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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523585
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : October 2, 2019
Sponsor:
Collaborators:
Daiichi Sankyo Co., Ltd.
AstraZeneca
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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
Breast Cancer Drug: Trastuzumab deruxtecan Drug: Capecitabine Drug: Lapatinib Drug: Trastuzumab 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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 Name: 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 Name: Investigator's Choice Comparative Therapy

Drug: Trastuzumab
Investigator's choice Standard of Care when combined with capecitabine
Other Name: 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 Name: Investigator's Choice Comparative Therapy

Drug: Lapatinib
Investigator's choice Standard of Care when combined with capecitabine
Other Name: Investigator's Choice Comparative Therapy




Primary Outcome Measures :
  1. Progression-free survival (PFS) based on blinded independent central review (BICR) [ Time Frame: Within 45 months ]
    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) [ Time Frame: At 45 months ]
    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 [ Time Frame: Within 45 months ]
    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 [ Time Frame: Within 45 months ]
    Length of time response continued, based on BICR and investigator's assessment

  4. Clinical benefit rate (CBR) based on BICR and investigator assessment [ Time Frame: Within 45 months ]
    Percentage of participants receiving clinical benefit (CR, PR or more than 6 months stable disease) from the treatment based on BICR and investigator assessment

  5. Progression-free survival (PFS) based on investigator's assessment [ Time Frame: Within 45 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. 4.5 months after the last dose of DS-8201a
    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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523585


Contacts
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Contact: (For Sites in Asia Only) Daiichi Sankyo Contact for Clinical Trial Information +81-3-6225-1111(M-F 9-5 JST) dsclinicaltrial@daiichisankyo.co.jp

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Locations
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United States, Arizona
Ironwood Cancer Research Centers Recruiting
Chandler, Arizona, United States, 85224-5665
Contact: Principal Investigator    480-314-6694    shtivelband@ironwoodcrc.com   
United States, California
UCLA Hematology Oncology - Main Site Recruiting
Los Angeles, California, United States, 90095
Contact: Principal Investigator    310-794-6500    shurvitz@mednet.ucla.edu   
Pacific Cancer Care Recruiting
Monterey, California, United States, 93940
Contact: Principal Investigator    831-375-4105    lstampleman@pacificcancercare.com   
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Principal Investigator    858-939-5052    jennifer.fisher@sharp.com   
Cancer Research Collaboration Recruiting
Santa Ana, California, United States, 92705
Contact: Principal Investigator    562-981-6101    wademsmith@breastlink.com   
Innovative Clinical Research Institute Recruiting
Whittier, California, United States, 90603
Contact: Principal Investigator    562-693-4477    omarathe@airesearch.us   
United States, Connecticut
Smilow Cancer Hospital at Yale New Haven Recruiting
New Haven, Connecticut, United States, 06510
Contact: Principal Investigator    860-714-5919    zrahman@stfranciscare.org   
United States, District of Columbia
Washington Cancer Institute Recruiting
Washington, District of Columbia, United States, 20010
Contact: Principal Investigator    202-877-9386    christopher.gallagher@medstar.net   
United States, Georgia
Piedmont Cancer Institute, PC Recruiting
Atlanta, Georgia, United States, 30318
Contact: Principal Investigator    717-724-6780    rsinha@piedmontcancerinstitute.com   
United States, Indiana
Community Hospital Recruiting
Munster, Indiana, United States, 46321
Contact: Principal Investigator    219-924-8178    mkassar@nwoncologypc.com   
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40207
Contact: Principal Investigator    502-899-3366    jeffrey.hargis@nortonhealthcare.org   
United States, Maine
