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    Summary
    EudraCT Number:2016-005119-42
    Sponsor's Protocol Code Number:MO39193
    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:2017-12-21
    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 number2016-005119-42
    A.3Full title of the trial
    A PHASE III, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF ATEZOLIZUMAB PLUS CHEMOTHERAPY FOR PATIENTS WITH EARLY RELAPSING RECURRENT (INOPERABLE LOCALLY ADVANCED OR METASTATIC) TRIPLE-NEGATIVE BREAST CANCER
    ESTUDIO DE FASE III MULTICÉNTRICO, DOBLE CIEGO, RANDOMIZADO, CONTROLADO CON PLACEBO PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE ATEZOLIZUMAB MÁS QUIMIOTERAPIA EN PACIENTES CON CÁNCER DE MAMA TRIPLE NEGATIVO RECURRENTE (LOCALMENTE AVANZADO O METASTÁSICO INOPERABLE) CON RECIDIVA PRECOZ
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients with Early Relapsing Recurrent Triple-Negative Breast Cancer
    Un Estudio de la Eficacia y Seguridad de Atezolizumab más Quimioterapia para Pacientes con Recaída Recurrente Triple-Negativo de Cáncer de Mama
    A.4.1Sponsor's protocol code numberMO39193
    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. ( Soc.Unipersonal) que realiza el ensayo en España y que actua como representante de Hoffmann-La Roche.
    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 number913257300
    B.5.6E-mailspain.start_up_unit@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 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 nameatezolizumab
    D.3.2Product code RO5541267
    D.3.4Pharmaceutical form 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 INNATEZOLIZUMAB
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 No
    D.IMP: 2
    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 Carbosin
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharma Belgium AG
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameCarboplatin
    D.3.4Pharmaceutical form 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 INNcarboplatin
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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: 3
    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 Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameCapecitabine
    D.3.2Product code RO 0091978
    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 INNCAPECITABINE
    D.3.9.2Current sponsor codeRo 009-1978/J12-00
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCAPECITABINE
    D.3.9.2Current sponsor codeRo009-1978/J13-00
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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: 4
    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 Gitrabin 200mg
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC ehf
    D.2.1.2Country which granted the Marketing AuthorisationRomania
    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 nameGemcitabine
    D.3.4Pharmaceutical form Powder 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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number38
    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: 5
    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 Gitrabin 1000mg
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC ehf
    D.2.1.2Country which granted the Marketing AuthorisationRomania
    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 nameGemcitabine
    D.3.4Pharmaceutical form Powder 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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number38
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Triple-Negative Breast Cancer (TNBC)
    Cáncer de mama triple negativo (CMTN)
    E.1.1.1Medical condition in easily understood language
    TNBC refers to a type of breast cancer that does not express the genes for estrogen receptor (ER), progesterone receptor (PgR) or HER2/neu
    CMTN se refiere a un tipo de cáncer de mama que no expresa los genes de receptor de estrógeno (ER), receptor de progesterona (PgR) o HER2 / neu
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10075566
    E.1.2Term Triple negative 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
    • To evaluate the efficacy of atezolizumab plus chemotherapy compared to placebo plus chemotherapy based on overall survival
    Evaluar la eficacia de atezolizumab más quimioterapia en comparación con placebo más quimioterapia basada en la supervivencia global
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of atezolizumab plus chemotherapy compared to placebo plus chemotherapy based on survival rate, progression free survival, objective response rate, duration of objective response, clinical benefit rate
    • To evaluate patient-reported outcomes (PROs) of global health status (GHS)/health-related quality of life (HRQoL) associated with atezolizumab plus chemotherapy compared with chemotherapy alone, as measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
    • To evaluate the safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy
    • To characterize the pharmacokinetics (PK) of atezolizumab when administered with carboplatin/gemcitabine or with capecitabine in patients with breast cancer
    • To evaluate the immunogenicity of atezolizumab
    • To assess the efficacy and safety of atezolizumab plus chemotherapy according to programmed death−ligand 1 (PD-L1) status
    Evaluar eficacia de atezolizumab más quimioterapia en comparación con placebo más quimioterapia basada en la tasa de supervivencia, supervivencia libre de progresión, tasa de respuesta objetiva, duración de la respuesta objetiva, tasa de beneficio clínico. Evaluar los resultados reportados por los pacientes(PRO) correspondientes al estado salud general (ESG)/calidad de vida relacionada con la salud (CVRS), asociados con atezolizumab más quimioterapia comparado con quimioterapia sola, basándose en el cuestionario de calidad de vida Questionnaire Core 30 (EORTC QLQ-C30)Evaluar seguridad de atezolizumab más quimioterapia en comparación con placebo más quimioterapia, Caracterizar la farmacocinética (PK) de atezolizumab cuando se administra con carboplatino / gemcitabina o con capecitabina en pacientes con cáncer de mama, Evaluar la inmunogenicidad del atezolizumab, Evaluar la eficacia y seguridad de atezolizumab más quimioterapia según el estado programado de muerte-ligando 1 (PD-L1)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female >= 18 years of age
    - Histologically confirmed TNBC that is either locally recurrent, inoperable and cannot be treated with curative intent or is metastatic
    - Documented disease progression occurring within 12 months (<12 months) from the last treatment with curative intent
    - Have not received prior chemotherapy or targeted systemic therapy for their locally advanced inoperable or metastatic recurrence
    - Measurable or non-measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
    - Availability of a representative formalin-fixed paraffin-embedded (FFPE) tumour block (preferred) or at least 25 unstained slides with an associated pathology report, if available
    - Eastern Cooperative Oncology Group performance status 0-1
    - Life expectancy >= 12 weeks
    - Adequate haematologic and end-organ function, Negative human immunodeficiency virus (HIV) test at screening
    - Negative hepatitis B surface antigen (HBsAg) test at screening
    - Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
    - Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
    - The HCV RNA test will be performed only for patients who have a positive HCV antibody test
    - Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of <=1% per year during the treatment period and for at least 5 months after the last dose of study treatment
    - Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm, with female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of carboplatin/gemcitabine to avoid exposing the embryo.
