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    The EU Clinical Trials Register currently displays   38520   clinical trials with a EudraCT protocol, of which   6330   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-002930-22
    Sponsor's Protocol Code Number:IOM-050371
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-11-22
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-002930-22
    A.3Full title of the trial
    A randomized, open-label, multicenter, two-arm, phase III study to evaluate efficacy and quality of life in patients with metastatic hormone receptor-positive HER2-negative breast cancer receiving ribociclib in combination with endocrine therapy or chemotherapy with or without bevacizumab in first line
    Randomisierte, offene, zwei-armige Phase III Studie zur Untersuchung der Wirksamkeit und der Lebensqualität von Patientinnen mit metastasiertem HER2-negativem, Hormonrezeptor-positivem Brustkrebs unter Erstlinienbehandlung mit endokriner Therapie in Kombination mit Ribociclib oder Chemotherapie mit / ohne Bevacizumab.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate efficacy and quality of life in postmenopausal patients with metastatic hormone receptor-positive HER2-negative breast cancer receiving ribociclib in combination with endocrine therapy or chemotherapy with or without bevacizumab in first line
    Klinische Studie zur Untersuchung der Wirksamkeit und der Lebensqualität von postmenopausalen Patientinnen mit metastasiertem HER2-negativem, Hormonrezeptor-positivem Brustkrebs unter Erstlinienbehandlung mit endokriner Therapie in Kombination mit Ribociclib oder Chemotherapie mit / ohne Bevacizumab.
    A.3.2Name or abbreviated title of the trial where available
    RIBBIT
    A.4.1Sponsor's protocol code numberIOM-050371
    A.5.4Other Identifiers
    Name:Study code NovartisNumber:CLEE011ADE04T
    Name:AIO codeNumber:AIO-MAM-0117/ass
    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 SponsoriOMEDICO AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationiOMEDICO AG
    B.5.2Functional name of contact pointDr. Beate Niemeier
    B.5.3 Address:
    B.5.3.1Street AddressEllen-Gottlieb-Straße 19
    B.5.3.2Town/ cityFreiburg
    B.5.3.3Post code79106
    B.5.3.4CountryGermany
    B.5.4Telephone number+49761152420
    B.5.5Fax number+497611524280
    B.5.6E-mailinfo@iomedico.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 Kisqali
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm 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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRIBOCICLIB
    D.3.9.1CAS number 1211441-98-3
    D.3.9.4EV Substance CodeSUB180246
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country 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.3.4Pharmaceutical form 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.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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: 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.2.1.2Country 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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEXEMESTANE
    D.3.9.1CAS number 107868-30-4
    D.3.9.4EV Substance CodeSUB07492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.2.1.2Country 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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNANASTROZOLE
    D.3.9.1CAS number 120511-73-1
    D.3.9.4EV Substance CodeSUB05502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.2.1.2Country 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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLETROZOLE
    D.3.9.1CAS number 112809-51-5
    D.3.9.4EV Substance CodeSUB08444MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 6
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country 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.3.4Pharmaceutical form 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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country 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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCapecitabine
    D.3.9.1CAS number 154361-50-9
    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.3.9.1CAS number 154361-50-9
    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 number300
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCapecitabine
    D.3.9.1CAS number 154361-50-9
    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: 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.2.1.2Country 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.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFulvestrant
    D.3.9.1CAS number 129453-61-8
    D.3.9.3Other descriptive nameFULVESTRANT
    D.3.9.4EV Substance CodeSUB13933MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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.2.1.2Country 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.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGOSERELIN
    D.3.9.1CAS number 65807-02-5
    D.3.9.4EV Substance CodeSUB07962MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.6
    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: 10
    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.2.1.2Country 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.3.4Pharmaceutical form Prolonged-release suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEUPRORELIN ACETATE
    D.3.9.1CAS number 74381-53-6
    D.3.9.4EV Substance CodeSUB02900MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.75
    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: 11
    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.2.1.2Country 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.3.4Pharmaceutical form Prolonged-release suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEUPRORELIN ACETATE
    D.3.9.1CAS number 74381-53-6
    D.3.9.4EV Substance CodeSUB02900MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11.25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The study will include adult women with HR-positive, HER2-negative advanced breast cancer with visceral metastases, who received no prior therapy for advanced disease.