Maine Center for Cancer Medicine Recruiting
Scarborough, Maine, United States, 04074
Contact: Principal Investigator    207-396-7600    battec@newecs.org   
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Principal Investigator    410-328-3546    ktkaczuk@umm.edu   
Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Contact: Principal Investigator    410-783-5858    driseberg@mdmercy.com   
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Principal Investigator    617-632-3339    ian_krop@dfci.harvard.edu   
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Principal Investigator    617-632-3339    ian_krop@dfci.harvard.edu   
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Principal Investigator    313-916-2579    hali1@hfhs.org   
United States, Missouri
Cornell-Beshore Cancer Institute Recruiting
Joplin, Missouri, United States, 64804
Contact: Principal Investigator    417-347-4000    kjwilliams-wuch@freemanhealth.com   
Saint Luke's Cancer Institute Recruiting
Kansas City, Missouri, United States, 64111
Contact: Principal Investigator    816-932-3300    tpluard@saint-lukes.org   
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Principal Investigator    314-362-5740    haeseongpark@wustl.edu   
United States, New York
North Shore Hematology Oncology Associates, PC Recruiting
East Setauket, New York, United States, 11733
Contact: Principal Investigator    631-675-5111    researchpi@nycancer.com   
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45267-0502
Contact: Principal Investigator    513-584-0436    charifm@ucmail.uc.edu   
The Ohio State University Recruiting
Columbus, Ohio, United States, 43235
Contact: Principal Investigator    614-293-0066    maryam.lustberg@osumc.edu   
Dayton Physicians, LLC Recruiting
Kettering, Ohio, United States, 45409
Contact: Principal Investigator    937-771-2422    cbane@precisioncancerresearch.com   
United States, Pennsylvania
Abramson Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Principal Investigator    215-829-6088    davidmintzer@pennoncology.com   
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Principal Investigator    412-359-6147    jane.raymond@ahn.org   
UPMC Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Principal Investigator    412-641-6500    brufskyam@upmc.edu   
United States, Tennessee
The West Clinic Recruiting
Germantown, Tennessee, United States, 38138
Contact: Principal Investigator    650-724-6467    gvidal@westclinic.com   
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-8857
Contact: Principal Investigator    214-648-1906    barbara.haley@utsouthwestern.edu   
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Principal Investigator    713-792-8754    rmurthy1@mdanderson.org   
The Methodist Hospital Research Institute Recruiting
Houston, Texas, United States, 77030
Contact: Principal Investigator    713-441-9948    pniravath@houstonmethodist.org   
The University of Texas Health Science Center at Tyler Recruiting
Tyler, Texas, United States, 75708
Contact: Principal Investigator    903-877-7753    kamran.shahid@uthct.edu   
United States, Utah
Community Cancer Trials of Utah Recruiting
Ogden, Utah, United States, 84405
Contact: Principal Investigator    801-689-3909    nua2@outlook.com   
United States, Virginia
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Contact: Principal Investigator    703-528-7303    neelima.denduluri@usoncology.com   
United States, Washington
MultiCare Health System Institute for Research and Innovation Recruiting
Tacoma, Washington, United States, 98405
Contact: Principal Investigator    253-403-3321    anu.belur@multicare.org   
Australia, New South Wales
St Vincent's Hospital Sydney Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Principal Investigator    +61293555735    elgene.lim@svha.org.au   
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 2170
Contact: Principal Investigator    +61287389839    eugene.moylan@sswahs.nsw.gov.au   
Macquarie University Hospital Recruiting
Sydney, New South Wales, Australia, 2109
Contact: Principal Investigator    +61298123519    richard.kefford@mq.edu.au   
Australia, Queensland
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: Principal Investigator    +61731762111    katharine_cuff@health.qld.gov.au   
Australia, Victoria
Peninsula and South Eastern Haematology & Oncology Group Recruiting
Frankston, Victoria, Australia, 3199
