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    The EU Clinical Trials Register currently displays   42782   clinical trials with a EudraCT protocol, of which   7047   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-004482-89
    Sponsor's Protocol Code Number:GBG93
    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:2017-08-29
    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 number2016-004482-89
    A.3Full title of the trial
    A RANDOMIZED, OPEN-LABEL, MULTI-CENTER PHASE IV STUDY EVALUATING PALBOCICLIB PLUS ENDOCRINE TREATMENT VERSUS A CHEMOTHERAPY-BASED TREATMENT STRATEGY IN PATIENTS WITH HORMONE RECEPTOR POSITIVE / HER2 NEGATIVE METASTATIC BREAST CANCER IN A REAL WORLD SETTING.
    EINE RANDOMISIERTE, OFFENE, MULTIZENTRISCHE PHASE IV STUDIE ZUR EVALUIERUNG VON PALBOCICLIB UND ENDOKRINER THERAPIE IM VERGLEICH ZU EINER CHEMOTHERAPIE-BASIERTEN BEHANDLUNGSSTRATEGIE BEI PATIENTEN MIT HORMONREZEPTOR-POSITIVEM / HER2-NEGATIVEM, METASTASIERTEN BRUSTKREBS IN DER REAL-WORLD-SITUATION.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study aims to compare the time-to-treatment failure of a palbociclib + endocrine therapy against a pre-chosen mono-chemotherapy in a real world setting. Time-to-treatment failure (TTF) is defined as time from randomization to discontinuation of treatment due to disease progression, treatment toxicity, patient’s preference, or death.
    Furthermore the study will compare patient´s quality of life extensively.
    Das Ziel der PADMA Studie ist der Vergleich einer Behandlung mit Palbociclib und endokriner Therapie gegenüber einer Mono-Chemotherapie-Behandlung mit anschließender endokriner Erhaltungstherapie. Primärer Endpunkt der Studie ist die Dauer bis zum Therapieversagen (definiert als Progression der Erkrankung, Toxizität, Patientenpräferenz oder Tod).
    Außerdem wird im Rahmen der Studie ein umfangreiches Begleitprogramm zur Erhebung von Lebensqualitätsdaten durchgeführt.
    A.3.2Name or abbreviated title of the trial where available
    PADMA
    A.4.1Sponsor's protocol code numberGBG93
    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 SponsorGBG Forschungs GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportAMS Advanced Medical Services
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGBG Forschungs GmbH
    B.5.2Functional name of contact pointPADMA
    B.5.3 Address:
    B.5.3.1Street AddressMartin-Behaim-Straße 12
    B.5.3.2Town/ cityNeu-Isenburg
    B.5.3.3Post code63263
    B.5.3.4CountryGermany
    B.5.4Telephone number+49610274800
    B.5.5Fax number+4961027480440
    B.5.6E-mailPADMA@GBG.de
    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 IBRANCE
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd.
    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 namePalbociclib
    D.3.2Product code PD-0332991-00
    D.3.4Pharmaceutical form Capsule, hard
    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 INNPALBOCICLIB
    D.3.9.2Current sponsor codePD-0332991-00
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 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 IBRANCE
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd.
    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 namePalbociclib
    D.3.2Product code PD-0332991-00
    D.3.4Pharmaceutical form Capsule, hard
    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 INNPALBOCICLIB
    D.3.9.2Current sponsor codePD-0332991-00
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name IBRANCE
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd.
    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 namePalbociclib
    D.3.2Product code PD-0332991-00
    D.3.4Pharmaceutical form Capsule, hard
    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 INNPALBOCICLIB
    D.3.9.2Current sponsor codePD-0332991-00
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Capecitabine
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCapecitabine
    D.3.9.3Other descriptive nameCapecitabine
    D.3.9.4EV Substance CodeSUB12474MIG
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Epirubicin
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEpirubicin
    D.3.9.3Other descriptive nameEpirubicin
    D.3.9.4EV Substance CodeSUB06571MIG
    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.2.1.1.1Trade name Paclitaxel
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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.3.9.3Other descriptive namePaclitaxel
    D.3.9.4EV Substance CodeSUB09583MIG
    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: 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.2.1.1.1Trade name Vinorelbine
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVinorelbine
    D.3.9.1CAS number 71486-22-1
    D.3.9.3Other descriptive nameVinorelbine
    D.3.9.4EV Substance CodeSUB00069MIG
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Exemestane
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNExemestane
    D.3.9.3Other descriptive nameExemestane
    D.3.9.4EV Substance CodeSUB07492MIG
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Fulvestrant
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFulvestrant
    D.3.9.3Other descriptive nameFulvestrant
    D.3.9.4EV Substance CodeSUB13933MIG
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Letrozole
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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.3.9.3Other descriptive nameLetrozole
    D.3.9.4EV Substance CodeSUB08444MIG
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Tamoxifen
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTamoxifen
    D.3.9.1CAS number 10540-29-1
    D.3.9.3Other descriptive nameTamoxifen
    D.3.9.4EV Substance CodeSUB10825MIG
    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
    Metastatic breast cancer.
