrea > 12 meses y útero intacto.
    - Haberse sometido a una ovariectomía bilateral o a castración mediante radiación con amenorrea durante al menos 6 meses.
    - Concentraciones de FSH y estradiol dentro del intervalo posmenopáusico (utilizando los intervalos del laboratorio local). En las pacientes que hayan recibido tratamiento previo con un análogo de la GnRH/LHRH, la última inyección debe haberse administrado > 4 meses antes de la aleatorización y no debe haber reaparecido la menstruación.
    3. Cáncer de mama invasivo en estadio IV confirmado histológicamente.
    - Las pacientes pueden tener enfermedad medible o no medible según los Criterios de evaluación de la respuesta en tumores sólidos (RECIST 1.1) [Eisenhauer, 2009].
    4. Tumores que son RE+ o RPg+ según el laboratorio local.
    5. Documentación de la sobreexpresión de HER2 o la amplificación de su gen en el componente invasivo del tumor primario o el foco de enfermedad metastásica definida como:
    - 3+ según la inmunohistoquímica (IHQ).
    y/o
    - Amplificación del gen HER2/neu mediante hibridación in situ con fluorescencia, cromógena o en plata [FISH, CISH o SISH; > 6 copias del gen HER2/neu por núcleo o un cociente entre las pruebas de FISH, CISH o SISH (copias del gen HER2 respecto a señales en el cromosoma 17) >= 2,0].
    6. Las pacientes deben haber recibido tratamiento previo con trastuzumab en el contexto neoadyuvante o adyuvante.
    7. Las pacientes deben haber recibido tratamiento endocrino previo en el contexto neoadyuvante o adyuvante.
    8. Pacientes con una esperanza de vida > 6 meses según el criterio del médico encargado de su tratamiento.
    9. Fracción de eyección del ventrículo izquierdo (FEVI) basal >= 50 % determinada mediante ecocardiograma (ECO) o ventriculografía isotópica en equilibrio (MUGA).
    10. Estado funcional del ECOG de 0 -1 (sección 12.2, apéndice 2).
    11. Toda la toxicidad relacionada con el tratamiento previo debe ser de un grado < = 1 según los CTCAE (versión 4.0) [NCI, 2009] en el momento de la aleatorización.
    12. Finalización de las evaluaciones de selección.
    13. Función orgánica adecuada en el momento basal, definida por (véase la página 24 del protocolo)
    Pacientes francesas: en Francia, sólo podrá incluirse en este estudio a pacientes afiliadas o beneficiarias de algún régimen de la seguridad social.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria must not be enrolled in the study:
    1. History of another malignancy.
    Exception: Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
    2. Subjects with extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or the disease is considered by the investigator to be rapidly progressing or life threatening (subjects who are intended for chemotherapy)
    3. Subjects who received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or anti-HER2 therapy for advanced or metastatic disease
    4. Serious cardiac illness or medical condition including but not confined to:
    - Uncontrolled arrhythmias
    - Uncontrolled or symptomatic angina
    - History of congestive heart failure (CHF)
    - Documented myocardial infarction <6 months from study entry
    5. Known history of, or clinical evidence of, central nervous system (CNS) metastases or leptomeningeal carcinomatosis
    6. Current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
    7. Concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject?s safety (for example, active or uncontrolled infection or any psychiatric condition prohibiting understanding or rendering of informed consent)
    8. Have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
    9. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to any of the study agents or their excipients that, in the opinion of the Investigator or GSK medical monitor, contraindicates their participation
    10. Any prohibited medication as described in Section 6.2 of the protocol.
    11. Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment.
    No deberá incluirse en el estudio a las pacientes que cumplan alguno de los criterios
    siguientes:
    1. Antecedentes de otras neoplasias malignas.
    Excepción: podrán participar las pacientes que hayan permanecido sin enfermedad durante 5 años y las que tengan antecedentes de un cáncer de piel distinto del melanoma totalmente resecado o de un carcinoma in situ tratado satisfactoriamente.
    2. Pacientes con afectación visceral extensa y sintomática, como la afectación hepática y la diseminación pulmonar linfangítica del tumor, o enfermedad que en opinión del investigador sea rápidamente progresiva o potencialmente mortal (pacientes a las que se ha propuesto quimioterapia).
    3. Pacientes que hayan recibido quimioterapia, tratamiento hormonal, inmunoterapia, tratamiento biológico o tratamiento anti-HER2 previo para la enfermedad avanzada o metastásica.
    4. Cardiopatía grave, incluyendo pero no limitado a:
    - Arritmias no controladas.
    - Angina de pecho no controlada o sintomática.
    - Antecedentes de insuficiencia cardíaca congestiva (ICC).
    - Infarto de miocardio documentado < 6 meses antes de la entrada en el estudio.
