DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

Sponsor
Daiichi Sankyo, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03523585
Collaborator
Daiichi Sankyo Co., Ltd. (Industry), AstraZeneca (Industry)
600
227
3
73
2.6
0

Study Details

Study Description

Brief Summary

This study will compare DS 8201a to standard treatment.

Participants must have HER2 breast cancer that has been treated before.

Their cancer:
  • cannot be removed by an operation

  • has spread to other parts of the body

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The study is designed to compare DS 8201a versus standard of care (investigator's choice) in subjects with unresectable and/or metastatic breast cancer previously treated with T-DM1.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1
Actual Study Start Date :
Aug 1, 2018
Actual Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Trastuzumab deruxtecan (DS-8201a)

HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to treatment with DS-8201a

Drug: Trastuzumab deruxtecan
DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as intravenous (IV) dose
Other Names:
  • DS-8201a
  • Active Comparator: Trastuzumab+capecitabine

    HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Trastuzumab/capecitabine

    Drug: Capecitabine
    Investigator's choice Standard of Care when combined with trastuzumab or lapatinib
    Other Names:
  • Investigator's Choice Comparative Therapy
  • Drug: Trastuzumab
    Investigator's choice Standard of Care when combined with capecitabine
    Other Names:
  • Investigator's Choice Comparative Therapy
  • Active Comparator: Lapatinib+capecitabine

    HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Lapatinib/capecitabine

    Drug: Capecitabine
    Investigator's choice Standard of Care when combined with trastuzumab or lapatinib
    Other Names:
  • Investigator's Choice Comparative Therapy
  • Drug: Lapatinib
    Investigator's choice Standard of Care when combined with capecitabine
    Other Names:
  • Investigator's Choice Comparative Therapy
  • Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival (PFS) based on blinded independent central review (BICR) [Baseline up to 42 months postdose]

      Time from the date of randomization to the first objective documentation of radiographic disease progression via BICR according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1, or death due to any cause.

    Secondary Outcome Measures

    1. Overall survival (OS) [Baseline up to 78 months postdose]

      Time from the date of randomization to the date of death for any cause. If there is no death reported for a subject before the data cutoff for OS analysis, OS will be censored at the last contact date at which the subject is known to be alive.

    2. Objective response rate (ORR) based on BICR and investigator assessment [Baseline up to 78 months postdose]

      Percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR), based on BICR and investigator assessment

    3. Duration of response (DoR) based on BICR and investigator's assessment [Baseline up to 78 months postdose]

      Length of time response continued, based on BICR and investigator's assessment

    4. Progression-free survival (PFS) based on investigator's assessment [Baseline up to 42 months postdose]

      Time from the date of randomization to the first objective documentation of radiographic disease progression via investigator assessment, according to mRECIST version 1.1, or death due to any cause.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Is the age of majority in their country

    • Has pathologically documented breast cancer that:

    1. is unresectable or metastatic

    2. has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory

    3. was previously treated with ado-trastuzumab emtansine (T-DM1)

    • Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy)

    • Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.

    • Male and female participants 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:

    1. 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males)

    2. 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)

    3. 7 months after the last dose of trastuzumab/capecitabine

    • Has adequate hematopoietic, renal and hepatic functions
    Exclusion Criteria:
    • Has previously participated in an antibody drug conjugate study sponsored by Daiichi Sankyo. Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy

