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    Summary
    EudraCT Number:2016-003695-47
    Sponsor's Protocol Code Number:WO39391
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-28
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-003695-47
    A.3Full title of the trial
    A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY COMPARING ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY)
    IN COMBINATION WITH ADJUVANT ANTHRACYCLINE/TAXANEBASED CHEMOTHERAPY VERSUS CHEMOTHERAPY ALONE IN PATIENTS WITH OPERABLE TRIPLE-NEGATIVE BREAST CANCER
    STUDIO DI FASE III, MULTICENTRICO, RANDOMIZZATO, IN APERTO DI CONFRONTO TRA ATEZOLIZUMAB (ANTICORPO ANTI-PD-L1) IN COMBINAZIONE CON CHEMIOTERAPIA ADIUVANTE BASATA SU ANTRACICLINA/TAXANO E CHEMIOTERAPIA DA SOLA IN PAZIENTI CON CANCRO DELLA MAMMELLA TRIPLO NEGATIVO OPERABILE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Compare Atezolizumab (Anti-PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple-Negative Breast Cancer
    Studio per confrontare Atezolizumab (anticorpo anti PD-L1) in combinazione con chemioterapia adiuvante basata su antraciclina/taxano e chemioterapia da sola in pazienti con cancro della mammella triplo operabile
    A.3.2Name or abbreviated title of the trial where available
    A Study to Compare Atezolizumab (Anti-PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Tax
    Uno studio per confrontare Atezolizumab (Anti-PD-L1 Antibody) in combinazione con chemioterapia basa
    A.4.1Sponsor's protocol code numberWO39391
    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 SponsorF. 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/ cityBasilea
    B.5.3.3Post code 4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041616881111
    B.5.5Fax number0041616919319
    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 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/F03
    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.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codeRO5541267
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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 Paclitaxel
    D.2.1.1.2Name of the Marketing Authorisation holderActavis S.R.L.
    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 namePaclitaxel
    D.3.2Product code [RO024-7506]
    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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0 to 1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Doxorubicin
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC
    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 nameDoxorubicin
    D.3.2Product code [Ro 020-3296]
    D.3.4Pharmaceutical form Solution for injection
    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 INNDOXORUBICIN HYDROCHLORIDE
    D.3.9.1CAS number 23214-92-8
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB01827MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Cyclophosphamide
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Oncology GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namecyclophosphamide
    D.3.2Product code [Ro 004-2106]
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    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 INNCYCLOPHOSPHAMIDE
    D.3.9.1CAS number 50-18-0
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB06859MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Epirubicin
    D.2.1.1.2Name of the Marketing Authorisation holderS.C Actavis S.R.L.
    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 nameEpirubicin
    D.3.2Product code [Ro 018-7742]
    D.3.4Pharmaceutical form Solution for injection
    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 INNepirubicin
    D.3.9.1CAS number 56390-09-1
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB01915MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 6
    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 Tecentriq
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Products GmbH
    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/F03]
    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 INNATEZOLIZUMAB
    D.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 No
    D.IMP: 7
    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/F05]
    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 INNATEZOLIZUMAB
    D.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A, Tecentriq
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 No
    D.IMP: 8
    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 DOXO-cell
    D.2.1.1.2Name of the Marketing Authorisation holderStadapharm GmBH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameDoxorubicin
    D.3.2Product code [Ro 020-3296]
    D.3.4Pharmaceutical form Solution for injection
    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 INNDOXORUBICINA CLORIDRATO
    D.3.9.1CAS number 23214-92-8