    Metastasierter Brustkrebs.
    E.1.1.1Medical condition in easily understood language
    Metastatic breast cancer.
    Metastasierter Brustkrebs.
    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 LLT
    E.1.2Classification code 10072737
    E.1.2Term Advanced breast cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 100000004864
    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 time-to-treatment failure (TTF) for patients randomized to receive pre-defined chemotherapy treatment strategy versus those randomized to receive palbociclib and endocrine therapy.
    Dauer bis zum Behandlungsversagen, definiert als die Dauer von der Randomisation bis zum Behandlungsabbruch aufgrund von Progression, Toxizität, Patientenpräferenz oder Tod.
    E.2.2Secondary objectives of the trial
    • To compare progression free survival (PFS) between treatment arms.
    • To compare time to first subsequent treatment (TFST).
    • To compare time to first subsequent chemotherapy (TFSCT).
    • To compare time to second subsequent treatment regimen (TSST).
    • To compare the overall survival between treatment arms.
    • To compare patient well-being and health care utilization by daily monitoring treatment impact (DMTI) content with Quality of Life (QoL) and degree of bother by side-effects, number and duration of phone calls, and patient visits to investigator sites.
    • To compare patient reported outcomes, measured by FACT-B.
    • To compare time-to-deterioration in Trial Outcome Index-Physical/Functional/Breast (TOI-PFB derived from FACT-B).
    • To compare safety and tolerability between the two arms.
    • To compare treatment compliance between the two arms.
    • Vergleich des progressionsfreien Überlebens (PFS) zwischen den beiden Behandlungsarmen.
    • Vergleich der Dauer bis zur nächstfolgenden Behandlung (TFST) zwischen den beiden Behandlungsarmen.
    • Vergleich der Dauer bis zur nächstfolgenden Chemotherapie (TFSCT) zwischen den beiden Behandlungsarmen.
    • Vergleich der Dauer bis zur zweiten nachfolgenden Behandlung (TSST) zwischen den beiden Behandlungsarmen.
    • Vergleich des Gesamtüberlebens zwischen den beiden Behandlungsarmen.
    • Vergleich des Gesundheitszustandes und der Inanspruchnahme von Gesundheitseinrichtungen zwischen den beiden Behandlungsarmen anhand des Daily Monitoring Treatment Impact (DMTI) einschließlich Quality-of-Life (QoL) - Daten und Beeinträchtigungen durch Nebenwirkungen sowie der Anzahl und Dauer von Anrufen und Patientenbesuchen an der Prüfstelle.
    PLUS vier weitere sekundäre Zielkriterien (siehe englische Beschreibung oben).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, willingness and ability to complete collection of data via study mobile must be obtained and documented according to the local regulatory requirements.
    2. Female or male patients.
    3. Age ≥ 18 years old.
    4. Metastatic invasive hormone receptor positive and HER2 negative breast cancer (histologically confirmed).
    5. Patients who in the opinion of the treating physician are candidates suitable for randomization for mono-chemotherapy treatment, that has either an approved label in Europe and/or is supported by guidelines for the treatment of first-line advanced BC, which are based on evidence on safety and efficacy in this setting.
    6. Symptomatic or asymptomatic metastatic breast cancer.
    7. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).
    8. Life-expectancy > 6 months.
    9. For female patients: The patients need to be either A) of non-childbearing potential (documented postmenopausal or post hysterectomy) B) childbearing potential with negative serum or urinary pregnancy test (in this case patients need to use highly effective non-hormonal contraceptive methods).
    1. Die schriftliche Einwilligungserklärung muss vor dem Beginn sämtlicher Prüfplan-spezifischer Prozeduren vorliegen. Die Einwilligungserklärung beinhaltet die Bereitschaft der Patientin, die Studienbehandlung sowie die Nachsorge-Zeit (Follow-up) durchzuführen. Außerdem muss die Bereitschaft und Fähigkeit der Patientin gegeben sein, Daten mit einem studienspezifischen Mobiltelefon gemäß lokaler regulatorischer Vorgaben zu erheben.