    • Has had prior treatment with capecitabine

    • Has uncontrolled or significant cardiovascular disease

    • Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening

    • Has active central nervous system (CNS) metastases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ironwood Cancer Research Centers Chandler Arizona United States 85224-5665
    2 UCLA Hematology Oncology - Main Site Los Angeles California United States 90095
    3 Pacific Cancer Care Monterey California United States 93940
    4 Sharp Memorial Hospital San Diego California United States 92123
    5 Innovative Clinical Research Institute Whittier California United States 90603
    6 Smilow Cancer Hospital at Yale New Haven New Haven Connecticut United States 06510
    7 Washington Cancer Institute Washington District of Columbia United States 20010
    8 Florida Cancer Specialists-Broadway Fort Myers Florida United States 33901
    9 Piedmont Cancer Institute, PC Atlanta Georgia United States 30318
    10 Kapiolani Medical Center for Women and Children/Univ of HI Honolulu Hawaii United States 96826
    11 Loyola University Health System Maywood Illinois United States 60153
    12 Community Hospital Munster Indiana United States 46321
    13 Norton Cancer Institute Louisville Kentucky United States 40207
    14 Maine Center for Cancer Medicine Scarborough Maine United States 04074
    15 University of Maryland Baltimore Maryland United States 21201
    16 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    17 Dana Farber Cancer Institute Boston Massachusetts United States 02215
    18 Henry Ford Hospital Detroit Michigan United States 48202
    19 Cornell-Beshore Cancer Institute Joplin Missouri United States 64804
    20 Saint Luke's Cancer Institute Kansas City Missouri United States 64111
    21 Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC Kansas City Missouri United States 64132
    22 Washington University Saint Louis Missouri United States 63110
    23 North Shore Hematology Oncology Associates, PC East Setauket New York United States 11733
    24 Memorial Sloan-Kettering Cancer Center (MSKCC) - New York New York New York United States 10065
    25 University of Cincinnati Medical Center Cincinnati Ohio United States 45267-0502
    26 Cleveland Clinic Main Campus Cleveland Ohio United States 44195
    27 The Ohio State University Columbus Ohio United States 43235
    28 Dayton Physicians, LLC Kettering Ohio United States 45409
    29 Abramson Cancer Center Philadelphia Pennsylvania United States 19104
    30 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    31 UPMC Cancer Center Pittsburgh Pennsylvania United States 15213
    32 Tennessee Oncology, PLLC Chattanooga Chattanooga Tennessee United States 37404
    33 The West Clinic Germantown Tennessee United States 38138
    34 SCRI - Tennessee Oncology Nashville Tennessee United States 37203
    35 UT Southwestern Medical Center Dallas Texas United States 75390-8857
    36 MD Anderson Cancer Center Houston Texas United States 77030
    37 The Methodist Hospital Research Institute Houston Texas United States 77030
    38 The University of Texas Health Science Center at Tyler Tyler Texas United States 75708
    39 Community Cancer Trials of Utah Ogden Utah United States 84405
    40 Virginia Cancer Specialists, PC Fairfax Virginia United States 22031
    41 MultiCare Health System Institute for Research and Innovation Tacoma Washington United States 98405
    42 St Vincent's Hospital Sydney Darlinghurst New South Wales Australia 2010
    43 Liverpool Hospital Liverpool New South Wales Australia 2170
    44 Macquarie University Hospital Sydney New South Wales Australia 2109
    45 The Tweed Hospital Tweed Heads New South Wales Australia 2485
    46 Princess Alexandra Hospital Woolloongabba Queensland Australia 4102
    47 Ashford Cancer Centre Research Kurralta Park South Australia Australia 5037
    48 Box Hill Hospital Box Hill Victoria Australia 3128
    49 Frankston Hospital Frankston Victoria Australia 3199
    50 Peninsula and South Eastern Haematology & Oncology Group Frankston Victoria Australia 3199
    51 Austin Health Heidelberg Victoria Australia 3084
    52 Peter MacCallum Cancer Centre Melbourne Victoria Australia 3000
    53 Sunshine Hospital Saint Albans Victoria Australia 3021
