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    Summary
    EudraCT Number:2014-001237-83
    Sponsor's Protocol Code Number:BO29389
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-19
    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 number2014-001237-83
    A.3Full title of the trial
    A PHASE II, MULTICENTER, SINGLE-ARM STUDY OF TRASTUZUMAB EMTANSINE IN PATIENTS WITH HER2 IHC-POSITIVE, LOCALLY ADVANCED OR METASTATIC NON?SMALL CELL LUNG CANCER WHO HAVE RECEIVED AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN
    ENSAYO CLINICO FASE IIA, MULTICENTRICO, DE UN UNICO BRAZO, DE TRASTUZUMAB EMTANSINA EN PACIENTES CON CARCINOMA NO MICROCITICO DE PULMON LOCALMENTE AVANZADO O METASTASICO HER-2 POSITIVO, QUE HAN RECIBIDO AL MENOS UN REGIMEN PREVIO DE QUIMIOTERAPIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Kadcyla study in patients with HER2-positive lung cancer after chemotherapy treatment
    Estudio de Kadcyla en pacientes con cancer de Pulmón HER-2 Positivo, tras tratamiento de quimioterapia.
    A.4.1Sponsor's protocol code numberBO29389
    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 SponsorRoche Farma, S.A en nombre de F. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34913257300
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 Kadcyla
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City AL7 1TW, UK
    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 nametrastuzumab emtansine (T-DM1)
    D.3.2Product code RO530-4020/F02-01
    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 emtansine
    D.3.9.1CAS number 1018448-65-1
    D.3.9.2Current sponsor codeRO5304020
    D.3.9.3Other descriptive nameTrastuzumab emtansine
    D.3.9.4EV Substance CodeSUB35467
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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) 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 Yes
    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 typeAntibody-drug conjugate comprised of a humanized monoclonal antibody (trastuzumab) and DM1.
    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 IHC-Positive (IHC 2 + or IHC 3 +), Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
    HER2 IHC Positiva ( IHC 2+ or IHC 3 +), cáncer no microcítico de pulmón localmente avanzado o metastásico.
    E.1.1.1Medical condition in easily understood language
    Lung Cancer, HER2-positive
    Cáncer de Pulmón, HER2- Positive
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung 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
    To evaluate the efficacy of single-agent trastuzumab emtansine in patients with centrally confirmed HER2-IHC positive (IHC 2 + or IHC 3 +) locally advanced or metastatic NSCLC who have received at least one prior chemotherapy regimen, as measured by confirmed ORR based on investigator assessment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (see Appendix 3).
    Evaluar la eficacia del trastuzumab emtansina, como fármaco único, en pacientes diagnosticados de cáncer no microcítico de pulmón localmente avanzado o metastasico, positivo mediante inmunohistoquímica (IHC 2+ o 3+) para el receptor del factor de crecimiento epidérmico 2 (HER2), confirmado de forma centralizada, que han recibido por lo menos un régimen de quimioterapia, determinada mediante la tasa de respuesta global (TRG), de acuerdo con la evaluación del investigador, según los criterios de evaluación de la respuesta en tumores sólidos, versión 1.1 (RECIST v1.1).
    E.2.2Secondary objectives of the trial
    The secondary efficacy objectives for this study are as follows:
    ? To evaluate PFS, duration of response (DoR), and clinical benefit rate (CBR) according to RECIST v1.1 (see Appendix 3), based on investigator assessment
    ? To evaluate OS

    The safety objective for this study is to evaluate the safety and tolerability of trastuzumab emtansine administered Q3W as a single agent to patients with HER2 IHC positive (IHC 2 + or IHC 3 +) NSCLC.

    The pharmacokinetic (PK) objective for this study is to characterize the pharmacokinetics of trastuzumab emtansine and assess the anti-therapeutic antibody (ATA) responses to trastuzumab emtansine in patients with HER2 IHC-positive locally advanced or metastatic NSCLC.
    Evaluar la supervivencia libre de progresión (SLP), la duración de la respuesta (DR) y la tasa de beneficio clínico (TBC) según RECIST v1.1, de acuerdo con la evaluación del investigador.
    Evaluar la supervivencia global (SG).

    El objetivo de seguridad de este estudio es evaluar la seguridad y la tolerabilidad del trastuzumab emtansina, administrado cada 3 semanas, como fármaco único, a pacientes que padecen cáncer no microcítico de pulmón, positivo para HER2 IHC (IHC 2 + o IHC 3 +).

