DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
NCT ID: NCT03523585
Last Updated: 2025-11-14
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
608 participants
INTERVENTIONAL
2018-08-01
2026-01-31
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
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
Capecitabine
Investigator's choice Standard of Care when combined with trastuzumab or lapatinib
Trastuzumab
Investigator's choice Standard of Care when combined with capecitabine
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
Capecitabine
Investigator's choice Standard of Care when combined with trastuzumab or lapatinib
Lapatinib
Investigator's choice Standard of Care when combined with capecitabine
Interventions
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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
Capecitabine
Investigator's choice Standard of Care when combined with trastuzumab or lapatinib
Lapatinib
Investigator's choice Standard of Care when combined with capecitabine
Trastuzumab
Investigator's choice Standard of Care when combined with capecitabine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
AstraZeneca
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Team Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Ironwood Cancer Research Centers
Chandler, Arizona, United States
UCLA Hematology Oncology - Main Site
Los Angeles, California, United States
Pacific Cancer Care
Monterey, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States
Washington Cancer Institute
Washington D.C., District of Columbia, United States
Florida Cancer Specialists-Broadway
Fort Myers, Florida, United States
Piedmont Cancer Institute, PC
Atlanta, Georgia, United States
Kapiolani Medical Center for Women and Children/Univ of HI
Honolulu, Hawaii, United States
Loyola University Health System
Maywood, Illinois, United States
Community Hospital
Munster, Indiana, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Maine Center for Cancer Medicine
Scarborough, Maine, United States
University of Maryland
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Cornell-Beshore Cancer Institute
Joplin, Missouri, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
North Shore Hematology Oncology Associates, PC
East Setauket, New York, United States
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Dayton Physicians, LLC
Kettering, Ohio, United States
Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States
Tennessee Oncology, PLLC Chattanooga
Chattanooga, Tennessee, United States
The West Clinic
Germantown, Tennessee, United States
SCRI - Tennessee Oncology
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
The University of Texas Health Science Center at Tyler
Tyler, Texas, United States
Community Cancer Trials of Utah
Ogden, Utah, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
MultiCare Health System Institute for Research and Innovation
Tacoma, Washington, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Macquarie University Hospital
Sydney, New South Wales, Australia
The Tweed Hospital
Tweed Heads, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Frankston Hospital
Frankston, Victoria, Australia
Peninsula and South Eastern Haematology & Oncology Group
Frankston, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Sunshine Hospital
Saint Albans, Victoria, Australia
South West Oncology
Warrnambool, Victoria, Australia
Ballarat Oncology & Haematology Service
Wendouree, Victoria, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia
Calvary North Adelaide Hospital
Bruce, , Australia
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
AZ Maria Middelares
Ghent, , Belgium
Az Groeninge
Kortrijk, , Belgium
UZ Leuven
Leuven, , Belgium
CHU UCL Namur site de Sainte Elisabeth
Namur, , Belgium
Pronutrir
Fortaleza, Ceará, Brazil
NOB - Núcleo de Oncologia da Bahia
Salvador, Estado de Bahia, Brazil
AMO - Assistência Multidisciplinar em Oncologia
Salvador, Estado de Bahia, Brazil
Oncobio Servicos de Saude
Nova Lima, Minas Gerais, Brazil
HGB - Hospital Giovanni Battista - Mãe de Deus Center
Porto Alegre, Rio Grande do Sul, Brazil
CliniOnco - Tratamento Integrado do Câncer
Porto Alegre, Rio Grande do Sul, Brazil
Escosteguy Barrios, Carlos Henrique
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, Brazil
Clínica de Neoplasias Litoral Ltda.