    54 South West Oncology Warrnambool Victoria Australia 3280
    55 Ballarat Oncology & Haematology Service Wendouree Victoria Australia 3355
    56 St John of God Subiaco Hospital Subiaco Western Australia Australia 6008
    57 Calvary North Adelaide Hospital Bruce Australia 2614
    58 Universitair Ziekenhuis Brussel Bruxelles Belgium 1090
    59 Cliniques Universitaires Saint-Luc Bruxelles Belgium 1200
    60 AZ Maria Middelares Gent Belgium 9000
    61 Az Groeninge Kortrijk Belgium 8500
    62 UZ Leuven Leuven Belgium 3000
    63 CHU UCL Namur site de Sainte Elisabeth Namur Belgium 5000
    64 NOB - Núcleo de Oncologia da Bahia Salvador Bahia Brazil 40170-110
    65 AMO - Assistência Multidisciplinar em Oncologia Salvador Bahia Brazil 41950-640
    66 Pronutrir Fortaleza Ceará Brazil 60810-180
    67 Oncobio Servicos de Saude Nova Lima Minas Gerais Brazil 34000
    68 HGB - Hospital Giovanni Battista - Mãe de Deus Center Porto Alegre Rio Grande Do Sul Brazil 90110-270
    69 CliniOnco - Tratamento Integrado do Câncer Porto Alegre Rio Grande Do Sul Brazil 90430-090
    70 Escosteguy Barrios, Carlos Henrique Porto Alegre Rio Grande Do Sul Brazil 90610-000
    71 Hospital Nossa Senhora da Conceição Porto Alegre Rio Grande Do Sul Brazil 91350-200
    72 Clínica de Neoplasias Litoral Ltda. Itajaí Santa Catarina Brazil 88301-220
    73 CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia Santo André Sao Paulo Brazil 09060-650
    74 IBCC - Instituto Brasileiro de Controle do Câncer São Paulo Sao Paulo Brazil 03102-002
    75 COI - Clínicas Oncológicas Integradas Rio De Janeiro Brazil 22793-080
    76 Sociedade Beneficiente de Senhoras Hospital Sírio Libanês São Paulo Brazil 01308
    77 A. C. Camargo Cancer Center São Paulo Brazil 01509-900
    78 Fakultni nemocnice Brno Brno Czechia 625 00
    79 Fakultni nemocnice Olomouc Olomouc Czechia 775 20
    80 Fakultni nemocnice v Motole Prague 5 Czechia 150 06
    81 Nemocnice Na Bulovce Praha Czechia 180 81
    82 Hôpital Nord - CHU Marseille Marseille cedex 20 Bouches-du-Rhône France 13915
    83 Centre François Baclesse Caen Cedex 05 Calvados France 14076
    84 CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie Plérin Cotes d'Armor France 22190
    85 Centre Georges François Leclerc Dijon cedex Côte-d'Or France 21079
    86 CHU Besançon - Hôpital Jean Minjoz Besançon Doubs France 25030
    87 CHU Brest - Hôpital Morvan Brest Cedex Finistere France 29609
    88 Hôpital Privé d'Antony Antony Hauts De Seine France 92160
    89 Centre René Huguenin Saint-Cloud Hauts De Seine France 92110
    90 Clinique Clementville Montpellier Herault France 34070
    91 Institut Régional du Cancer de Montpellier Montpellier Herault France 34298
    92 CRLCC Eugene Marquis Rennes cedex Ille Et Vilaine France 35042
    93 Centre Oscar Lambret Lille cedex Nord France 59020
    94 Centre de cancerologie les Dentellieres Valenciennes Nord France 59300
    95 Institut Curie - site de Paris Paris Cedex 05 Paris France 75005
    96 Centre Hospitalier de la côte Basque Bayonne Cedex Pyrenees Atlantiques France 64109
    97 Centre Hospitalier Lyon Sud Pierre Benite cedex Rhone France 69495
    98 Clinique Victor Hugo - Centre Jean Bernard Le Mans Cedex 02 Sarthe France 72015
    99 Centre Henri Becquerel Rouen Seine Maritime France 76038
    100 Institut Sainte Catherine Avignon Cedex 9 Vaculuse France 84918
    101 Institut Gustave Roussy Villejuif cedex Val De Marne France 94805
    102 Institut Régional du Cancer de Montpellier Montpellier France 34298
    103 Institut Curie - site de Paris Paris France 75005
    104 Hopital Tenon Paris France 75020
    105 Klinikum rechts der Isar der TU Muenchen Muenchen Bayern Germany 81675
    106 Marienhospital Bottrop gGmbH Bottrop Rheinland Pfalz Germany 46236
    107 Universitaetsklinikum Schleswig-Holstein - Campus Luebeck Luebeck Schleswig Holstein Germany 23538
    108 Helios-Kliniken Berlin-Buch Berlin Germany 13125
    109 Universitaetsklinikum Duesseldorf AoeR Düsseldorf Germany 40225
    110 Universitaetsklinikum Erlangen Erlangen Germany 91054
    111 Kliniken Koeln Koeln Germany 51067
    112 Universitaetsklinikum Leipzig AoeR Leipzig Germany 04103
    113 Klinikum der Universitaet Muenchen - Campus Grosshardern Munich Germany 81377
    114 Universitaetsklinikum Muenster Müenster Germany 48149