Contact: Principal Investigator    +61 397815422    vg@poc.com.au   
Austin Health Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Principal Investigator    +61394965000    whitesh1@gmail.com   
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Contact: Principal Investigator    +61396563642    sherene.loi@petermac.org   
Sunshine Hospital Recruiting
Saint Albans, Victoria, Australia, 3021
Contact: Principal Investigator    +61383456666    catherine.oakman@wh.org.au   
Australia, Western Australia
St John of God Subiaco Hospital Recruiting
Subiaco, Western Australia, Australia, 6008
Contact: Principal Investigator    +61893661923    daphne@oncowest.com.au   
Belgium
Universitair Ziekenhuis Brussel Recruiting
Bruxelles, Belgium, 1090
Contact: Principal Investigator    +3224776415    christel.fontaine@uzbrussel.be   
AZ Maria Middelares Recruiting
Gent, Belgium, 9000
Contact: Principal Investigator    +3292468950    christof.vulsteke@azmmsj.be   
Az Groeninge Recruiting
Kortrijk, Belgium, 8500
Contact: Principal Investigator    +3251236111    marianne.hanssens@azgroeninge.be   
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Principal Investigator    +3216346903    hans.wildiers@uzleuven.be   
CHU UCL Namur site de Sainte Elisabeth Recruiting
Namur, Belgium, 5000
Contact: Principal Investigator    +3281720547    peter.vuylsteke@cmsenamur.be   
Brazil
Clínica de Neoplasias Litoral Ltda. Recruiting
Itajaí, Santa Catarina, Brazil, 88301-220
Contact: Principal Investigator    +554733485093    giuliano_borges@yahoo.com.br   
COI - Clínicas Oncológicas Integradas Recruiting
Rio De Janeiro, Brazil, 22793-080
Contact: Principal Investigator    +552135092114    gustavobuscacio@americasoncologia.com.br   
A. C. Camargo Cancer Center Recruiting
São Paulo, Brazil, 01509-900
Contact: Principal Investigator    +551132725166    jplima.onco@gmail.com   
Czechia
Fakultni nemocnice Brno Recruiting
Brno, Czechia, 625 00
Contact: Principal Investigator    +420532223642    kral.zdenek@fnbrno.cz   
Fakultni nemocnice v Motole Recruiting
Prague 5, Czechia, 150 06
Contact: Principal Investigator    +420224434700    jana.prausova@fnmotol.cz   
Nemocnice Na Bulovce Recruiting
Praha, Czechia, 180 81
Contact: Principal Investigator    +420266084516    petra.holeckova@bulovka.cz   
France
Hôpital Nord - CHU Marseille Recruiting
Marseille cedex 20, Bouches-du-Rhône, France, 13915
Contact: Principal Investigator    +33491965901    marjorie.baciuchka@ap-hm.fr   
Centre François Baclesse Recruiting
Caen Cedex 05, Calvados, France, 14076
Contact: Principal Investigator    +3331455050    c.levy@baclesse.unicancer.fr   
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie Recruiting
Plérin, Cotes d'Armor, France, 22190
Contact: Principal Investigator    +33296752216    ac.hardy@cario-sante.fr   
CHU Besançon - Hôpital Jean Minjoz Recruiting
Besançon, Doubs, France, 25030
Contact: Principal Investigator    +33 381479999    elsa.curtit@gmail.com   
Hôpital Privé d'Antony Recruiting
Antony, Hauts De Seine, France, 92160
Contact: Principal Investigator    +33 146252168    jgachet@hotmail.fr   
Centre René Huguenin Recruiting
Saint-Cloud, Hauts De Seine, France, 92110
Contact: Principal Investigator    +33144324680    jean-yves.pierga@curie.fr   
Institut Régional du Cancer de Montpellier Recruiting
Montpellier, Herault, France, 34298
Contact: Principal Investigator    +33 467612344    william.jacot@icm.unicancer.fr   
CRLCC Eugene Marquis Recruiting
Rennes cedex, Ille Et Vilaine, France, 35042
Contact: Principal Investigator    +33299253178    c.perrin@rennes.unicancer.fr   
Centre Oscar Lambret Recruiting
Lille cedex, Nord, France, 59020
Contact: Principal Investigator    +33320295959    e-kaczmarek@o-lambret.fr   
Institut Curie - site de Paris Recruiting
Paris Cedex 05, Paris, France, 75005
Contact: Principal Investigator    +33 144324680    jean-yves.pierga@curie.fr   
Centre Hospitalier de la côte Basque Recruiting
Bayonne Cedex, Pyrenees Atlantiques, France, 64109
Contact: Principal Investigator    +33 549444886    fminne@ch-cotebasque.fr   
Centre Hospitalier Lyon Sud Recruiting
Pierre Benite cedex, Rhone, France, 69495
Contact: Principal Investigator    +33478862339    nathalie.bonnin@chu-lyon.fr   
Clinique Victor Hugo - Centre Jean Bernard Recruiting
Le Mans Cedex 02, Sarthe, France, 72015
Contact: Principal Investigator    +33243297908    essaisbourgeois@i-l-c.fr   