    5. Antecedentes conocidos o signos clínicos de metástasis en el sistema nervioso central (SNC) o carcinomatosis leptomeníngea.
    6. Enfermedad hepática o biliar activa actualmente (salvo pacientes con síndrome de Gilbert, litiasis biliar asintomática, metástasis hepáticas o hepatopatía crónica estable según la evaluación del investigador).
    7. Enfermedades concomitantes que puedan interferir en la participación en el estudio o cualquier trastorno médico grave que pueda interferir en la seguridad de las pacientes (por ejemplo, infección activa o no controlada o cualquier trastorno psiquiátrico que impida la comprensión o la concesión del consentimiento informado).
    8. Presencia de anomalías digestivas con importancia clínica que puedan alterar la absorción, como síndrome de malabsorción o resección importante del estómago o intestino.
    9. Presencia de reacción de hipersensibilidad inmediata o diferida o idiosincrasia a fármacos relacionados químicamente con los fármacos del estudio o sus excipientes que, en opinión del investigador o del monitor médico de GSK, contraindique la participación.
    10. Cualquier medicación prohibida tal como se describe en la sección 6.2.
    11. Administración de un fármaco en investigación en los 30 días o el período correspondiente a 5 semividas, lo que suponga más tiempo, anteriores a la primera dosis del tratamiento del estudio
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this study is overall survival assessed for lapatinib/trastuzumab/AI combination (Treatment Group A) vs. trastuzumab/AI combination (Treatment Group B). Overall Survival is defined as the time from randomization until death due to any cause.
    El criterio de valoración principal evaluará la SG en el grupo de tratamiento A (lapatinib/trastuzumab/IA) en comparación con el grupo de tratamiento B (trastuzumab/IA). La SG se define como el tiempo transcurrido desde la aleatorización hasta la muerte por cualquier causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time point of primary end point, overall survival will be assessed at
    the end of study - Q2 2018
    El tiempo de la variable principal, la supervivencia global se valorará al final del estudio - 2º trimestre de 2018
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints of this study are:
    - OS in Treatment Group B (trastuzumab/AI) vs. Treatment Group C (lapatinib/AI) and Treatment Group A (trastuzumab/lapatinib/AI) vs. Treatment Group C (lapatinib/AI) defined as the time from randomization until death due to any cause.
    - Progression free survival (PFS) in Treatment Group A (lapatinib/trastuzumab/AI) vs. Treatment Group B (trastuzumab/AI) and Treatment Group C (lapatinib/AI) vs. Treatment Group B (trastuzumab/AI) which is defined as the interval of time (in weeks) between the date of randomization and the earlier of date of disease progression or date of death due to any cause as assessed by the investigator.
    - Overall response rate (complete or partial response) which is defined as the percentage of subjects achieving either a CR or PR as per RECIST 1.1 criteria in Treatment Group A (lapatinib/trastuzumab/AI) vs. Treatment Group B (trastuzumab/AI) and Treatment Group C (lapatinib/AI) vs. Treatment Group B (trastuzumab/AI) as assessed by the investigator.
    - Time to response which is defined as the time from randomization until first documented evidence of PR or CR (whichever status is recorded first) as per RECIST 1.1 criteria in Treatment Group A (lapatinib/trastuzumab/AI) vs. Treatment Group B (trastuzumab/AI) and Treatment Group C (lapatinib/AI) vs. Treatment Group B (trastuzumab/AI) as assessed by the investigator.
    - Duration of response which is defined, for the subset of subjects who achieve a CR or PR, to be the time from first documented evidence of PR or CR until the first documented sign of disease progression or death due to breast cancer, if sooner as per RECIST 1.1 criteria in Treatment Group A (lapatinib/trastuzumab/AI) vs. Treatment Group B (trastuzumab/AI) and Treatment Group C (lapatinib/AI) vs. Treatment Group B (trastuzumab/AI) as assessed by the investigator.
    - Clinical benefit in Treatment Group A (lapatinib/trastuzumab/AI) vs. Treatment Group B (trastuzumab/AI) and Treatment Group C (lapatinib/AI) vs. Treatment Group B (trastuzumab/AI) which is defined as the percentage of subjects with evidence of CR, PR, or SD for at least 6 months as per RECIST 1.1 criteria as assessed by the investigator.
    Los criterios secundarios de valoración de la eficacia de este estudio son:
    - SG en el grupo de tratamiento B (trastuzumab/IA) frente al grupo de tratamiento C (lapatinib/IA) y en el grupo de tratamiento A (trastuzumab/lapatinib/IA) frente al grupo de tratamiento C (lapatinib/IA), definida como el tiempo transcurrido desde la aleatorización hasta la muerte por cualquier causa.
