DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
February 6, 2026 updated by: Daiichi Sankyo
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
Completed
Conditions
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bruce, Australia, 2614
- Calvary North Adelaide Hospital
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New South Wales
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Darlinghurst, New South Wales, Australia, 2010
- St Vincent's Hospital Sydney
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Liverpool, New South Wales, Australia, 2170
- Liverpool Hospital
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Sydney, New South Wales, Australia, 2109
- Macquarie University Hospital
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Tweed Heads, New South Wales, Australia, 2485
- The Tweed Hospital
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Queensland
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Woolloongabba, Queensland, Australia, 4102
- Princess Alexandra Hospital
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South Australia
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Kurralta Park, South Australia, Australia, 5037
- Ashford Cancer Centre Research
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Victoria
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Box Hill, Victoria, Australia, 3128
- Box Hill Hospital
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Frankston, Victoria, Australia, 3199
- Frankston Hospital
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Frankston, Victoria, Australia, 3199
- Peninsula and South Eastern Haematology & Oncology Group
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Heidelberg, Victoria, Australia, 3084
- Austin Health
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Melbourne, Victoria, Australia, 3000
- Peter MacCallum Cancer Centre
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Saint Albans, Victoria, Australia, 3021
- Sunshine Hospital
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Warrnambool, Victoria, Australia, 3280
- South West Oncology
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Wendouree, Victoria, Australia, 3355
- Ballarat Oncology & Haematology Service
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Western Australia
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Subiaco, Western Australia, Australia, 6008
- St John of God Subiaco Hospital
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Brussels, Belgium, 1200
- Cliniques Universitaires Saint-Luc
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Brussels, Belgium, 1090
- Universitair Ziekenhuis Brussel
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Ghent, Belgium, 9000
- AZ Maria Middelares
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Kortrijk, Belgium, 8500
- AZ Groeninge
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Leuven, Belgium, 3000
- UZ Leuven
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Namur, Belgium, 5000
- CHU UCL Namur site de Sainte Elisabeth
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Rio de Janeiro, Brazil, 22793-080
- COI - Clínicas Oncológicas Integradas
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São Paulo, Brazil, 01509-900
- A. C. Camargo Cancer Center
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São Paulo, Brazil, 01308
- Sociedade Beneficiente de Senhoras Hospital Sírio Libanês
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Ceará
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Fortaleza, Ceará, Brazil, 60810-180
- Pronutrir
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Estado de Bahia
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Salvador, Estado de Bahia, Brazil, 40170-110
- Nob - Nucleo de Oncologia Da Bahia
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Salvador, Estado de Bahia, Brazil, 41950-640
- AMO - Assistência Multidisciplinar em Oncologia
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Minas Gerais
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Nova Lima, Minas Gerais, Brazil, 34000
- Oncobio Servicos de Saude
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
- Hospital Nossa Senhora da Conceicao
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Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
- Hgb - Hospital Giovanni Battista - Mae de Deus Center
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Porto Alegre, Rio Grande do Sul, Brazil, 90430-090
- CliniOnco - Tratamento Integrado do Câncer
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Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
- Escosteguy Barrios, Carlos Henrique
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Santa Catarina
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Itajaí, Santa Catarina, Brazil, 88301-220
- Clínica de Neoplasias Litoral Ltda.
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São Paulo
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Santo André, São Paulo, Brazil, 09060-650
- Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
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São Paulo, São Paulo, Brazil, 03102-002
- IBCC - Instituto Brasileiro de Controle do Câncer
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Brno, Czechia, 625 00
- Fakultní Nemocnice Brno
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Olomouc, Czechia, 775 20
- Fakultni nemocnice Olomouc
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Prague, Czechia, 150 06
- Fakultni nemocnice v Motole
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Prague, Czechia, 180 81
- Nemocnice Na Bulovce
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Montpellier, France, 34298
- Institut Regional du Cancer de Montpellier
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Paris, France, 75020
- Hôpital Tenon
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Paris, France, 75005
- Institut Curie - Site de Paris
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, France, 13915
- Hopital Nord - CHU Marseille
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Calvados
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Caen, Calvados, France, 14076
- Centre Francois Baclesse
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Cotes d'Armor
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Plérin, Cotes d'Armor, France, 22190
- CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
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Côte-d'Or
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Dijon, Côte-d'Or, France, 21079
- Centre Georges François Leclerc
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Doubs
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Besançon, Doubs, France, 25030
- CHU Besançon - Hôpital Jean Minjoz
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Finistere
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Brest, Finistere, France, 29609
- CHU Brest - Hôpital Morvan
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Hauts De Seine
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Antony, Hauts De Seine, France, 92160
- Hôpital Privé d'Antony
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Saint-Cloud, Hauts De Seine, France, 92110
- Centre René Huguenin
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Herault
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Montpellier, Herault, France, 34070
