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    Summary
    EudraCT Number:2018-000222-61
    Sponsor's Protocol Code Number:DS8201-A-U302
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-10-03
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-000222-61
    A.3Full title of the trial
    A Phase 3, multicenter, randomized, open-label, active-controlled study of DS-8201a, an anti-HER2-antibody drug
    conjugate, versus ado-trastuzumab emtansine (T-DM1) for HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane
    Etude de phase III, multicentrique, randomisée, en ouvert, comparant le DS-8201a, un anticorps conjugué anti-HER2, au traitement de référence, l’ado-trastuzumab emtansine (T-DM1), chez les patients atteints d’un cancer du sein HER2 positif, non résécable et/ou métastatique, préalablement traités par trastuzumab et taxanes.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Testing a new targeted therapy (DS-8201a) against ado-trastuzumab emtansine (T-DM1) for patients with advanced-stage breast cancer previously treated with trastuzumab and taxane.
    Comparaison d’un nouveau traitement ciblé (DS-8201a) à l’ado-trastuzumab emtansine (T-DM1) chez des patients atteints d’un cancer du sein de stade avancé précédemment traités par trastuzumab et taxane.
    A.4.1Sponsor's protocol code numberDS8201-A-U302
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03529110
    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 SponsorDaiichi Sankyo Inc.
    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 supportDaiichi Sankyo Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Inc.
    B.5.2Functional name of contact pointNot Available
    B.5.3 Address:
    B.5.3.1Street Address211 Mt Airy Rd
    B.5.3.2Town/ cityBasking Ridge
    B.5.3.3Post codeNJ 07920
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 908 992 6400
    B.5.6E-maileu_cta@dsi.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.3.2Product code DS-8201a
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtrastuzumab deruxtecan
    D.3.9.2Current sponsor codeDS-8201a
    D.3.9.3Other descriptive nameAnti-HER2 antibody-drug conjugate
    D.3.9.4EV Substance CodeSUB188940
    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 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: 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.2.1.1.1Trade name Kadcyla
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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 Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtrastuzumab emtansine
    D.3.9.1CAS number 1018448-65-1
    D.3.9.3Other descriptive nametrastuzumab emtansine
    D.3.9.4EV Substance CodeSUB35467
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.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
    Unresectable/metastatic breast cancer with human epidermal growth factor receptor 2 (HER2)-positive expression
    Cancer du sein non résécable/métastatique avec expression positive du récepteur 2 du facteur de croissance épidermique humain (HER2)
    E.1.1.1Medical condition in easily understood language
    advanced-stage breast cancer
    Cancer du sein avancé
    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 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 efficacy of DS 8201a to T-DM1 as measured by progression-free survival (PFS).
    Comparer l’efficacité du DS-8201a et celle du T-DM1 telle que mesurée par la survie sans progression (SSP).
    E.2.2Secondary objectives of the trial
    • To further compare the efficacy of DS-8201a to T-DM1 on:
    - Overall survival (OS);
    - Objective response rate (ORR);
    - Duration of response (DoR);
    - Clinical benefit rate (CBR).
    • To further determine pharmacokinetics (PK) of DS-8201a.
    • To further evaluate safety of DS-8201a compared to T-DM1.
    • To evaluate Health Economics and Outcomes Research (HEOR) endpoints for DS 8201a compared to T-DM1.
    •Comparer de manière plus approfondie l’efficacité du DS-8201a par rapport à celle du T-DM1 au regard des critères suivants :
    -survie globale (SG) ;
    -taux de réponse objective (TRO) ;
    -durée de réponse (DR) ;
    -taux de bénéfice clinique (TBC).
    •Déterminer de manière plus approfondie la pharmacocinétique (PK) du DS-8201a.
    •Évaluer de manière plus approfondie la sécurité d’emploi du DS-8201a par rapport à celle du T-DM1.
    •Évaluer les critères d’évaluation liés à la recherche sur l’économie de la santé et les résultats (HEOR, Health Economics and Outcomes Research) pour le DS-8201a par rapport au T-DM1.
    Objectifs exploratoires :
    •Évaluer les biomarqueurs potentiels (par exemple, dosage sérique du domaine extracellulaire du récepteur HER2 [HER2ECD]).