    Diese Studie schließt erwachsene weibliche Patientinnen mit HR-positivem, HER2-negativem Brustkrebs mit viszeralen Metastasen ein, die keine vorangegangene Therapie in der fortgeschrittenen Situation erhalten haben.
    E.1.1.1Medical condition in easily understood language
    The study population includes patients with metastatic hormone receptor-positive HER2-negative breast cancer, who received no prior therapy for advanced disease.
    Die Studie umfasst Patientinnen mit metastasiertem HER2-negativem, Hormonrezeptor-pos. Brustkrebs, die keine vorangegangene Therapie in der fortgeschrittenen Situation erhalten haben.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057654
    E.1.2Term Breast cancer female
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10070577
    E.1.2Term Oestrogen receptor positive breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    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 compare the efficacy in terms of progression free survival (PFS) of ribociclib plus endocrine therapy with capecitabine with bevacizumab or paclitaxel with or without bevacizumab as first-line treatment of adult women with HR-positive, HER2-negative advanced breast cancer presenting with visceral metastasis.
    Vergleich der Wirksamkeit gemessen am progressionsfreien Überleben (PFS) der Kombination von Ribociclib mit einem Aromataseinhibitor (AI) / Fulvestrant gegen Capecitabin mit Bevacizumab oder Paclitaxel mit / ohne Bevacizumab als Erstlinientherapie des HR positiven, HER2 negativen Mammakarzinom mit viszeraler Metastasierung bei erwachsenen Patientinnen
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    - To assess and compare the two treatment arms with respect to the following efficacy outcomes: response rates, clinical benefit rate (CBR), time to response (TTR) and overall survival (OS).
    - To determine safety and tolerability in the two treatment arms in terms of (S)AEs, ECOG performance status, routine safety laboratory and electrocardiogram.
    - To evaluate and compare patient reported health-related QoL in terms of EORTC QLQ-C30 scores and single questions on burden by side effects and time spent on treatment in the two treatment arms.

    Exploratory objective:
    - To compare the two treatment arms with respect to sPFS.
    Sekundäre Studienziele:
    - Vergleich der beiden Studienarme hinsichtlich der folgenden Wirksamkeitsparameter: Ansprechraten (ORR), klinische Benefitrate (CBR), Zeit bis zum Ansprechen (TTR) und Gesamtüberleben (OS).
    - Bestimmung der Sicherheit und Verträglichkeit der beiden Behandlungsarme hinsichtlich der (S)UEs, ECOG Performance Status, Routinelaboruntersuchungen und Elektrokardiogramm.
    - Einschätzung und Vergleich der beiden Behandlungsarme in Bezug auf die gesundheitsbezogene Lebensqualität (QoL) mittels Auswertung des EORTC QLQ-C30 Fragebogen sowie weiterer Einzelfragen zur Belastung durch Nebenwirkungen der Therapie und Zeitaufwand für die Therapie

    Exploratives Studienziel:
    - Vergleich beider Therapiearme hinsichtlich des sPFS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Locally confirmed diagnosis of metastatic adenocarcinoma of the breast without prior systemic antineoplastic therapy in the palliative setting.
    • Hormone receptor (HR)-positive disease, defined as estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive.
    • Human epidermal growth factor receptor 2 (HER2)-negative disease (defined as IHC status HER2 negative/+ or IHC HER2++ with CISH/FISH negative).
    • Any menopausal status. If pre-/perimenopausal, agreement to receive LHRH (goserelin or leuprorelin) agonist / ovarian ablation in case of randomization to arm A.
    • Women with child bearing potential must agree to use an effective method of contraception while taking study medication and for the time-period indicated in the respective SmPC thereafter.
    • Presence of visceral metastases (additional non-visceral metastases are allowed).
    • Presence of target and / or non-target lesions according to RECIST v1.1
    • Patients eligible for palliative treatment with AI / fulvestrant + ribociclib and capecitabine + bevacizumab or paclitaxel + / - bevacizumab according to the respective SmPCs.