Itajaí, Santa Catarina, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, São Paulo, Brazil
IBCC - Instituto Brasileiro de Controle do Câncer
São Paulo, São Paulo, Brazil
COI - Clínicas Oncológicas Integradas
Rio de Janeiro, , Brazil
Sociedade Beneficiente de Senhoras Hospital Sírio Libanês
São Paulo, , Brazil
A. C. Camargo Cancer Center
São Paulo, , Brazil
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Nemocnice Na Bulovce
Prague, , Czechia
Hôpital Nord - CHU Marseille
Marseille, Bouches-du-Rhône, France
Centre François Baclesse
Caen, Calvados, France
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
Plérin, Cotes d'Armor, France
Centre Georges François Leclerc
Dijon, Côte-d'Or, France
CHU Besançon - Hôpital Jean Minjoz
Besançon, Doubs, France
CHU Brest - Hôpital Morvan
Brest, Finistere, France
Hôpital Privé d'Antony
Antony, Hauts De Seine, France
Centre René Huguenin
Saint-Cloud, Hauts De Seine, France
Clinique Clementville
Montpellier, Herault, France
Institut Régional du Cancer de Montpellier
Montpellier, Herault, France
CRLCC Eugene Marquis
Rennes, Ille Et Vilaine, France
Centre Oscar Lambret
Lille, Nord, France
Centre de cancerologie les Dentellieres
Valenciennes, Nord, France
Institut Curie - site de Paris
Paris, Paris, France
Centre Hospitalier de la côte Basque
Bayonne, Pyrenees Atlantiques, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhone, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, Sarthe, France
Centre Henri Becquerel
Rouen, Seine Maritime, France
Institut Sainte Catherine
Avignon, Vaculuse, France
Institut Gustave Roussy
Villejuif, Val De Marne, France
Institut Régional du Cancer de Montpellier
Montpellier, , France
Institut Curie - site de Paris
Paris, , France
Hopital Tenon
Paris, , France
Klinikum rechts der Isar der TU Muenchen
Munich, Bavaria, Germany
Marienhospital Bottrop gGmbH
Bottrop, Rhineland-Palatinate, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lübeck, Schleswig-Holstein, Germany
Helios-Kliniken Berlin-Buch
Berlin, , Germany
Kliniken Koeln
Cologne, , Germany
Universitaetsklinikum Duesseldorf AoeR
Düsseldorf, , Germany
Universitaetsklinikum Erlangen
Erlangen, , Germany
Universitaetsklinikum Leipzig AoeR
Leipzig, , Germany
Klinikum der Universitaet Muenchen - Campus Grosshardern
Munich, , Germany
Universitaetsklinikum Muenster
Müenster, , Germany
Haematologisch-Onkologische Schwerpunktpraxis
Troisdorf, , Germany
251 General Air Force Hospital
Athens, , Greece
General Hospital of Athens "Alexandra"
Athens, , Greece
General Oncology Hospital of Kifissia " Agioi Anargyroi"
Athens, , Greece
University General Hospital of Heraklion
Heraklion, , Greece
Euromedica General Clinic Thessaloniki
Thessaloniki, , Greece
Rambam Health Care Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Sapir Medical Center, Meir Hospital
Kfar Saba, , Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
Monza, Milano, Italy
IRCCS Centro di Riferimento Oncologico
Aviano, Pordenone, Italy
Ospedale Sacro Cuore Don Calabria
Negrar, Verona, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, , Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, , Italy
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
Cona, , Italy
Istituto Nazionale per la Ricerca sul Cancro di Genova
Genova, , Italy
Azienda Ospealiera della Provincia di Lecco
Lecco, , Italy
Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
Messina, , Italy
Ospedale San Raffaele
Milan, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
IEO Istituto Europeo di Oncologia
Milan, , Italy
A.O.U. Policlinico di Modena
Modena, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, , Italy
IOV - Istituto Oncologico Veneto IRCCS
Padua, , Italy
Azienda Ospedaliero Universitaria di Parma
Parma, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, , Italy
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, Japan
Kindai University Hospital
Ōsakasayama-shi, Osaka, Japan
National Cancer Center Hospital
Chūōku, Tokyo-To, Japan
NHO Shikoku Cancer Center
Ehime, , Japan
NHO Kyushu Cancer Center
Fukuoka, , Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, , Japan