    115 Haematologisch-Onkologische Schwerpunktpraxis Troisdorf Germany 53840
    116 251 General Air Force Hospital Athens Greece 11525
    117 General Hospital of Athens "Alexandra" Athens Greece 11528
    118 General Oncology Hospital of Kifissia " Agioi Anargyroi" Athens Greece 14564
    119 University General Hospital of Heraklion Heraklion Greece 71110
    120 Euromedica General Clinic Thessaloniki Thessaloníki Greece 54645
    121 Rambam Health Care Center Haifa Israel 3109601
    122 Shaare Zedek Medical Center Jerusalem Israel 9103102
    123 Hadassah University Hospital - Ein Kerem Jerusalem Israel 9112001
    124 Sapir Medical Center, Meir Hospital Kfar Saba Israel 4428164
    125 Rabin Medical Center-Beilinson Campus Petah tikva Israel 49100
    126 Chaim Sheba Medical Center Ramat Gan Israel 52363
    127 Tel Aviv Sourasky Medical Center Tel Aviv Israel 6423906
    128 Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) Monza Milano Italy 20900
    129 IRCCS Centro di Riferimento Oncologico Aviano Pordenone Italy 33081
    130 Ospedale Sacro Cuore Don Calabria Negrar Verona Italy 37024
    131 Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) Bergamo Italy 24127
    132 Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi Bologna Italy 40138
    133 Azienda Ospedaliera Universitaria Arcispedale Sant'Anna Cona Italy 44124
    134 Istituto Nazionale per la Ricerca sul Cancro di Genova Genova Italy 16132
    135 Azienda Ospealiera della Provincia di Lecco Lecco Italy 23900
    136 Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte Messina Italy 98158
    137 Ospedale San Raffaele Milano Italy 20132
    138 Fondazione IRCCS Istituto Nazionale dei Tumori Milano Italy 20133
    139 IEO Istituto Europeo di Oncologia Milano Italy 20141
    140 A.O.U. Policlinico di Modena Modena Italy 41124
    141 Istituto Nazionale Tumori Fondazione G. Pascale Napoli Italy 80131
    142 IOV - Istituto Oncologico Veneto IRCCS Padova Italy 35128
    143 Azienda Ospedaliero Universitaria di Parma Parma Italy 43100
    144 Fondazione IRCCS Policlinico San Matteo Pavia Italy 27100
    145 Azienda Ospedaliero Universitaria Pisana Pisa Italy 56126
    146 Azienda Ospedaliera Città della Salute e della Scienza di Torino Torino Italy 10126
    147 Fukushima Medical University Hospital Fukushima-shi Fukushima-Ken Japan 960-1295
    148 Kindai University Hospital Osakasayama-shi Osaka-Fu Japan 589-8511
    149 Kindai University Hospital Ōsakasayama-shi Osaka-Fu Japan 589-8511
    150 National Cancer Center Hospital Chuo Ku Tokyo-To Japan 104-0045
    151 NHO Shikoku Cancer Center Ehime Japan 791-0280
    152 NHO Kyushu Cancer Center Fukuoka Japan 811-1395
    153 Hiroshima City Hiroshima Citizens Hospital Hiroshima Japan 730-8518
    154 NHO Hokkaido Cancer Center Hokkaido Japan 003-0804
    155 Hyōgo College of Medicine Hospital Hyōgo Japan 663-8501
    156 St. Marianna University School of Medicine Hospital Kanagawa Japan 216-8511
    157 Kanagawa Cancer Center Kanagawa Japan 241-8515
    158 Kyoto University Hospital Kyoto Japan 606-8507
    159 Tohoku University Hospital Miyagi Japan 980-8574
    160 Aichi Cancer Center Hospital Nagoya Japan 464-8681
    161 Niigata Cancer Center Hospital Niigata Japan 951-8566
    162 Okayama University Hospital Okayama Japan 700-8558
    163 NHO Osaka National Hospital Osaka Japan 540-0006
    164 Osaka International Cancer Institute Osaka Japan 541-8567
    165 Saitama Cancer Center Saitama Japan 362-0806
    166 Shizuoka Cancer Center Shizuoka Japan 411-8777
    167 Toranomon Hospital Tokyo Japan 105-8470
    168 The Cancer Institute Hospital of JFCR Tokyo Japan 135-8550
    169 Tokyo Medical University Hospital Tokyo Japan 160-0023
    170 Chungbuk National University Hospital Cheongju-si Chungcheongbuk-do Korea, Republic of 28644
    171 Inha University Hospital Incheon Gyeonggi-do Korea, Republic of 22332
    172 Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Korea, Republic of 13620
    173 The Catholic University of Korea, St. Vincent's Hospital Suwon-si Gyeonggi-do Korea, Republic of 16247
    174 Ajou University Hospital Suwon Gyeonggi-do Korea, Republic of 16499
    175 Kyungpook National University Chilgok Hospital Daegu Korea, Republic of 41404
