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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Trastuzumab deruxtecan; Drug: Capecitabine; Drug: Trastuzumab; Drug: Lapatinib

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 Type: Interventional
• Enrollment (Actual): 608
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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; T-DXd
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine	Progression-free survival (PFS) by BICR was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause.	Baseline up to 46 months postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine	Overall survival (OS) was defined as the time from the date of randomization to the date of death due to 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.	Baseline up to 46 months postdose
Percentage of Participants With Objective Response Rate (ORR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine	The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by BICR and investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on BICR and Investigator Assessment is reported.	Baseline up to 46 months postdose
Duration of Response (DoR) Based on BICR in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine	Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR in participants with confirmed CR/PR based on BICR and investigator assessment is reported.	Baseline up to 46 months postdose
Progression-Free Survival (PFS) Based on Investigator Assessment in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine	Progression-free survival (PFS) by investigator assessment was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause.	Up to 46 months

Collaborators and Investigators

• Sponsor: Daiichi Sankyo
• Collaborators: AstraZeneca; Daiichi Sankyo Co., Ltd.
• Investigators: Study Director: Global Team Leader, Daiichi Sankyo

Publications and helpful links

General Publications

• 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. Erratum In: Lancet. 2023 Dec 9;402(10418):2196. Lancet. 2024 Mar 9;403(10430):912.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): June 30, 2022
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; Metastatic breast cancer; DS 8201a; DESTINY - Breast 02
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Immunoconjugates; Tyrosine Kinase Inhibitors; Trastuzumab; Capecitabine; Lapatinib; Trastuzumab deruxtecan
• Other Study ID Numbers: DS8201-A-U301; 2018-000221-31 (EudraCT Number); 184017 (Registry Identifier: JAPIC CTI); DESTINY-Breast02 (Other Identifier: Daiichi Sankyo and AstraZeneca)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) on completed studies 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/
• IPD Sharing Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and 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.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No