    2. Weibliche oder männliche Patienten.
    3. Alter ≥ 18 Jahre.
    4. Metastasierter, invasiver, Hormonrezeptor-positiver / HER2-negativer Brustkrebs (histologisch bestätigt).
    5. Patienten, die nach ärztlicher Beurteilung für eine Mono-Chemotherapie geeignet sind, die entweder eine europäische Zulassung in dieser Indikation hat und/oder deren Anwendung durch Richtlinien für die Behandlung von metastasiertem Brustkrebs aufgrund der gezeigten Sicherheit und Wirksamkeit in dieser Konstellation angezeigt ist.
    6. Symptomatischer oder asymptomatischer metastasierter Brustkrebs.
    7. Rückentwicklung aller akut toxischen Effekte aus vorhergehenden Anti-Krebs-Therapien oder chirurgischen Eingriffen zu Grad ≤ 1 gemäß NCI CTCAE Version 4.0. Alopezie oder andere Effekte, die nach Beurteilung des Prüfarztes kein Sicherheitsrisiko für die Patienten darstellen, sind davon ausgenommen.
    8. Lebenserwartung > 6 Monate.
    9. Für weibliche Patientinnen: entweder A) nicht gebärfähig (postmenopausaler oder post-hysterektomischer Zustand) oder B) gebärfähig mit negativem Serum- oder Urin-Schwangerschaftstest (in diesem Falle muss die Patientin eine hoch-effektive nicht-hormonelle Verhütungsmethode anwenden).
    E.4Principal exclusion criteria
    1. Indication for poly-chemotherapy or single-agent endocrine therapy only or bevacizumab.
    2. Asymptomatic oligometastases of the bone as the only site of metastatic disease.
    3. Uncontrolled/untreated central nervous system lesions.
    4. Patients who received treatment for metastatic/relapsed breast cancer.
    5. Inadequate organ function as per physician’s assessment immediate prior to randomization.
    6. Treatment with preparations containing St. John´s Wort within the last 7 days prior to randomization and/or concurrent use.
    7. Known severe hypersensitivity reactions to compounds or excipients similar to palbociclib, planned chemotherapy or planned endocrine therapy.
    8. Existing contraindication against the use of palbociclib, planned chemotherapy or planned endocrine therapy.
    9. Patients with hereditary problems of galactose intolerance, the Lapp lactase deficiency, and glucose-galactose malabsorption.
    10. Female patients: pregnancy or lactation at the time of randomization or intention to become pregnant during the study and up to six months after treatment. Male patients: Intention to beget a child during the study and up to six months after treatment.
    1. Indikation für eine Poly-Chemotherapie oder alleinige endokrine Therapie oder Bevacizumab-Monotherapie.
    2. Asymptomatische Knochen-Oligometastasen als einzige Lokalisation der metastasierten Erkrankung.
    3. Unkontrollierte/unbehandelte Läsionen im zentralen Nervensystem.
    4. Patienten, die bereits eine Behandlung für metastasierten bzw. rezidivierenden Brustkrebs erhalten haben.
    5. Unzureichende Organfunktion nach prüfärztlicher Beurteilung vor Randomisation.
    6. Einnahme von Produkten, die Johanniskraut enthalten, innerhalb von sieben Tagen vor der Randomisation und/oder Therapie während der Behandlungsphase indiziert.
    7. Bekannte schwerwiegende Hypersensitivitätsreaktionen gegen Wirk- oder Hilfsstoffe, die Palbociclib bzw. der geplanten Chemotherapie oder der geplanten endokrinen Therapie ähneln.
    8. Bestehende Gegenanzeige gegen die Verabreichung von Palbociclib bzw. der geplanten Chemotherapie oder der geplanten endokrinen Therapie.
    9. Patienten mit hereditärer Galactose-Intoleranz, Lapp-Lactase-Mangel oder Glucose-Galactose-Malabsorption.
    10. Weibliche Patienten, die schwanger sind bzw. stillen oder während der Studie bzw. sechs Monate nach Behandlungsende schwanger werden möchten. Männliche Patienten, die während der Studie bzw. sechs Monate nach Behandlungsende ein Kind zeugen möchten.
    E.5 End points
    E.5.1Primary end point(s)
    Time-to-treatment failure (TTF) is defined as time from randomization to discontinuation of treatment due to disease progression, treatment toxicity, patient’s preference, or death.