    D.3.9.2Current sponsor codeDOXORUBICIN
    D.3.9.4EV Substance CodeSUB01827MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 9
    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.2.1.1.2Name of the Marketing Authorisation holdergeneric SMPC
    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 nameDoxorubicin
    D.3.2Product code [Ro 020-3296]
    D.3.4Pharmaceutical form Solution for injection
    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 INNDOXORUBICINA CLORIDRATO
    D.3.9.1CAS number 23214-92-8
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB01827MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Triple-negative breast cancer (TNBC)
    Tumore alla mammella triplo negativo
    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
    Tumore alla mammella triplo negativo (TNBC): un tipo di tumore che non esprime i recettori per gli estrogeni (ER), per il progesterone (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 10006187
    E.1.2Term 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 adjuvant atezolizumab + paclitaxel, dose-dense doxorubicin/epirubicin, and cyclophosphamide (T-AC/EC) compared with T-AC/EC alone in patients with TNBC based on invasive disease-free survival (iDFS)
    Valutare l'efficacia di atezolizumab adiuvante +paclitaxel, dose-densa di doxorubicin/epirubicin, e ciclofosfamide (T-AC/EC) rispetto a T-AC/EC da solo nei pazienti con TNBC basato sulla soppravvivenza libera da malattia invasiva (iDFS)
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of adjuvant atezolizumab + T-AC/EC compared with T-AC/EC alone based on iDFS in the PD-L1 selected and in the node-positive disease subpopulations, overall survival (OS), recurrence-free interval (RFI), Distant RFI and disease-free survival (DFS)
    • To evaluate patient-reported outcomes (PROs) of function and health-related quality of life (HRQoL) associated with atezolizumab + T-AC/EC compared with T-AC/EC alone, as measured by the validated patient reported outcome tools
    • To evaluate the safety and tolerability of atezolizumab + T-AC/EC compared with T-AC/EC alone
    • To characterize the serum pharmacokinetics of atezolizumab when administered in combination with T-AC/ EC chemotherapy
    • To evaluate the immune response to atezolizumab
    •Valutare l'efficacia di atezolizumab adiuvante + T-AC/EC rispetto a T-AC/EC da solo basato su iDFS nelle sottopolazioni con stato del tumore selezionato in base all'espressione di PD-L1 e con positività linfonodale, sopravvivenza complessiva (OS), RFI definito come lasso di tempo libero da recidiva locale e distante (RFI), sopravvivenza libera da malattia (DFS)
    •Valutare gli esiti funzionali riferiti dai pazienti (PROs) e la qualità della vita (HRQoL) associati a atezolizumab +T-AC/EC rispetto al solo T-AC/EC, misurati tramite i questionari validati degli esiti riferiti dai pazienti
    •Valutare la sicurezza e la tollerabilità di atezolizumab +T-AC/EC rispetto al solo T-AC/EC
    •Caratterizzare la farmacocinetica sierica di atezolizumab quando viene somministrato in combinazione con la chemioterapia T-AC/EC
    •Valutare la risposta immunitaria ad atezolizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years
    - Eastern Cooperative Oncology Group Performance Status of 0 or 1
    - Non-metastatic operable Stage II-III breast cancer; patients with node-negative disease must have a pathologic tumor size > 2cm
    - Histologically documented TNBC that is centrally confirmed
    - Confirmed tumor Programmed death-ligand 1 (PD-L1) evaluation (centrally conducted)
    - Adequately excised: Patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
    - Pathological tumor-node-metastasis staging: Patient must have had sentinel lymph node biopsy and/or axillary lymph node dissection for evaluation of pathologic nodal status
    - Patients with synchronous bilateral invasive disease are eligible only if all bilateral invasive lesions are histologically confirmed as triple negative by central lab and have completed adequate pathological tumor-node metastasis staging bilaterally as described
    - No more than 8 weeks (56 days) may elapse between definitive breast surgery and randomization
    - Baseline left ventricular ejection fraction >= 53% measured by echocardiogram or multiple-gated acquisition scans
    - Adequate hematologic and end-organ function
    - Negative 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 total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
    - 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.
    - Representative formalin-fixed, paraffin embedded tumor specimen from surgical resection in paraffin blocks or at least 25 unstained slides, with an associated pathology report documenting locally assessed ER, PgR, and HER2 negativity.Patients with 20 to 25 unstained slides available at baseline may be eligible upon discussion with the Medical Monitor.