    -Varones o mujeres >= 18 años de edad
    -Presentar CMTN confirmado histológicamente, con recurrencia local o metastásica inoperable y que no pueda ser tratado con intención curativa
    -Progresión de la enfermedad documentada (p. ej. Con muestra de biopsia, informe histopatológico o radiológico) producida en los <12 meses siguientes al último tratamiento con intención curativa
    -No haber recibido previamente quimioterapia o tratamiento sistémico dirigido para la enfermedad recurrente localmente avanzada o metastásica inoperable
    -Presentar enfermedad medible o no medible, definida de acuerdo con los criterios RECIST 1.1
    -Disponibilidad de un bloque de tejido tumoral representativo, fijado en formalina e incluido en parafina (FFPE) (opción preferida), o de un mínimo de 25 laminillas no teñidas junto con el correspondiente informe histopatológico, si está disponible.
    -Estado funcional del Eastern Cooperative Oncology Group (ECOG) 0-1.
    -Esperanza de vida ≥ 12 semanas.
    -Función hematológica y de órganos diana adecuada,Prueba del Virus de la Inmunodeficiencia Humana (VIH) negativa en el período de selección.
    -Prueba del antígeno de superficie de la hepatitis B (HBsAg) negativa en el período de selección.
    -Resultado negativo para el anticuerpo contra el antígeno del núcleo del virus de la hepatitis B (HBcAb) en el periodo de selección, o resultado positivo en la prueba de HBcAb seguido de un resultado negativo en la prueba del ácido desoxirribonucleico (ADN) del virus de la hepatitis B (VHB) en el periodo de selección.
    -Resultado negativo en el análisis del anticuerpo contra el virus de la hepatitis C (VHC) o positivo para el anticuerpo contra VHC, seguido de un resultado negativo en la prueba del ácido ribonucleico (ARN) del VHC, en el período de selección.
    -La prueba de ARN de VHC se realizará únicamente en los pacientes que sean positivos para el anticuerpo contra VHC.
    -Las mujeres potencialmente fértiles deben comprometerse a practicar la abstinencia sexual (es decir, abstenerse de mantener relaciones heterosexuales) o a usar un método anticonceptivo con una tasa de fracaso ≤1% al año, durante el período de tratamiento y como mínimo hasta 5 meses después de la administración de la última dosis del tratamiento del estudio.
    -Los varones deben comprometerse a practicar la abstinencia sexual (es decir, abstenerse de mantener relaciones heterosexuales) o a usar métodos anticonceptivos, así como a no donar semen.Los varones con pareja femenina potencialmente fértil o embarazada deben comprometerse a practicar la abstinencia sexual o a usar preservativos durante el período de tratamiento y como mínimo, hasta 6 meses después de la administración de la última dosis de carboplatino/gemcitabina, para evitar la exposición del embrión
    E.4Principal exclusion criteria
    - Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomisation
    - Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
    - Symptomatic or rapid visceral progression
    - No prior treatment with an anthracycline and taxane
    - History of leptomeningeal disease
    - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
    - Uncontrolled tumour-related pain
    - Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
    - Malignancies other than TNBC within 5 years prior to randomisation, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate  90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localised prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer)
    - Significant cardiovascular disease
    - Presence of an abnormal ECG that is clinically significant in the investigator’s opinion
    - Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomisation, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia
    - Current treatment with anti-viral therapy for HBV
    - Major surgical procedure within 4 weeks prior to randomisation or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis
    - Treatment with investigational therapy within 28 days prior to randomisation
    - Pregnant or lactating, or intending to become pregnant during or within 5 months after the last dose of study treatment
    - Compresión de médula espinal no tratada de forma definitiva con cirugía y/o radioterapia o diagnosticada y tratada previamente, sin evidencia de estabilización clínica de la enfermedad durante > 2 semanas antes de la randomización.
    - Metástasis del sistema nervioso central (SNC) sintomáticas, no tratadas o progresivas.
    metastases
    - Progresion visceral sintomatica o rapida
    -No tratamiento previo con antraciclina o taxano
    - Antecedentes de enfermedad leptomeníngea
    - Derrame pleural, pericárdico o ascitis no controlados que requieran procedimientos de drenaje recurrente.