    Dauer bis zum Behandlungsversagen (TTF) definiert als die Dauer von Randomisation bis zum Behandlungsabbruch aufgrund von Progression, Toxizität, Patientenpräferenz oder Tod.
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 months after first patient randomised
    60 Monate nach Randomisation der ersten Patientin.
    E.5.2Secondary end point(s)
    • Progression free survival is defined as the time from randomization to first progression as assessed by the investigator or death, whichever occurs first.
    • Time to first subsequent treatment (TFST) is defined as the time from randomization to start of first subsequent anti-cancer treatment or death.
    • Time to first subsequent chemotherapy (TFSCT) is defined as the time from randomization to start of first subsequent anticancer chemotherapy or death.
    • Time to second subsequent treatment regimen (TSST) is defined as the time from randomization to start of second subsequent treatment regimen or death.
    • Overall survival is defined as the time from randomization to death due to any reason.
    • Safety and tolerability (safety by toxicity grades is defined by the NCI CTCAE version 4.0).
    • Treatment compliance defined as treatment reductions, delays or permanent discontinuation of treatment. The reason for termination includes aspects of efficacy (i.e. termination due to tumor relapse), safety (i.e. termination due to adverse events) and compliance (i.e. termination due to patient's withdrawal of consent).
    • Patient-reported breast cancer-specific quality of life.
    • Time-to-deterioration (TTD) in TOI-PFB (FACT-B) is defined as an increase of 5 or more score points from baseline.
    • Content with QoL and degree of bother by side-effects measured by two daily FACT-derived questions on a 5-point scale for level of Agreement.
    • Number and duration of phone calls, and patients visits to investigator sites.
    • Progressionsfreies Überleben. Definiert als die Zeit von der Randomisation bis zur ersten Progression (nach prüfärztlicher Beurteilung) oder bis zum Tod, je nachdem was als erstes eintritt.
    • Dauer bis zur ersten Folgebehandlung (TFST). Definiert als die Zeit von der Randomisation bis zur ersten Folgebehandlung einer Krebserkrankung oder bis zum Tod.
    • Dauer bis zur nächsten Chemotherapie (TFSCT). Definiert als die Zeit von der Randomisation bis zum Beginn der nächsten Chemotherapie einer Krebserkrankung oder bis zum Tod.
    • Zeit bis zur zweiten Folgebehandlung (TSST). Definiert als die Zeit von der Randomisation bis zum Beginn der zweiten Folgebehandlung oder bis zum Tod.
    • Gesamtüberleben. Definiert als die Zeit von der Randomisation bis zum Tod (unbeachtet der Ursache).
    • Sicherheit und Verträglichkeit, beurteilt nach den NCI CTCAE Kriterien Version 4.0.
    • Behandlungscompliance. Definiert als Dosisreduktion, Behandlungsverschiebung oder vollständiger Behandlungsabbruch. Gründe für Behandlungsabbrüche schließen Aspekte der Wirksamkeit (z.B. Abbruch wegen Rezidiv), der Sicherheit (z.B. Abbruch wegen unerwünschter Nebenwirkungen) und der Compliance (z.B. Abbruch wegen Rücknahme der Patienteneinwilligung) ein.
    • Beurteilung der brustkrebsspezifischen Lebensqualität durch die Patienten (PRO).
    • Dauer bis zur Verschlechterung (Time-to-Deterioration TTD) gemäß der TOI-PFB (FACT-B) Kriterien. Definiert als eine Erhöhung gegenüber dem Basiswert um mindestens 5 Punkte.
    • Zufriedenheit mit Lebensqualität und Ausmaß der Beeinträchtigung durch Nebenwirkungen. Gemessen mittels zweier täglicher Fragen (vom FACT abgeleitet) auf einer 5-Punkte-Skala für das Ausmaß der Zustimmung.
    • Anzahl und Dauer der Telefonanrufe und der Patientenbesuche an der Prüfstelle.
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 months after first patient randomised
    60 Monate nach Randomisation der ersten Patientin.
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Patient-reported outcome on quality of life data via study mobile (FACT-B questionnaire).
    Analyse von der von den Patienten mit dem studienspezifischen Mobiltelefon berichteten Lebensqualitätsdaten (FACT-B Fragebogen).
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned60
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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 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
    60 months after randomisation of the first patient.
    60 Monate nach Randomisation der ersten Patientin.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    None.
    Keine.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-08
    P. End of Trial
    P.End of Trial StatusOngoing
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