    El objetivo farmacocinético de este estudio es caracterizar la farmacocinética del trastuzumab emtansina y evaluar las respuestas de anticuerpos antiterapéuticos (AAT), al trastuzumab emtansina, en pacientes que padecen cáncer no microcítico de pulmón, positivo para HER2 mediante inmunohistoquímica, localmente avanzado o metastásico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >/= 18 years
    - Histologically or cytologically documented diagnosis of Stage IIIB not amenable to radical treatment or Stage IV NSCLC; pathological characterization must determine the non-squamous or squamous histological subtype as well as adenocarcinoma subtype classification.
    - HER2 status of IHC 2+ or 3+ as determined by a Sponsor-designated central laboratory
    - Prior treatment with at least one regimen of platinum-based (cisplatin or carboplatin) chemotherapy in the locally advanced or metastatic setting/recurrent NSCLC with documented disease progression by investigator assessment
    - Patients with a known ALK fusion oncogene (must be documented in the patient's chart) must have also experienced disease progression or intolerance with a first-line ALK Tyrosine Kinase Inhibitor (TKI) approved for the treatment of ALK fusion oncogene NSCLC (e.g., crizotinib). Disease progression or intolerance must be documented
    - Patients with a known mutation in the EGFR gene (must be documented in the patient's chart) must have also experienced disease progression or intolerance with an EGFR TKI approved for the treatment of EGFR-mutant NSCLC (e.g., gefitinib, erlotinib, afatinib). Disease progression or intolerance must be documented.
    - Measurable disease determined as per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1
    - Life expectancy >/= 12 weeks
    - Adequate organ function
    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    - LVEF >/= 50% by either echocardiogram (ECHO) or or multiple-gated acquisition (MUGA)
    - Use of highly effective contraception
    - Edad ? 18 años.
    - Diagnóstico documentado mediante histología o citología, de cáncer no microcítico de pulmón, estadio IIIB, no susceptible de tratamiento radical, o estadio IV. La caracterización anatomopatológica debe determinar el subtipo histológico no epidermoide o epidermoide, así como la clasificación de subtipo de adenocarcinoma.
    -Estado HER2 de IHC 2 + o 3 +, determinado por el laboratorio central designado por el Promotor.
    -Tratamiento anterior por lo menos con un regimen de quimioterapia basada en platino (cisplatino o carboplatino) para el cáncer no microcítico de pulmón, localmente avanzado o metastásico, o recurrente, con constancia de la progresión de la enfermedad por la evaluación del investigador.
    - Los pacientes con oncogén de fusión ALK comprobado (debe constar en la historia clínica del paciente) también deben haber sufrido la progresión de la enfermedad o intolerancia con un ITK ALK de primera línea para el tratamiento del cáncer no microcítico de pulmón con oncogén de fusión ALK (p. ej., crizotinib). La Progresión de la enfermedad o intolerancia, se debe documentar.
    - Los pacientes con mutación comprobada del gen del receptor del factor de crecimiento epidérmico (EGFR) (debe constar en la historia clínica del paciente) también deben haber sufrido la progresión de la enfermedad o intolerancia con un ITK EGFR aprobado para el tratamiento del cáncer no microcítico de pulmón con mutación de EGFR (p. ej., gefitinib, erlotinib, afatinib). La Progresión de la enfermedad o intolerancia, se debe documentar.
    -Enfermedad medible, determinada mediante RECIST v1.1.
    -Esperanza de vida ? 12 semanas.
    - Función adecuada de los órganos.
    - Estado funcional ECOG 0 o 1.
    - Fracción de eyección del ventrículo izquierdo (FEVI) ? 50%, determinada mediante ecocardiografía o MUGA.
    - Uso de anticonceptivos altamente efectivos.
    E.4Principal exclusion criteria
    Cancer-Related Criteria
    - Any approved anti-cancer therapy </= 21 days (including chemotherapy or hormonal therapy) before the first study treatment; the following exceptions are allowed: (1) TKIs approved for the treatment of NSCLC must be discontinued > 7 days prior to the first study treatment on Cycle 1, Day 1 (The baseline computed tomography scan must be completed after discontinuation of TKIs); (2) Hormone-replacement therapy or oral contraceptives; (3) Anti-emetics, GCS-F, prophylactic antibiotics are allowed according to local standards
    - Investigational therapy participation in another clinical study with therapeutic intent </= 21 days before first study treatment
    - Previous irradiation is permitted if >/= 14 days since the last fraction of radiotherapy have elapsed before the first study treatment on Day 1 of Cycle 1 as long as a sufficient number of target lesions remain to allow for measurable disease as per RECIST v1.1.
    - Patients who have untreated brain metastases or are symptomatic; patients with treated brain metastases must have discontinued corticosteroid therapy and not have any neurological symptoms
    - History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any excipient of the product
    - History of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin > 500 mg/m2; Epirubicin > 900 mg/m2; Mitoxantrone > 120 mg/m2. If another anthracycline, or more than one anthracycline, has been used, the cumulative dose must not exceed the equivalent of 500 mg/m2 doxorubicin.
    - Current peripheral neuropathy of Grade >/= 3 per the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v. 4.0
    - History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those mentioned above.