    • Signed written informed consent prior to beginning of protocol-specific procedures.
    • Frauen mit vor Ort bestätigter Diagnose eines metastasierten Adenokarzinom der Brust ohne vorangegangene systemische antineoplatische Therapie in der palliativen Situation.
    • Hormonrezeptor (HR)-positive Erkrankung, definiert als Östrogenrezeptor (ER)-positiv und / oder Progesteronrezeptor (PgR)-positiv.
    • Human epidermal growth factor receptor 2 (HER2)-negative Erkrankung, definiert als IHC-Status HER2 negativ/+ oder IHC HER2++ bei CISH/FISH negativem Befund.
    • Jeder Menopausenstatus. Bei Prä-/perimenopausalen Frauen Zustimmung zu einer Therapie mit einem LHRH-Agonisten (Goserelin oder Leuprorelin) oder einer Ovarektomie sofern sie in Arm A randomisiert werdenen.
    • Frauen im gebärfähigen Alter müssen zustimmen während der Studientherapie und im Anschluss für den in der Fachinformation angegebenen Zeitraum nach der letzten Dosis eine wirksame Verhütungsmethode anzuwenden.
    • Vorhandensein von viszeralen Metastasen (zusätzlich können weitere nicht-viszerale Metastasen vorhanden sein).
    • Vorliegen von Zielläsionen und / oder nicht-Zielläsionen gemäß RECIST v1.1.
    • Patienten müssen gemäß der entsprechenden Fachinformationen für eine palliative Therapie mit Ribociclib + AI /Fulvestrant und Capecitabin + Bevacizumab oder Paclitaxel +/- Bevacizumab qualifizieren.
    • Unterschriebene, schriftliche Einwilligung nach erfolgter Aufklärung vor Beginn von protokollspezifischen Maßnahmen.
    E.4Principal exclusion criteria
    • Any prior systemic palliative therapy
    • Prior treatment with any CDK4/6 inhibitor.
    • Prior adjuvant endocrine therapy if last intake within 12 months prior to entering the study
    • Prior adjuvant or neoadjuvant taxane, anthracycline or fluoropyrimidine therapy if last application within 12 months prior to entering the study.
    • Patient is concurrently using other anti-cancer therapy.
    • Patient has had major surgery within 28 days prior to randomization or has not recovered from major side effects or wound is not fully recovered.
    • Patient has received extended-field radiotherapy ≤ 4 weeks or limited-field radiotherapy ≤ 2 weeks prior to randomization.
    • Known hypersensitivity to ribociclib, AI, fulvestrant, paclitaxel, capecitabine, bevacizumab or any of their excipients, or against peanut, soya, CHO cell products or macrogolglycerol ricinoleate-35.
    • Participation in prior investigational studies within 30 days prior to randomization or within 5-half lives of the investigational product, whichever is longer.
    • Jegliche vorangegangene Palliativtherapie.
    • Vorangegangene Therapie mit irgendeinem CDK4/6 Inhibitor.
    • Vorangegangene endokrine adjuvante Therapie, wenn die letzte Einnahme weniger als 12 Monate vor Studieneinschluss zurückliegt.
    •Vorangegangene adjuvante oder neoadjuvante Therapie mit einem Taxan, Anthrazyklin oder Fluoropyrimidin, wenn die letzte Verabreichung innerhalb von 12 Monaten vor Studieneinschluss war.
    • Die Patientin erhält gleichzeitig eine andere anti-tumorale Therapie
    • Die Patientin hatte in den letzten 28 Tagen vor Randomisierung eine große Operation oder hat sich noch nicht von den bedeutenden Nebenwirkungen einer solchen erholt oder die Wunde ist noch nicht verheilt.
    • Die Patientin hat vor Randomisierung eine Bestrahlung erhalten (innerhalb von 4 Wochen eine extended-field Bestrahlung oder innerhalb von 2 Wochen eine limited-field Bestrahlung).