Institut Sainte Catherine Recruiting
Avignon Cedex 9, Vaculuse, France, 84918
Contact: Principal Investigator    +33 149812459    j.grenier@isc84.org   
Institut Gustave Roussy Recruiting
Villejuif cedex, Val De Marne, France, 94805
Contact: Principal Investigator    +33142114370    fabrice.andre@gustaveroussy.fr   
Institut Régional du Cancer de Montpellier Recruiting
Montpellier, France, 34298
Contact: Principal Investigator    +33 467612344    william.jacot@icm.unicancer.fr   
Institut Curie - site de Paris Recruiting
Paris, France, 75005
Contact: Principal Investigator    +33 144324680    jean-yves.pierga@curie.fr   
Hopital Tenon Recruiting
Paris, France, 75020
Contact: Principal Investigator    +33156016024    joseph.gligorov@aphp.fr   
Greece
251 General Air Force Hospital Recruiting
Athens, Greece, 11525
Contact: Principal Investigator    +30 2107463806    nickkent10@yahoo.gr   
General Hospital of Athens "Alexandra" Recruiting
Athens, Greece, 11528
Contact: Principal Investigator    +30 2103381540    mdimop@med.uoa.gr   
General Oncology Hospital of Kifissia " Agioi Anargyroi" Recruiting
Athens, Greece, 14564
Contact: Principal Investigator    +30 2103015000    epsam@otenet.gr   
Euromedica General Clinic Thessaloniki Recruiting
Thessaloníki, Greece, 54645
Contact: Principal Investigator    +30 2310895362    konstantinos.papazisis@gmail.com   
Israel
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 9103102
Contact: Principal Investigator    +97235302988    shanips@szmc.org.il   
Hadassah University Hospital - Ein Kerem Recruiting
Jerusalem, Israel, 9112001
Contact: Principal Investigator    +97226777807    beatrice@hadassah.org.il   
Sapir Medical Center, Meir Hospital Recruiting
Kfar Saba, Israel, 4428164
Contact: Principal Investigator    +97297472836    bella.nisenbaum@clalit.org.il   
Rabin Medical Center-Beilinson Campus Recruiting
Petah tikva, Israel, 49100
Contact: Principal Investigator    +97239378098    rinaty@clalit.org.il   
Chaim Sheba Medical Center Recruiting
Ramat Gan, Israel, 52363
Contact: Principal Investigator    +97236973494    rinat.bernstein@sheba.health.gov.il   
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 6423906
Contact: Principal Investigator    +972504048522    amirsonn@gmail.com   
Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) Recruiting
Monza, Milano, Italy, 20900
Contact: Principal Investigator    +390392339037    marina.cazzaniga@asst-monza.it   
IRCCS Centro di Riferimento Oncologico Recruiting
Aviano, Pordenone, Italy, 33081
Contact: Principal Investigator    +390434659024    spazzapan@cro.it   
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) Recruiting
Bergamo, Italy, 24127
Contact: Principal Investigator    +39352674660    alberto.zambelli@hpg23.it   
Istituto Nazionale per la Ricerca sul Cancro di Genova Recruiting
Genova, Italy, 16132
Contact: Principal Investigator    +390105558917    lucia.delmastro@hsanmartino.it   
Azienda Ospealiera della Provincia di Lecco Recruiting
Lecco, Italy, 23900
Contact: Principal Investigator    +39341489155    a.ardizzoia@asst-lecco.it   
Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte Recruiting
Messina, Italy, 98158
Contact: Principal Investigator    +39903996150    vadamo@unime.it; adamovi@libero.it   
Ospedale San Raffaele Recruiting
Milano, Italy, 20132
Contact: Principal Investigator    +390226436530    gianni.luca@hsr.it   
IEO Istituto Europeo di Oncologia Recruiting
Milano, Italy, 20141
Contact: Principal Investigator    +390257489970    marco.colleoni@ieo.it   
Istituto Nazionale Tumori Fondazione G. Pascale Recruiting
Napoli, Italy, 80131
Contact: Principal Investigator    +390817464286    delauren@unina.it   
Azienda Ospedaliero Universitaria di Parma Recruiting
Parma, Italy, 43100
Contact: Principal Investigator    +39521702314    amusolino@ao.pr.it   
Azienda Ospedaliera Città della Salute e della Scienza di Torino Recruiting
Torino, Italy, 10126
Contact: Principal Investigator    +390116334134    mairoldi@cittadellasalute.to.it   
Japan
Fukushima Medical University Hospital Recruiting
Fukushima-shi, Fukushima-Ken, Japan, 960-1295
Contact: See Central Contact         
Kindai University Hospital Recruiting
Osakasayama-shi, Osaka-Fu, Japan, 589-8511
Contact: See Central Contact         
Kindai University Hospital Recruiting
Ōsakasayama-shi, Osaka-Fu, Japan, 589-8511
Contact: See Central Contact    +81723660221    iwasa_t@med.kindai.ac.jp   