    - For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab, or 6 months after the last dose of paclitaxel or doxorubicin/epirubicin, or 12 months after the last dose of cyclophosphamide
    - For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm during the treatment period and 6 months after the last dose of paclitaxel, cyclophosphamide, or doxorubicin/epirubicin or 12 months after the last dose of cyclophosphamide whichever is later
    - Women who are not postmenopausal and have not undergone a sterilization procedure must have a negative serum pregnancy test result within 14 days prior to initiation of study drug
    -Età>=18 anni
    -Performance status secondo l'ECOG (Eastern Cooperative Oncology Group) 0 oppure 1
    -Cancro della mammella non metastatico operabile Stadio II-III; i pazienti con malattia con negatività linfonodale devono avere una dimensione del tumore all'esame di anatomia patologica > 2 cm
    -TNBC documentato all'esame istologico centralmente confermato
    -Valutazione PD-L1 di tumore confermato come documentato tramite analisi centralizzata
    -Adeguatamente escisso: i pazienti devono essere stati sottoposti a chirurgia conservativa della mammella o a mastectomia/mastectomia conservativa del capezzolo o della cute
    -Stadiazione patologica tumore-nodi-metastasi : il paziente deve essere stato sottoposto a biopsia dei linfonodi sentinella e/o a dissezione dei linfonodi ascellari per la valutazione dello stato patologico nodale.
    -I pazienti con malattia invasiva bilaterale sincrona sono idonei solo se tutte le lesioni invasive bilaterali sono confermate all'esame istologico come triple negative dal laboratorio centrale e hanno completato un'adeguata stadiazione patologica tumore-nodi-metastasi bilateralmente come descritto.
    -Tra l’intervento chirurgico definitivo della mammella e la randomizzazione non possono trascorrere più di 8 settimane (56 giorni).
    -Funzionalità ematologica e dell'organo adeguata
    -Test HIV negativo allo screening.
    -Test dell’antigene di superficie dell’epatite B (HBsAg) negativo allo screening.
    -Test degli anticorpi totali anti-core dell’epatite B (HBcAb) negativo allo screening o test HBcAb totali positivo seguito da un test del virus dell’epatite B (HBV) DNA negativo allo screening. Il test dell’HBV DNA sarà eseguito solo per pazienti con un test HBcAb totali positivo. -Test degli anticorpi per il virus dell’epatite C (HCV) negativo allo screening o test anticorpale HCV positivo seguito da un test HCV RNA negativo allo screening.Il test HCV RNA sarà eseguito solo per pazienti con un test anticorpale HCV positivo.
    -Campione tumorale rappresentativo fissato in formalina, incluso in paraffina proveniente da resezione chirurgica in blocchi di paraffina o almeno 25 vetrini non colorati, con associato un referto di anatomia patologica che documenta la negatività valutata localmente di ER, PgR, e HER2. I pazienti per i quali sono disponibili da 20 a 25 vetrini non colorati al basale potrebbero essere idonei previa discussione con il Monitor medico.
    -Per donne in età fertile: impegno a praticare l'astinenza o a usare metodi contraccettivi che presentano una percentuale di insuccesso < 1% l'anno durante il periodo di trattamento e per almeno 5 mesi dopo l'ultima dose di atezolizumab, o 6 mesi dopo l'ultima dose di paclitaxel o doxorubicina/epirubicina, o 12 mesi dopo l'ultima dose di ciclofosfamide
    -Per gli uomini: impegno a praticare l'astinenza o a utilizzare metodi di contraccezione e impegno ad astenersi dalla donazione di sperma, durante il periodo di trattamento e per almeno 6 mesi dopo l'ultima dose di paclitaxel, ciclofosfamide, o doxorubicina/epirubicina o 12 mesi dopo l'ultima dose di ciclofosfamide, a seconda di quale avvenga per ultima.
    -Le donne non in post-menopausa e che non si sono sottoposte a procedura di sterilizzazione, devono avere un risultato negativo al test di gravidanza sul siero nei 14 giorni precedenti all'inizio del farmaco dello studio.