NHO Hokkaido Cancer Center
Hokkaido, , Japan
Hyōgo College of Medicine Hospital
Hyōgo, , Japan
St. Marianna University School of Medicine Hospital
Kanagawa, , Japan
Kanagawa Cancer Center
Kanagawa, , Japan
Kyoto University Hospital
Kyoto, , Japan
Tohoku University Hospital
Miyagi, , Japan
Aichi Cancer Center Hospital
Nagoya, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Okayama University Hospital
Okayama, , Japan
NHO Osaka National Hospital
Osaka, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Saitama Cancer Center
Saitama, , Japan
Shizuoka Cancer Center
Shizuoka, , Japan
Toranomon Hospital
Tokyo, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Inha University Hospital
Incheon, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
National Cancer Center
Goyang-si, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de Especialidades de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, Spain
Hospital Infanta Cristina
Badajoz, , Spain
Hospital Quironsalud Barcelona
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitari Arnau de Vilanova
Lleida, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
MD Anderson Cancer Centre
Madrid, , Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Instituto Valenciano de Oncologia IVO
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Acibadem Adana Hospital
Adana, , Turkey (Türkiye)
Adana Numune Training and Research Hospital
Adana, , Turkey (Türkiye)
Ankara Yildirim Beyazit Uni. Med. Fac.Ankara City Hospital
Ankara, , Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, , Turkey (Türkiye)
Uludag University Medical Faculty
Bursa, , Turkey (Türkiye)
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital
Istanbul, , Turkey (Türkiye)
Medipol University Medical Faculty
Istanbul, , Turkey (Türkiye)
Medical Park Goztepe Hospital
Istanbul, , Turkey (Türkiye)
Istanbul Medeniyet Uni Goztepe Training & Research Hospital
Istanbul, , Turkey (Türkiye)
Kartal Lutfi Kirdar Research and Training Hospital
Istanbul, , Turkey (Türkiye)
Izmir Medicalpark Hospital
Izmir, , Turkey (Türkiye)
Konya Necmettin Erbakan University Meram Faculty of Medicine
Konya, , Turkey (Türkiye)
Sakarya Traning and Research Hospital
Sakarya, , Turkey (Türkiye)
Medical Park Samsun Hastanesi
Samsun, , Turkey (Türkiye)
Namik Kemal University
Tekirdağ, , Turkey (Türkiye)
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter, Devon, United Kingdom
Derriford Hospital
Plymouth, Devon, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Grampian Region, United Kingdom
Queen Mary University of London
London, Greater London, United Kingdom
University College London Hospitals
London, Greater London, United Kingdom
Sarah Cannon Research Institute UK
London, Greater London, United Kingdom
Western General Hospital
Edinburgh, Lothian Region, United Kingdom
Nottingham University Hospitals City Campus
Nottingham, Nottinghamshire, United Kingdom
Countries
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References
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Andre F, Hee Park Y, Kim SB, Takano T, Im SA, Borges G, Lima JP, Aksoy S, Gavila Gregori J, De Laurentiis M, Bianchini G, Roylance R, Miyoshi Y, Armstrong A, Sinha R, Ruiz Borrego M, Lim E, Ettl J, Yerushalmi R, Zagouri F, Duhoux FP, Fehm T, Gambhire D, Cathcart J, Wu C, Chu C, Egorov A, Krop I. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 May 27;401(10390):1773-1785. doi: 10.1016/S0140-6736(23)00725-0. Epub 2023 Apr 20.
Fehm T, Cottone F, Dunton K, Andre F, Krop I, Park YH, De Laurentiis M, Miyoshi Y, Armstrong A, Borrego MR, Yerushalmi R, Duhoux FP, Takano T, Lu W, Egorov A, Kim SB. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): patient-reported outcomes from a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2024 May;25(5):614-625. doi: 10.1016/S1470-2045(24)00128-1.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018-000221-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
184017
Identifier Type: REGISTRY
Identifier Source: secondary_id
DESTINY-Breast02
Identifier Type: OTHER
Identifier Source: secondary_id
DS8201-A-U301
Identifier Type: -
Identifier Source: org_study_id