National Cancer Center Hospital Recruiting
Chuo Ku, Tokyo-To, Japan, 104-0045
Contact: See Central Contact         
NHO Shikoku Cancer Center Recruiting
Ehime, Japan, 791-0280
Contact: See Central Contact         
NHO Kyushu Cancer Center Recruiting
Fukuoka, Japan, 811-1395
Contact: See Central Contact         
Hiroshima City Hiroshima Citizens Hospital Recruiting
Hiroshima, Japan, 730-8518
Contact: See Central Contact         
NHO Hokkaido Cancer Center Recruiting
Hokkaido, Japan, 003-0804
Contact: See Central Contact         
Hyōgo College of Medicine Hospital Recruiting
Hyōgo, Japan, 663-8501
Contact: See Central Contact         
St. Marianna University School of Medicine Hospital Recruiting
Kanagawa, Japan, 216-8511
Contact: See Central Contact         
Kanagawa Cancer Center Recruiting
Kanagawa, Japan, 241-8515
Contact: See Central Contact         
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Contact: See Central Contact         
Tohoku University Hospital Recruiting
Miyagi, Japan, 980-8574
Contact: See Central Contact         
Aichi Cancer Center Hospital Recruiting
Nagoya, Japan, 464-8681
Contact: See Central Contact         
Niigata Cancer Center Hospital Recruiting
Niigata, Japan, 951-8566
Contact: See Central Contact         
Okayama University Hospital Recruiting
Okayama, Japan, 700-8558
Contact: See Central Contact         
NHO Osaka National Hospital Recruiting
Osaka, Japan, 540-0006
Contact: See Central Contact         
Osaka International Cancer Institute Recruiting
Osaka, Japan, 541-8567
Contact: See Central Contact         
Saitama Cancer Center Recruiting
Saitama, Japan, 362-0806
Contact: See Central Contact         
Shizuoka Cancer Center Recruiting
Shizuoka, Japan, 411-8777
Contact: See Central Contact         
Toranomon Hospital Recruiting
Tokyo, Japan, 105-8470
Contact: See Central Contact         
The Cancer Institute Hospital of JFCR Recruiting
Tokyo, Japan, 135-8550
Contact: See Central Contact         
Tokyo Medical University Hospital Recruiting
Tokyo, Japan, 160-0023
Contact: See Central Contact         
Korea, Republic of
Chungbuk National University Hospital Recruiting
Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
Contact: See Central Contact         
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Principal Investigator    +82317877022    jhkimmd@snu.ac.kr   
The Catholic University of Korea, St. Vincent's Hospital Recruiting
Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
Contact: See Central Contact         
Kyungpook National University Chilgok Hospital Recruiting
Daegu, Korea, Republic of, 41404
Contact: See Central Contact         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 02841
Contact: See Central Contact         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: See Central Contact         
Severance Hospital, Yonsei University Recruiting
Seoul, Korea, Republic of, 03772
Contact: See Central Contact         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: See Central Contact         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: See Central Contact         
Spain
ICO Badalona - Hospital Universitari Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Principal Investigator    +34934978925    vquiroga@iconcologia.net   
ICO l'Hospitalet - Hospital Duran i Reynals Recruiting
L'Hospitalet De Llobregat, Barcelona, Spain, 08908
Contact: Principal Investigator    +34932607331    silviavazquez@iconcologia.net   
Complejo Hospitalario Universitario A Coruña Recruiting
A Coruña, La Coruña, Spain, 15006
Contact: Principal Investigator    +34981178353    silviaantolin@hotmail.com   
Hospital Universitario de Canarias Recruiting
San Cristobal de la Laguna, Tenerife, Spain, 38320
Contact: Principal Investigator    +34922678000    jcruzjurado@gmail.com   
Hospital Infanta Cristina Recruiting
Badajoz, Spain, 06007
Contact: Principal Investigator    +34924218040 ext 48350    ignaciodelgadomingorance@gmail.com   
Hospital Quironsalud Barcelona Recruiting
Barcelona, Spain, 08023
Contact: Principal Investigator    +34932746085    josemanuel.perez@quironsalud.es   
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Principal Investigator    +34932275402    alprat@clinic.ub.es   
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain, 28007
Contact: Principal Investigator    +34913303508    mmartin@geicam.org   