    E.4Principal exclusion criteria
    - Prior history of invasive breast cancer
    - Any T4 clinical tumor
    - For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment planned in the context of this study
    - Previous therapy with anthracyclines or taxanes for any malignancy
    - History of ductal carcinoma in situ and/or lobular carcinoma in situ that was treated with any form of systemic, hormonal therapy, or radiotherapy (RT) to the ipsilateral breast where invasive cancer subsequently developed
    - Contraindication to RT when adjuvant RT is clinically indicated
    - Cardiopulmonary dysfunction
    - Prior malignancies within 5 years prior to randomization
    - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    - Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells
    - Known allergy or hypersensitivity to any component of the atezolizumab, paclitaxel, cyclophosphamide, or doxorubicin/epirubicin formulations and filgrastim or pegfilgrastim or granulocyte-macrophage colony-stimulating factor formulations and G-CSF ( or granulocyte-macrophage colony-stimulating factor) formulations
    - Active or history of autoimmune disease or immune deficiency
    - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
    - Current treatment with anti-viral therapy for HBV
    - Urinary outflow obstruction
    - Severe infections within 4 weeks prior to initiation of study treatment
    - Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
    - Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study treatment
    - Prior allogeneic stem cell or solid organ transplant
    - Administration of a live attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study or within 5 months after the last dose of atezolizumab
    - Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
    - Prior treatment with CD137 agonists or immune checkpoint-blockade therapies
    - Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during the study
    - Pregnant or lactating, or intending to become pregnant during the study
    -Anamnesi precedente di cancro della mammella invasivo
    -Qualsiasi tumore clinico T4
    -Per il cancro della mammella attualmente diagnosticato, qualsiasi precedente trattamento sistemico antitumorale previsto nel contesto di questo studio
    -Terapia precedente con antracicline o taxani per qualsiasi neoplasia maligna
    -Anamnesi di Carcinoma duttale in situ e/o Carcinoma in situ lobulare trattati con qualsiasi forma di terapia sistemica, ormonale o con RT nella mammella ipsilaterale dove si è sviluppato in seguito il cancro invasivo
    -Controindicazione alla RT quando la RT adiuvante è indicata clinicamente
    -Disfunzione cardiopolmonare
    -Neoplasie maligne precedenti nei 5 anni prima della randomizzazione
    -Anamnesi di gravi reazioni allergiche, anafilattiche o di ipersensibilità di altro tipo agli anticorpi chimerici o umanizzati o alle proteine di fusione
    -Ipersensibilità nota ai biofarmaci prodotti nelle cellule ovariche di criceto cinese
    -Allergia o ipersensibilità nota a qualsiasi componente della formulazione di atezolizumab, di paclitaxel, ciclofosfamide, o formulazioni di doxorubicina/epirubicina e formulazioni G-CSF (o fattore stimolante le colonie di granulociti-macrofagi)
    -Malattia autoimmune o immunodeficienza
    -Anamnesi di fibrosi polmonare idiopatica, polmonite in via di organizzazione, polmonite indotta da farmaci, polmonite idiopatica, oppure evidenza di polmonite attiva alla TAC del torace
    -Trattamento in corso con terapia antivirale per HBV
    -Ostruzione del deflusso urinario
    -Infezioni gravi nelle 4 settimane precedenti all'inizio del trattamento dello studio
    -Trattamento con terapia antibiotica orale o e.v. nelle 2 settimane precedenti all'inizio del
    trattamento dello studio
    -Intervento chirurgico importante non relativo alla diagnosi nelle 4 settimane precedenti all'inizio del trattamento dello studio o previsione di esigenza di intervento chirurgico importante durante il trattamento dello studio.