    176 National Cancer Center Goyang-si Korea, Republic of 10408
    177 Korea University Anam Hospital Seoul Korea, Republic of 02841
    178 Seoul National University Hospital Seoul Korea, Republic of 03080
    179 Severance Hospital, Yonsei University Seoul Korea, Republic of 03772
    180 Asan Medical Center Seoul Korea, Republic of 05505
    181 Samsung Medical Center Seoul Korea, Republic of 06351
    182 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of 06591
    183 ICO Badalona - Hospital Universitari Germans Trias i Pujol Badalona Barcelona Spain 08916
    184 ICO l'Hospitalet - Hospital Duran i Reynals L'Hospitalet De Llobregat Barcelona Spain 08908
    185 Hospital de Especialidades de Jerez de la Frontera Jerez De La Frontera Cádiz Spain 11407
    186 Complejo Hospitalario Universitario A Coruña A Coruña La Coruña Spain 15006
    187 Hospital Universitario de Canarias San Cristobal de la Laguna Tenerife Spain 38320
    188 Hospital Infanta Cristina Badajoz Spain 06007
    189 Hospital Quironsalud Barcelona Barcelona Spain 08023
    190 Hospital Universitari Vall d'Hebron Barcelona Spain 08035
    191 Hospital Clinic de Barcelona Barcelona Spain 08036
    192 Hospital del Mar Barcelona Spain 8003
    193 Hospital Universitari Arnau de Vilanova Lleida Spain 25198
    194 Hospital General Universitario Gregorio Marañon Madrid Spain 28007
    195 MD Anderson Cancer Centre Madrid Spain 28033
    196 Hospital Universitario Clinico San Carlos Madrid Spain 28040
    197 Hospital Clinico Universitario Virgen de la Victoria Málaga Spain 29010
    198 Hospital Universitario de Salamanca Salamanca Spain 37370
    199 Hospital Universitario Virgen Macarena Sevilla Spain 41009
    200 Hospital Universitario Virgen del Rocio Sevilla Spain 41013
    201 Instituto Valenciano de Oncologia IVO Valencia Spain 46009
    202 Hospital Universitario Miguel Servet Zaragoza Spain 50009
    203 Acibadem Adana Hospital Adana Turkey 01130
    204 Adana Numune Training and Research Hospital Adana Turkey 01370
    205 Ankara Yildirim Beyazit Uni. Med. Fac.Ankara City Hospital Ankara Turkey 6800
    206 Akdeniz University Medical Faculty Antalya Turkey 07058
    207 Uludag University Medical Faculty Bursa Turkey 16059
    208 Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty Istanbul Turkey 34098
    209 Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital Istanbul Turkey 34147
    210 Medipol University Medical Faculty Istanbul Turkey 34214
    211 Medical Park Goztepe Hospital Istanbul Turkey 34732
    212 Istanbul Medeniyet Uni Goztepe Training & Research Hospital Istanbul Turkey 34854
    213 Kartal Lutfi Kirdar Research and Training Hospital Istanbul Turkey 34890
    214 Izmir Medicalpark Hospital İzmir Turkey 35530
    215 Konya Necmettin Erbakan University Meram Faculty of Medicine Konya Turkey 42080
    216 Sakarya Traning and Research Hospital Sakarya Turkey 54187
    217 Medical Park Samsun Hastanesi Samsun Turkey 55200
    218 Namik Kemal University Tekirdağ Turkey 59100
    219 Royal Cornwall Hospital Truro Cornwall United Kingdom TR1 3LJ
    220 Royal Devon and Exeter Hospital (Wonford) Exeter Devon United Kingdom EX2 5DW
    221 Derriford Hospital Plymouth Devon United Kingdom PL6 8BQ
    222 Aberdeen Royal Infirmary Aberdeen Grampian Region United Kingdom AB25 2ZB
    223 Queen Mary University of London London Greater London United Kingdom EC1M 6BQ
    224 University College London Hospitals London Greater London United Kingdom NW1 2PG
    225 Sarah Cannon Research Institute UK London Greater London United Kingdom W1G 6AD
    226 Western General Hospital Edinburgh Lothian Region United Kingdom EH4 2XU
    227 Nottingham University Hospitals City Campus Nottingham Nottinghamshire United Kingdom NG5 1PB

    Sponsors and Collaborators

    • Daiichi Sankyo, Inc.
    • Daiichi Sankyo Co., Ltd.
    • AstraZeneca

    Investigators

    • Study Director: Global Team Leader, Daiichi Sankyo, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daiichi Sankyo, Inc.
    ClinicalTrials.gov Identifier:
    NCT03523585
    Other Study ID Numbers:
    • DS8201-A-U301
    • 2018-000221-31
    • 184017
    • DESTINY-B02
    First Posted:
    May 14, 2018
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Daiichi Sankyo, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 12, 2022