    •Évaluer les relations entre exposition et réponse pour les critères d’évaluation de l’efficacité et de la sécurité d’emploi.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adults ≥18 years old. (Please follow local regulatory requirements if the legal age of consent for study participation is >18 y old.)
    • Pathologically documented breast cancer that:
    - is unresectable or metastatic
    - has confirmed HER2 positive expression as determined according to American Society of Clinical Oncology – College of American Pathologists guidelines evaluated at a central laboratory.
    - was previously treated with trastuzumab and taxane in the advanced/metastatic setting or progressed within 6 mo after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane.
    • Documented radiologic progression (during or after most recent treatment or within 6 mo after completing adjuvant therapy).
    • Subjects must be HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available.
    • Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 4.5 mo after the last dose of DS 8201a or 7 mo after the last dose of T-DM1
    • Adequate renal function, defined as:
    - Creatinine clearance ≥ 30 mL/min, as calculated using the Cockcroft-Gault equation
    • Adequate hepatic function, defined as:
    - Total bilirubin ≤ 1.5 × upper limit of normal (ULN) if no liver metastases or < 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline
    and
    - Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 5 × ULN
    •Adultes âgés de ≥ 18 ans. (Veuillez suivre les exigences règlementaires locales si l’âge légal du consentement pour la participation à l’étude est > 18 ans.)
    •Cancer du sein confirmé à l’anatomopathologie qui :
    -est non résécable ou métastatique ;
    -présente une expression HER2 positive confirmée, telle que déterminée par évaluation en laboratoire central selon les directives de l’American Society of Clinical Oncology – College of American Pathologists (Société américaine d’oncologie clinique – École des pathologistes américains) ;
    -a déjà été traité par trastuzumab et taxane dans un contexte de stade avancé/métastatique ou a progressé dans les 6 mois suivant un traitement néoadjuvant ou adjuvant impliquant un schéma posologique incluant trastuzumab et taxane.
    •Progression radiologique documentée (pendant ou après le traitement le plus récent ou dans les 6 mois suivant la fin du traitement adjuvant).
    •Les patients doivent être positifs pour HER2, comme confirmé par l’évaluation par le laboratoire central de l’échantillon de tissu tumoral le plus récent disponible. Si aucun tissu archivé n’est disponible, une biopsie fraîche est nécessaire.
    •Les patients de sexe masculin ou féminin aptes à procréer/en âge d’avoir des enfants doivent accepter d’utiliser une forme de contraception très efficace ou s’abstenir de rapports sexuels pendant l’étude et jusqu’à la fin de l’étude, ainsi que pendant au moins 4,5 mois après la dernière dose de DS-8201a ou 7 mois après la dernière dose de T-DM1.
    •Fonction rénale adéquate, définie par :
    -clairance de la créatinine ≥ 30 ml/min, comme calculée au moyen de l’équation de Cockcroft-Gault.
    •Fonction hépatique adéquate, définie par :
    -bilirubine totale ≤ 1,5 × limite supérieure de la normale (LSN) en l’absence de métastases hépatiques ou < 3 × LSN en présence d’un syndrome de Gilbert documenté (hyperbilirubinémie non conjuguée) ou de métastases hépatiques à la référence ; et
    -aspartate aminotransférase (ASAT) ou alanine aminotransférase (ALAT) ≤ 5 × LSN.
    E.4Principal exclusion criteria
    • Prior treatment with an anti-HER2-antibody drug conjugate (ADC).
    • Uncontrolled or significant cardiovascular disease, including any of the following:
    - History of myocardial infarction within 6 mo before randomization
    - History of symptomatic congestive heart failure (New York Heart Association Class II to IV)
    - Troponin levels consistent with myocardial infarction as defined according to the manufacturer within 28 d prior to randomization
    - Corrected QT interval prolongation to > 470 ms (females) or > 450 ms (male) based on average of Screening triplicate 12 lead electrocardiogram (ECG)
    - Left ventricular ejection fraction (LVEF) < 50% within 28 d prior to randomization
    • Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
    • Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
    - Subjects with clinically inactive brain metastases may be included in the study.
    - Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.
    •Traitement préalable avec un conjugué anticorps-médicament (CAM) anti-HER2.