    -Trapianto allogenico precedente di cellule staminali o trapianto di organo solido
    -Somministrazione di vaccino vivo attenuato nelle 4 settimane prima dell'inizio del trattamento dello studio o previsione di esigenza di tale vaccino durante lo studio o entro 5 mesi dall'ultima dose di atezolizumab
    -Qualsiasi altra patologia, disfunzione metabolica, riscontro all'esame fisico o risultato clinico di laboratorio per i quali l'uso di un farmaco sperimentale è controindicato, possono influenzare l'interpretazione dei risultati o porre il paziente ad alto rischio di complicanze da trattamento
    -Trattamento precedente con agonisti CD137 o terapie di blocco del checkpoint immunitario
    -Trattamento con farmaci immunosoppressori sistemici nelle 2 settimane precedenti l'avvio del trattamento dello studio o in previsione dell'esigenza di farmaci immunosoppressori sistemici durante lo studio
    -Paziente gravida o in allattamento, o che pianifica una gravidanza durante lo studio
    E.5 End points
    E.5.1Primary end point(s)
    1. iDFS
    1. iDFS
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 7 years
    Sino a 7 anni
    E.5.2Secondary end point(s)
    1. iDFS in the subpopulation with PD-L1-selected tumor status (IC1/2/3) and node-positive disease 2. OS 3. iDFS including second primary non-breast invasive cancer as an event 4. RFI 5. Distant RFI 6. DFS 7. Occurrence and severity of adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 8. Mean and mean changes from baseline score in function (role, physical) and global health status (GHS)/HRQoL by assessment timepoint, and between treatment arms as assessed by the functional and GHS/HRQoL scales of the EORTC QLQ-C30 9. Serum concentration of atezolizumab at specified timepoints 10. Incidence of anti-drug antibodies (ADAs) during the study relative to the prevalence of ADAs at baseline
    1.iDFS nella sottopopolazione con stato del tumore selezionato in base all'espressione di PD-L1 (IC1/2/3)e con positività linfonodale 2. sopravvivenza complessiva 3. iDFS comprendente il secondo cancro primario invasivo non della mammella come evento 4. RFI 5. RFI distante 6.DFS 7. Presenza e gravità degli eventi avversi seri come definiti da NCI CTCAE v4.0 8. media e variazioni medie dal punteggio del basale nella funzione (ruolo, fisica) e nella GHS/HRQoL in base al punto temporale di valutazione, e tra i bracci di trattamento valutati in base alle scale funzionali e della GHS/HRQoL dell'EORTC QLQ-C30 9. concentrazione sierica di atezolizumab a tempi specifici 10. incidenza degli ADA durante lo studio relativo alla prevalenza degli ADA al basale
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-8. Up to 7 years 9-10. Day 1 of Cycle 1-4, 6, 10, and 15 and at treatment discontinuation visit (<= 30 days after last dose) and at 120 days after last dose of atezolizumab
    1-8 Sino a 7 anni. 9-10 Giorno 1 del ciclo 1-4, 6, 10 e 15 e alla visita di interruzione del trattamento (<= giorni dopo l'ultima dose) e a 120 giorni dopo l'ultima dose atezolizumab
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Paclitaxel, Doxorubicina/Epirubicina, Ciclofosfamide
    Paclitaxel, Doxorubicin/Epirubicin, Cyclophosphamide
    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 concerned25
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA130
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Brazil
    China
    Costa Rica
    Czechia
    Denmark
    France
    Germany
    Guatemala
    Hong Kong
    Hungary
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Poland
    Romania
    Russian Federation
    Singapore
    Spain
    Switzerland
    Taiwan
    Thailand
    Ukraine
    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 study is planned to end when approximately 289 deaths have been observed for the analysis of OS.
    Si è pianificato che lo studio finirà quando saranno stati osservati circa 289 decessi per l'analisi della sopravvivenza complessiva (OS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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: 1150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1150
    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 state99
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 950
    F.4.2.2In the whole clinical trial 2300
    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)
    When appropriate, the Sponsor will offer access to atezolizumab to patients still benefiting from the treatment at the end of the study in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product. http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    Se del caso, lo sponsor offrirà l'accesso a atezolizumab ai pazienti che beneficiano ancora del trattamento alla fine dello studio in conformità con la politica globale di Roche sul continuo accesso al medicinale in fase di sperimentazione.
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    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 Decision2018-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-23
    P. End of Trial
    P.End of Trial StatusOngoing
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