    • Bekannte Überempfindlichkeit gegen Ribociclib, AI, Fulvestrant, Capecitabin, Paclitaxel, Bevacizumab oder irgendeinen ihrer Inhaltsstoffe oder gegen Erdnuss, Soja, CHO-Zellprodukte oder Macrogolglycerolricinoleat.
    • Vorangegangene Teilnahme an einer klinischen Prüfung innerhalb von 30 Tagen oder 5 Halbwertszeiten des Prüfpräparats vor Randomisierung, je nach dem was länger ist.
    E.5 End points
    E.5.1Primary end point(s)
    PFS assessed by local investigator using RECIST v1.1 criteria. PFS is defined as time from randomization to progression of disease or death of any cause, whichever comes first. It will be assessed by imaging until progressive disease or start of next-line therapy.
    PFS beurteilt durch den lokalen Untersucher mittels RECIST v1.1 Kriterien. PFS ist definiert als Zeit von der Randomisierung bis zur Krankheitsprogression oder Tod jeglicher Ursache, je nach dem, was zuerst auftritt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Two interim and one final analysis will be performed.
    The first interim analysis (IA) will be performed once 30 patients per arm have been recruited and have been observed for 3 months. This IA will focus on descriptive analysis of the 3-month response rate. This analysis will also include baseline demographics and safety data (AEs).
    A second IA will be performed once 60 patients per arm have been recruited and have been observed for 3 months. This IA will provide a descriptive analysis of 3-month response rate and CBR. This analysis will also include baseline demographics and safety data (AEs).
    The final analysis will be performed after end of study and will provide data on all endpoints.
    Zwei Interims- und eine finale Analyse werden durchgeführt.
    Die erste Interimsanalyse (IA) wird durchgeführt nachdem 30 Patientinnen pro Arm rekrutiert und für 3 Monate beobachtet wurden. Der Fokus dieser IA liegt auf der deskriptiven Analyse der 3-Monats Ansprechrate. Die Analyse umfasst auch demographische Daten zu Baseline und Sicherheitsdaten (UEs).
    Eine zweite Interimsanalyse (IA) wird durchgeführt sobald 60 Patientinnen pro Arm rekrutiert und für 3 Monate beobachtet wurden. Diese IA umfasst eine deskriptive Analyse der 3-Monats Ansprechrate und der CBR. Die Analyse beinhaltet auch demographische Daten zu Baseline und Sicherheitsdaten (UEs).
    Die finale Analyse wird nach dem Ende der Studie durchgeführt und liefert Daten zu allen Endpunkten.
    E.5.2Secondary end point(s)
    Secondary endpoints:
    Efficacy:
    • ORR (complete or partial response) assessed by the local investigator according to RECIST v1.1.
    • CBR (complete or partial response or stable disease lasting 24 weeks or more) assessed by the local investigator according to RECIST v1.1.
    • TTR (time from randomization to first occurrence of any response (complete or partial)) assessed by the local investigator according to RECIST v1.1
    • OS, defined as time from randomization to death of any cause
    Safety and tolerability:
    • (S)AEs, frequency and severity graded according to CTCAE v4.03 until 30 days after EOT
    • Time to deterioration of ECOG performance status by at least one point
    • Routine safety laboratory until EOT
    • Electrocardiogram (QTc time) until EOT

    Patient-reported outcomes in QoL:
    • Time to decline of global health scale score of the EORTC QLQ C30 by at least 10 points
    • Change from baseline in the global health scale and all functional and symptom scores of the EORTC QLQ C30
    • Area under the curve in the global health scale and all functional and symptom scores of EORTC QLQ-C30 during study treatment from baseline to 24 weeks thereafter and from baseline to 1 year, 2 years and 3 years thereafter
    • Burden by side effects of treatment at all questionnaire time points (single item)
    • Burden by time spent on treatment at all questionnaire time points (four single item)
    Exploratory Endpoint:
    • sPFS, defined as time from randomization until symptomatic deterioration (new or worsening of persisting symptoms) or death as per local investigator
    Sekundäre Endpunkte:
    Wirksamkeit:
    • ORR (komplettes oder partielles Ansprechen) erfasst durch den lokalen Untersucher mittels RECIST v1.1.