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41009
Contact: Principal Investigator    +34 661256709    esteban.nogales@gmail.com   
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Contact: Principal Investigator    +34 955013068    ruizsabater@gmail.com   
Instituto Valenciano de Oncologia IVO Recruiting
Valencia, Spain, 46009
Contact: Principal Investigator    +34 961114050    jgavila@fivo.org   
Turkey
Adana Numune Training and Research Hospital Recruiting
Adana, Turkey, 01370
Contact: Principal Investigator    +9032235501014494    drtimucincil@gmail.com   
Akdeniz University Medical Faculty Recruiting
Antalya, Turkey, 07058
Contact: Principal Investigator    +905324872523    hs.coskun@yahoo.com   
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty Recruiting
Istanbul, Turkey, 34098
Contact: Principal Investigator    +905324167355    ozguroglu@gmail.com   
Medipol University Medical Faculty Recruiting
Istanbul, Turkey, 34214
Contact: Principal Investigator    +902124607777    omerfatih.olmez@medipol.com.tr   
Medical Park Goztepe Hospital Recruiting
Istanbul, Turkey, 34732
Contact: Principal Investigator    +902165423232    basakoven@yahoo.com   
Istanbul Medeniyet Uni Goztepe Training & Research Hospital Recruiting
Istanbul, Turkey, 34854
Contact: Principal Investigator    +9021245317005948    mgumus@superonline.com   
Kartal Lutfi Kirdar Research and Training Hospital Recruiting
Istanbul, Turkey, 34890
Contact: Principal Investigator    +902164583000    mehmetaliustaoglu@yahoo.com   
Izmir Medicalpark Hospital Recruiting
İzmir, Turkey, 35530
Contact: Principal Investigator    +902323995050    arslancagatay@yahoo.com   
Sakarya Traning and Research Hospital Recruiting
Sakarya, Turkey, 54187
Contact: Principal Investigator    +905054785576    ilhanhbo@hotmail.com   
Medical Park Samsun Hastanesi Recruiting
Samsun, Turkey, 55200
Contact: Principal Investigator    +903623114040    dilekgurgenyatagi@yahoo.com   
Namik Kemal University Recruiting
Tekirdağ, Turkey, 59100
Contact: Principal Investigator    +905059400839    tyetisyigit@nku.edu.tr   
United Kingdom
Royal Devon and Exeter Hospital (Wonford) Recruiting
Exeter, Devon, United Kingdom, EX2 5DW
Contact: Principal Investigator    +441392402118    peter.stephens4@nhs.net   
Derriford Hospital Recruiting
Plymouth, Devon, United Kingdom, PL6 8BQ
Contact: Principal Investigator    +44 1752202082    sdubey@nhs.net   
Aberdeen Royal Infirmary Recruiting
Aberdeen, Grampian Region, United Kingdom, AB25 2ZB
Contact: Principal Investigator    +441224553398    gurquhart@nhs.net   
Queen Mary University of London Recruiting
London, Greater London, United Kingdom, EC1M 6BQ
Contact: Principal Investigator    +442078828498    p.schmid@qmul.ac.uk   
University College London Hospitals Recruiting
London, Greater London, United Kingdom, NW1 2PG
Contact: Principal Investigator    +442034479072    r.roylance@nhs.net   
Sarah Cannon Research Institute UK Recruiting
London, Greater London, United Kingdom, W1G 6AD
Contact: Principal Investigator    +442032195251    tobias.arkenau@hcahealthcare.co.uk   
Western General Hospital Recruiting
Edinburgh, Lothian Region, United Kingdom, EH4 2XU
Contact: Principal Investigator    +441315372196    peter.hall@nhslothian.scot.nhs.uk   
Nottingham University Hospitals City Campus Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Contact: Principal Investigator    +44 1158231850    srinivasan.madhusudan@nottingham.ac.uk   
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Daiichi Sankyo Co., Ltd.
AstraZeneca
Investigators
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Study Director: Global Team Leader Daiichi Sankyo, Inc.

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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT03523585     History of Changes
Other Study ID Numbers: DS8201-A-U301
2018-000221-31 ( EudraCT Number )
184017 ( Registry Identifier: JAPIC CTI )
DESTINY-B02 ( Other Identifier: Daiichi Sankyo and AstraZeneca )
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daiichi Sankyo, Inc.:
Breast Cancer
Metastatic breast cancer
DS 8201a
DESTINY - Breast 02
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Trastuzumab
Lapatinib
Camptothecin
Immunoconjugates
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological
Protein Kinase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Immunologic Factors
Physiological Effects of Drugs