    - Supervivencia sin progresión (SSP) en el grupo de tratamiento A (lapatinib/trastuzumab/IA) frente al grupo de tratamiento B (trastuzumab/IA) y en el grupo de tratamiento C (lapatinib/IA) frente al grupo de tratamiento B (trastuzumab/IA), definida como el intervalo de tiempo transcurrido (en semanas) entre la fecha de aleatorización y la fecha de progresión de la enfermedad o la fecha de la muerte por cualquier causa, lo que suceda primero, según el criterio del investigador.
    - Tasa de respuesta global (respuesta completa o parcial), definida como el porcentaje de pacientes que logren una RC o RP con arreglo a los criterios RECIST 1.1 en el grupo de tratamiento A (lapatinib/trastuzumab/IA) frente al grupo de tratamiento B (trastuzumab/IA) y en el grupo de tratamiento C (lapatinib/IA) frente al grupo de tratamiento B (trastuzumab/IA) según el criterio del investigador.
    - Tiempo hasta la respuesta, definido como el tiempo transcurrido desde la aleatorización hasta la primera prueba documentada de RC o RP (la que se registre antes) con arreglo a los criterios RECIST 1.1 en el grupo de tratamiento A (lapatinib/trastuzumab/IA) frente al grupo de tratamiento B (trastuzumab/IA) y en el grupo de tratamiento C (lapatinib/IA) frente al grupo de tratamiento B (trastuzumab/IA) según el criterio del investigador.
    - Duración de la respuesta, definida, para el subgrupo de pacientes que logren una RC o RP, como el tiempo transcurrido desde la primera prueba documentada de RP o RC hasta el primer signo documentado de progresión de la enfermedad o la muerte por cáncer de mama, en caso de ser anterior, con arreglo a los criterios RECIST 1.1 en el grupo de tratamiento A (lapatinib/trastuzumab/IA) frente al grupo de tratamiento B (trastuzumab/IA) y en el grupo de tratamiento C (lapatinib/IA) frente al grupo de tratamiento B (trastuzumab/IA) según el criterio del investigador.
    - Efectos clínicos beneficiosos en el grupo del tratamiento A (lapatinib/trastuzumab/IA) frente al grupo de tratamiento B (trastuzumab/IA) y en el grupo de tratamiento C (lapatinib/IA) frente al grupo de tratamiento B (trastuzumab/IA), definidos como el porcentaje de pacientes que presenten pruebas de RC, RP o EE durante al menos 6 meses con arreglo a los criterios RECIST 1.1 según el criterio del investigador.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The time point of the secondary end points: overall survival and progression free survival will be assessed at the end of study - Q2 2018. Lesion assessments assessed by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) will be performed every 12 weeks and at study conclusion.
    El tiempo de los criterios secundarios de valoración: supervivencia global y supervivencia libre de progresión se valorará al final del estudio - 2º trimestre 2018. Las evaluaciones de las lesiones se determinarán con arreglo a los Criterios de evaluación de la respuesta en
    tumores sólidos (RECIST 1.1) cada 12 semanas y 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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 No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA124
    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
    Belgium
    Brazil
    Bulgaria
    Croatia
    Germany
    Hong Kong
    Hungary
    India
    Ireland
    Korea, Republic of
    Lithuania
    Norway
    Poland
    Portugal
    Romania
    Russian Federation
    Taiwan
    Ukraine
    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
    Collection of all study data will continue until: at least 75% of subjects have reached an event (death) or at most 25% subjects are censored AND the last subject has discontinued study treatment. The primary endpoint is Overall survival so when the events for the analysis have been reached that will be the final analysis
    La recogida de los datos del estudio continuará hasta que: al menos el 75% de los pacientes haya alcanzado un acontecimiento (muerte) o un máximo del 25% de los sujetos sean censurados Y el último sujeto haya discontinuado el tratamiento del estudio. La variable principal es la supervivencia global, por lo que en el momento que los acontecimientos para el análisis se hayan alcanzado ese será el análisis final.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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: 340
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 185
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 263
    F.4.2.2In the whole clinical trial 525
    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)
    Post study treatment will not be provided by GSK as part of this protocol. Upon discontinuation from an assigned study treatment, subjects may receive additional anticancer therapy at the discretion of the treating physician. The investigator is responsible for ensuring that consideration has been given for the post-study care of the patient's medical condition.
    El tratamiento después del estudio no lo proprocionará GSK como parte de este protocolo. Una vez que se discontinue de un tratamiento del estudio asignado, las pacientes pueden recibir tratamiento contra el cáncer adicional según decida el médico. El investigador es responsable de asegurar que se haya dado la consideración para el cuidado de la enfermedad del paciente después del estudio.
    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 Decision2012-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-07
    P. End of Trial
    P.End of Trial StatusOngoing
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