    •Maladie cardiovasculaire non contrôlée ou significative, notamment l’une quelconque des pathologies suivantes :
    -antécédents d’infarctus du myocarde (dans les 6 mois qui précèdent la randomisation) ;
    -antécédents d’insuffisance cardiaque congestive symptomatique (de classe II à IV sur l’échelle de la New York Heart Association) ;
    -taux de troponine compatibles avec un infarctus du myocarde, comme défini selon le fabricant, dans les 28 jours précédant la randomisation ;
    -allongement de l’intervalle QT corrigé (QTc) à > 470 msec (femmes) ou > 450 msec (hommes) d’après la moyenne d’un électrocardiogramme (ECG) à 12 dérivations réalisé en triple exemplaire lors de la sélection ;
    -fraction d’éjection ventriculaire gauche (FEVG) < 50 % dans les 28 jours avant la randomisation.
    •Patient ayant des antécédents de pneumopathie interstitielle (PI)/pneumonite (non infectieuse) ayant nécessité des stéroïdes, présentant une PI/pneumonite ou suspecté de présenter une PI/pneumonite qui ne peut être exclue lors de l’examen d’imagerie réalisé lors de la sélection.
    •Patient présentant une compression médullaire ou des métastases du système nerveux central (SNC) cliniquement actives, défini comme un patient non traité et symptomatique, ou ayant besoin d’un traitement par corticoïdes ou anticonvulsivants pour contrôler les symptômes associés.
    -Les patients qui présentent des métastases cérébrales cliniquement inactives peuvent être inclus dans l’étude.
    -Les patients dont les métastases cérébrales traitées ne sont plus symptomatiques et n’ayant besoin d’aucun traitement par corticothérapie ou anticonvulsivants peuvent être inclus dans l’étude s’ils se sont rétablis de tous les effets toxiques aigus de la radiothérapie. Au moins 2 semaines doivent s’être écoulées entre la fin de la radiothérapie du cerveau entier et l’inclusion dans l’étude.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is PFS as determined by blinded independent central review (BICR).
    SSP tel que déterminée par le BICR.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The end of the study hypothesis-testing period is defined as the date when approximately 331 PFS events per blinded independent central review (BICR) have been observed.
    L’analyse principale de la SSP sera effectuée lorsqu’environ 331 événements de SSP évalués par le BICR auront été observés.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    • OS
    • ORR based on BICR and investigator assessment
    • DoR based on BICR and investigator assessment
    • CBR based on BICR and investigator assessment
    • PFS based on investigator assessment
    •SG.
    •TRO basé sur le BICR et l’évaluation de l’investigateur.
    •DR basée sur le BICR et l’évaluation de l’investigateur.
    •TBC basé sur le BICR et l’évaluation de l’investigateur.
    •SSP basée sur l’évaluation de l’investigateur.
    E.5.2.1Timepoint(s) of evaluation of this end point
    If the test of the primary endpoint, PFS based on BICR, is statistically significant, selected secondary endpoints will be tested.
    Si l'analyse du critère principal, SSP tel que déterminée par le BICR, est statistiquement significative, les critères secondaires sélectionnés seront analysés.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA72
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Brazil
    Canada
    China
    France
    Germany
    Hong Kong
    Italy
    Japan
    Korea, Republic of
    Spain
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study hypothesis-testing period is defined as the date when approximately 331 PFS events per BICR have been observed. The study closure is defined as the date when the last subject discontinues study treatment and applicable follow-up occurs, or the study is ended by the Sponsor.
    La fin de la période de test de l’hypothèse de l’étude est définie comme la date à laquelle environ 331 événements de SSP auront été observés d’après l’examen central indépendant en aveugle (blinded independant central review, BICR). La clôture de l'étude est définie comme la date à laquelle le dernier patient arrêt le traitement de l'étude avec le suivi correspondant ou l'étude est arrêté par le promoteur.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months26
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months26
    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: 285
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 215
    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 state88
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 194
    F.4.2.2In the whole clinical trial 500
    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. If there is evidence that the subject is receiving benefit from treatment even though the subject has met a criterion for discontinuation as listed above, the subject may remain on study treatment after discussion with and approval from the Sponsor Medical Monitor.
    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 Decision2018-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-06
    P. End of Trial
    P.End of Trial StatusOngoing
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