    Cardiopulmonary Function Criteria
    - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
    - Severe dyspnea at rest due to complications of advanced malignancy or requiring current continuous oxygen therapy
    - Clinical history of active hemoptysis
    - Evidence of active pneumonitis during screening
    - Current unstable ventricular arrhythmia requiring treatment
    - History of symptomatic congestive heart failure (CHF; New York Heart Association [NYHA] Classes II-IV)
    - History of myocardial infarction or unstable angina within 6 months of enrollment
    - History of a decrease in LVEF to < 50%

    General Criteria
    - Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
    - Major surgical procedure or significant traumatic injury within 28 days before enrollment or anticipation of the need for major surgery during the course of study treatment
    - Current pregnancy or lactation
    - Current known active infection with HIV, hepatitis B, or hepatitis C virus
    Criterios relacionados con el cáncer
    - Cualquier tratamiento aprobado para el cáncer, ? 21 días (incluso la quimioterapia y la hormonoterapia) antes del primer tratamiento del estudio. Están permitidas las siguientes excepciones:
    Debe interrumpirse la administración de los ITK aprobado para el tratamiento del cáncer no microcítico del pulmón > 7 días antes del primer tratamiento del estudio en el 1er día del 1er ciclo. (La TAC inicial debe completarse después de interrumpir la administración de ITK),Hormonoterapia sustitutiva o anticonceptivos orales, Están permitidos los antieméticos, GCS-F, los antibióticos profilácticos, según las normas locales.
    - Participación en otro estudio clínico con tratamiento investigacional con intención terapéutica ? 21 días antes del primer tratamiento del estudio.
    - Está permitida la irradiación anterior si han transcurrido ? 14 días desde la última dosis de radioterapia antes del primer tratamiento del estudio en el 1er día del 1er ciclo, mientras permanezca una cantidad suficiente de lesiones destinatarias para tener en cuenta la enfermedad medible, según RECIST v1.1
    - Pacientes con metástasis encefálicas no tratadas o que están sintomáticos; Los pacientes con metástasis encefálicas tratadas deben haber suspendido la corticoterapia y no deben presentar síntomas neurológicos.
    - Antecedentes de intolerancia (incluso reacción a la infusión, de grado 3 o 4) o hipersensibilidad al trastuzumab o a las proteínas murinas o a cualquier excipiente del producto.
    - Antecedentes de exposición a las siguientes dosis acumuladas de antraciclinas:doxorrubicina o doxorrubicina liposómica > 500 mg/m2;
    epirrubicina > 900 mg/m2;
    mitoxantrona > 120 mg/m2;
    Si se ha usado otra antraciclina o más de una antraciclina, la dosis acumulada no debe ser superior al equivalente de 500 mg/m2 de doxorrubicina.
    - Neuropatía periférica de grado ? 3, según los criterios comunes de terminología del National Cancer Institute para acontecimientos adversos, versión 4.0 (NCI CTCAE v4.0).
    - Antecedentes de otra neoplasia maligna en los cinco años anteriores, salvo por un carcinoma in situ del cuello uterino, carcinoma cutáneo que no sea melanoma, cáncer uterino de estadio I, tratado adecuadamente, u otros tipos de cáncer con un desenlace parecido a los mencionados más arriba.

    Criterios funcionales cardiopulmonares
    - Derrame pleural, derrame pericárdico o ascitis no controlados, que precisan colocaciones recurrentes de drenaje.
    - Disnea intensa en reposo a causa de complicaciones de neoplasia maligna avanzada o que precisa oxigenoterapia continua.
    - Antecedentes patológicos de hemoptisis activa.
    - Pruebas de neumonitis activa durante la selección.
    - Arritmia ventricular inestable actual que precisa tratamiento.
    - Antecedentes de insuficiencia cardíaca congestiva (clases II a IV de la New York Heart Association).
    - Antecedentes de infarto de miocardio o de angina inestable en los seis meses anteriores a la inscripción en el estudio.
    -Antecedentes de una disminución hasta el < 50% de la FEVI.