    • CBR (komplettes oder partielles Ansprechen oder stabile Erkrankung für mindestens 24 Wochen) erfasst durch den lokalen Untersucher mittels RECIST v1.1.
    • TTR (Zeit von der Randomisierung bis zum ersten Ansprechen (komplett oder partiell)) erfasst durch den lokalen Untersucher mittels RECIST v1.1.
    • Gesamtüberleben definiert als Zeit von der Randomisierung bis zum Tod jeglicher Ursache.
    Sicherheit und Verträglichkeit:
    • (Schwerwiegende) Unerwünschte Ereignisse ((S)UE): Häufigkeit und Schweregrad gemäß CTCAE v4.03 bis 30 Tage nach Ende der Therapie
    • Zeit bis zur Verschlechterung des ECOG Performance Status um mindestens einen Punkt
    • Routinelaboruntersuchungen bis zum Therapieende
    • Elektrokardiogramm (EKG) bis zum Therapieende

    Vom Patienten berichtete Lebensqualität:
    • Zeit bis zur Abnahme des Wertes der Skala „globaler Gesundheitsstatus“ des EORTC QLQ C30 Fragebogens um mindestens 10 Punkte
    • Veränderung im Vergleich zur Baseline der Skala „globaler Gesundheitsstatus“ und aller funktionellen und Symptom –Skalen des EORTC QLQ C30
    • Fläche unter der Kurve der Skala „globaler Gesundheitsstatus“ und aller funktionellen und Symptom-Skalen des EORTC QLQ C30 unter Studienmedikation von Baseline bis Woche 24 und von Baseline bis 1, 2 und 3 Jahre danach
    • Belastung durch Nebenwirkungen der Therapie zu allen Fragebogenzeitpunkten (Einzelfrage)
    • Zeitliche Belastung durch die Therapie zu allen Fragebogenzeitpunkten (vier Einzelfragen)
    Explorativer Endpunkt:
    • sPFS, definiert als Zeit von der Randomisierung bis zur symptomatischen Verschlechterung (neue oder Verschlechterung bestehender Symptome) gemäß Beurteilung des lokalen Untersuchers oder Tod jeder Ursache
    E.5.2.1Timepoint(s) of evaluation of this end point
    Two interim and one final analysis will be performed.
    The first interim analysis (IA) will be performed once 30 patients per arm have been recruited and have been observed for 3 months. This IA will focus on descriptive analysis of the 3-month response rate. This analysis will also include baseline demographics and safety data (AEs).
    A second IA will be performed once 60 patients per arm have been recruited and have been observed for 3 months. This IA will provide a descriptive analysis of 3-month response rate and CBR. This analysis will also include baseline demographics and safety data (AEs).
    The final analysis will be performed after end of study and will provide data on all endpoints.
    Zwei Interims- und eine finale Analyse werden durchgeführt.
    Die erste Interimsanalyse (IA) wird durchgeführt nachdem 30 Patientinnen pro Arm rekrutiert und für 3 Monate beobachtet wurden. Der Fokus dieser IA liegt auf der deskriptiven Analyse der 3-Monats Ansprechrate. Die Analyse umfasst auch demographische Daten zu Baseline und Sicherheitsdaten (UEs).
    Eine zweite Interimsanalyse (IA) wird durchgeführt sobald 60 Patientinnen pro Arm rekrutiert und für 3 Monate beobachtet wurden. Diese IA umfasst eine deskriptive Analyse der 3-Monats Ansprechrate und der CBR. Die Analyse beinhaltet auch demographische Daten zu Baseline und Sicherheitsdaten (UEs).
    Die finale Analyse wird nach dem Ende der Studie durchgeführt und liefert Daten zu allen Endpunkten.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic 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) Yes
    E.8.2.2Placebo No
    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 concerned30
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days
    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: 79
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 79
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations 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 state158
    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)
    If patients discontinue study treatment (e.g. due to progression, toxicity or regular end of treatment) the investigator will offer appropriate treatment options according to current knowledge and treatment standards.
    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 Decision2018-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-14
    P. End of Trial
    P.End of Trial StatusOngoing
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