    - Dolor relacionado con el tumor, no controlado.
    - Hipercalcemia no controlada o sintomática o hipercalcemia sintomática que requiera el uso continuado de bifosfonatos.
    -Neoplasias malignas distintas de CMTN en los 5 años previos a la randomización, exceptuando aquellas que tengan un riesgo insignificante de metástasis o muerte (p. ej. tasa de SG a 5 años >90%) y hayan sido tratadas con intención curativa con el resultado esperado (tales como carcinoma in situ de cérvix, carcinoma de piel distinto de melanoma, cáncer de próstata localizado, carcinoma ductal in situ o cáncer de útero en estadio I tratados adecuadamente)
    - Enfermedades cardiovasculares significativas,
    - Presencia de anomalías en el ECG que sean clínicamente significativas de acuerdo con la opinión del investigador.
    - Infecciones graves que han requerido antibióticos por vía oral o IV en las 4 semanas previas a la randomización, incluyendo aunque no exclusivamente, infecciones complicadas que requieran hospitalización, bacteremia o neumonía grave.
    - Tratamiento actual con terapia antiviral para el VHB.
    -Procedimientos de cirugía mayor que no sean con fines diagnósticos en las 4 semanas previas a la randomización o que previsiblemente sean necesarios en el transcurso del estudio.
    -Tratamiento con un agente en investigación en los 28 días previos a la randomización.
    - Mujeres embarazadas o en período de lactancia o que tengan intención de quedarse embarazadas durante el estudio o en los 5 meses siguientes a la administración de la última dosis del tratamiento del estudio
    E.5 End points
    E.5.1Primary end point(s)
    1. Overall survival
    1. Supervivencia general
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to 30 months
    1. Hasta 30 meses
    E.5.2Secondary end point(s)
    1. 12-month survival rate
    2. 18-month survival rate
    3. Progression-free survival
    4. Objective response rate
    5. Duration of objective response
    6. Clinical benefit rate
    7. Time to deterioration (TTD) of GHS/HRQoL
    8. Incidence, nature and severity of adverse events (AEs), with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0)
    9. Change from baseline in targeted vital signs and physical findings
    10. Change from baseline in targeted clinical laboratory test results
    11. Maximum and minimum observed serum concentration (Cmax and Cmin) of atezolizumab
    12. Incidence of anti-drug antibodies (ADAs) during the study relative to the prevalence of ADAs at baseline.
    13. Relationship between PD-L1 protein expression by immunohistochemistry (Ventana® SP142 assay) in screening tumour tissue and clinical outcomes
    1. Tasa de supervivencia a 12 meses
    2. Tasa de supervivencia a 18 meses
    3. Supervivencia libre de progresión
    4. Tasa de respuesta objetiva
    5. Duración de la respuesta objetiva
    6. Tasa de beneficios clínicos
    7. Tiempo hasta el deterioro (TD) de la ESG/CVRS
    8.Incidencia, tipo y gravedad (determinada de acuerdo con los Criterios de Terminología Común para Acontecimientos Adversos del National Cancer Institute, Versión 4.0 [NCI CTCAE v4.0]) de los acontecimientos adversos (AA)
    9.Cambio producido respecto al valor basal en las constantes vitales y los hallazgos de la exploración física específicos
    10. Cambio respecto al valor basal en los resultados de las pruebas de laboratorio clínico específicas
    11. Concentración sérica máxima y mínima observada (Cmax y Cmin) de atezolizumab
    12.Incidencia de anticuerpos contra el fármaco (ADA) durante el estudio, en relación con su prevalencia en el período basal.
    13. Relación entre la expresión de la proteína PD-L1 evaluada mediante inmunohistoquímica (ensayo SP142 de Ventana®) en muestras de tejido tumoral obtenidas y los resultados clínicos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Month 12
    2. Month 18
    3-13. Up to 36 months
    1. Mes 12
    2. Mes 18
    3-Hasta 36 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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity and biomarker objectives
    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 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Algeria
    Bosnia and Herzegovina
    Brazil
    Cuba
    Egypt
    France
    Germany
    Hong Kong
    Hungary
    Italy
    Kazakhstan
    Korea, Republic of
    Mexico
    Morocco
    Panama
    Russian Federation
    Serbia
    Singapore
    South Africa
    Spain
    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 the last patient last visit (LPLV).
    El final del estudio se define como la última visita del ultimo paciente (LPLV).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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: 292
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 58
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 350
    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)
    The Sponsor will offer continued access to Sponsor study drug (atezolizumab) free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, as outlined in section 4.3.5 of the protocol.
    El Promotor ofrecera acceso continuado al farmaco del estudio (Atezolizumab) gratis a los pacientes elegibles de acuerdo con la politica global de Roche de acceso continuado a farmacos en investigacion tal y como se refleja en la sección 4.3.5 del protocolo
    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 Decision2017-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-26
    P. End of Trial
    P.End of Trial StatusOngoing
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