    Criterios generales
    - Patología sistémica grave, no controlada, actualmente (p. ej., enfermedad cardiovascular, pulmonar o metabólica, clínicamente importante).
    -Intervención quirúrgica mayor o lesión traumática considerable en los 28 días anteriores a la inclusión o previsión de la necesidad de una intervención quirúrgica mayor durante el tratamiento del estudio.
    - Embarazo o lactancia actual.
    -Infección activa comprobada actualmente por el VIH, el virus de la hepatitis B (VHB) o el virus de la hepatitis C (VHC).
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate, defined as a complete response (CR) or partial response (PR) determined on two consecutive assessments >/= 4 weeks apart and based on investigator assessment according to RECIST v. 1.1
    La respuesta objetiva se define como la RC o la RP determinada en dos evaluaciones consecutivas, con ? 4 semanas de separación. de acuerdo con la evaluación del investigador, según RECIST v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After three post-baseline tumor assessments (approximately 4.5 months) after last patient is enrolled
    El análisis se llevará a cabo en el momento en que se prevea que a todos los pacientes inscritos se les haya hecho tres evaluaciones del tumor después del inicio, lo que es aproximadamente 4,5 meses después de la inclusión del último paciente.
    E.5.2Secondary end point(s)
    - Progression-free survival (PFS), defined as the time from first study drug administration to first documented disease progression, by investigator assessment using RECIST v1.1
    - Duration of response (DOR), defined as the time from the initial documentation of objective response (CR or PR) to documented disease progression, using RECIST v1.1, or death from any cause
    - Serum concentrations of trastuzumab emtansine and total trastuzumab
    - Plasma concentration of DM1
    - Incidence of adverse events (AEs)
    - Overall survival (OS)
    - La supervivencia libre de progresión (SLP), definida como el tiempo desde la primera administración del medicamento del estudio hasta la primera progresión comprobada de la enfermedad (por la evaluación del investigador según RECIST v1.1
    - La duración de la respuesta, definida como el tiempo desde la constatación inicial por escrito de la respuesta (respuesta completa [RC] o respuesta parcial [RP] según RECIST v1.1) hasta la progresión constatada por escrito de la enfermedad según RECIST v1.1 o muerte por cualquier causa durante el estudio).
    - Las concentraciones plasmáticas de trastuzumab emtansina y de trastuzumab total.
    - Concentración Plasmática de DM1.
    - La incidencia de acontecimientos adversos( AEs)
    - La supervivencia global ( SG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - For progression-free survival (PFS): From first study drug administration to disease progression or death from any cause or study termination
    - For duration of response (DOR): From first documented objective response to disease progression or death from any cause or study termination
    - For serum concentrations of trastuzumab emtansine and total trastuzumab: Cycle 1 Day 1 and Cycle 3 Day 1; study treatment discontinuation or early termination visit
    - For plasma concentration of DM1: Cycle 1 Day 1 and Cycle 3 Day 1
    - For incidence of adverse events (AEs): From first study drug administration to death from any cause or study termination
    - For overall survival (OS): From first study drug administration to death from any cause or study termination
    SLP: desde 1ª administración del medicamento hasta progresión de enfermedad/muerte por cualquier causa/ terminación del estudio.Duración de la respuesta: desde constatación inicial por escrito de respuesta (RC o RP según RECIST v1.1) hasta progresión constatada por escrito de enfermedad según RECIST v1.1/ muerte por cualquier causa durante el estudio. Concentraciones plasmáticas de trastuzumab emtansina y trastuzumab total: Ciclo 1 Dia 1, Ciclo3 dia 1; interrupción tratamiento/visita de finalización anticipada.Concentración Plasmática DM1: Ciclo 1 Dia 1, Ciclo 3 Día1 .-Incidencia de AEs: desde la 1ª administración del medicamento hasta muerte por cualquier causa/terminación del estudio.SG: desde la 1ª administración del medicamento hasta muerte por cualquier causa/terminación 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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    European Union
    Korea, Republic of
    Switzerland
    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
    The end of study is defined when all enrolled patients discontinue the study treatment as described in protocol section 4.6.2. Survival data will be collect every 3 months after treatment discontinuation until death or end of study.
    El final del estudio se define cuando todos los pacientes incluidos abandonan el tratamiento del estudio. Se recogerán datos de supervivencia cada tres meses después de la interrupción del tratamiento, hasta el fallecimiento o el final del estudio.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 19
    F.4.2.2In the whole clinical trial 40
    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)
    Currently, the Sponsor does not have any plans to provide trastuzumab emtansine or other study interventions to patients after the conclusion of the study or any earlier patient withdrawal. The Sponsor will evaluate the appropriateness of continuing to provide trastuzumab emtansine to study patients after evaluating the primary efficacy outcome measure and safety data recorded in the study; these analyses may be conducted prior to completion of the study.
    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 Decision2014-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-26
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