- Clinique Clementville
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Montpellier, Herault, France, 34298
- Institut Regional du Cancer de Montpellier
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Ille Et Vilaine
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Rennes, Ille Et Vilaine, France, 35042
- CRLCC Eugene Marquis
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Nord
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Lille, Nord, France, 59020
- Centre Oscar Lambret
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Valenciennes, Nord, France, 59300
- Centre de cancerologie Les Dentellieres
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Paris
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Paris, Paris, France, 75005
- Institut Curie - Site de Paris
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Pyrenees Atlantiques
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Bayonne, Pyrenees Atlantiques, France, 64109
- Centre Hospitalier de la Cote Basque
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Rhone
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Pierre-Bénite, Rhone, France, 69495
- Centre Hospitalier Lyon Sud
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Sarthe
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Le Mans, Sarthe, France, 72015
- Clinique Victor Hugo - Centre Jean Bernard
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Seine Maritime
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Rouen, Seine Maritime, France, 76038
- Centre Henri Becquerel
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Vaculuse
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Avignon, Vaculuse, France, 84918
- Institut Sainte Catherine
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Val De Marne
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Villejuif, Val De Marne, France, 94805
- Institut Gustave Roussy
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Berlin, Germany, 13125
- Helios-Kliniken Berlin-Buch
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Cologne, Germany, 51067
- Kliniken Koeln
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Düsseldorf, Germany, 40225
- Universitaetsklinikum Duesseldorf AoeR
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Erlangen, Germany, 91054
- Universitaetsklinikum Erlangen
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Leipzig, Germany, 04103
- Universitaetsklinikum Leipzig AoeR
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Munich, Germany, 81377
- Klinikum der Universitaet Muenchen - Campus Grosshardern
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Müenster, Germany, 48149
- Universitaetsklinikum Muenster
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Troisdorf, Germany, 53840
- Haematologisch-Onkologische Schwerpunktpraxis
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Bavaria
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Munich, Bavaria, Germany, 81675
- Klinikum rechts der Isar der TU Muenchen
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Rhineland-Palatinate
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Bottrop, Rhineland-Palatinate, Germany, 46236
- Marienhospital Bottrop gGmbH
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Germany, 23538
- Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
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Athens, Greece, 11525
- 251 General Air Force Hospital
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Athens, Greece, 11528
- General Hospital of Athens "Alexandra"
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Athens, Greece, 14564
- General Oncology Hospital of Kifissia " Agioi Anargyroi"
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Heraklion, Greece, 71110
- University General Hospital of Heraklion
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Thessaloniki, Greece, 54645
- Euromedica General Clinic Thessaloniki
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Haifa, Israel, 3109601
- Rambam Health Care Center
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Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center
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Jerusalem, Israel, 9112001
- Hadassah University Hospital - Ein Kerem
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Kfar Saba, Israel, 4428164
- Sapir Medical Center, Meir Hospital
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Petah Tikva, Israel, 49100
- Rabin Medical Center-Beilinson Campus
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Ramat Gan, Israel, 52363
- Chaim Sheba Medical Center
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Tel Aviv, Israel, 6423906
- Tel Aviv Sourasky Medical Center
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Bergamo, Italy, 24127
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
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Bologna, Italy, 40138
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
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Cona, Italy, 44124
- Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
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Genova, Italy, 16132
- Istituto Nazionale per la Ricerca sul Cancro di Genova
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Lecco, Italy, 23900
- Azienda Ospealiera della Provincia di Lecco
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Messina, Italy, 98158
- Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
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Milan, Italy, 20132
- Ospedale San Raffaele
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Milan, Italy, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Milan, Italy, 20141
- IEO Istituto Europeo di Oncologia
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Modena, Italy, 41124
- A.O.U. Policlinico di Modena
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Napoli, Italy, 80131
- Istituto Nazionale Tumori Fondazione G. Pascale
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Padua, Italy, 35128
- Iov - Istituto Oncologico Veneto Irccs
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Parma, Italy, 43100
- Azienda Ospedaliero Universitaria di Parma
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Pavia, Italy, 27100
- Fondazione IRCCS Policlinico San Matteo
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Pisa, Italy, 56126
- Azienda Ospedaliero Universitaria Pisana
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Torino, Italy, 10126
- Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
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Milano
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Monza, Milano, Italy, 20900
- Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
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Pordenone
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Aviano, Pordenone, Italy, 33081
- IRCCS Centro di Riferimento Oncologico
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Verona
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Negrar, Verona, Italy, 37024
- Ospedale Sacro Cuore Don Calabria
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Ehime, Japan, 791-0280
- NHO Shikoku Cancer Center
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Fukuoka, Japan, 811-1395
- NHO Kyushu Cancer Center
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Hiroshima, Japan, 730-8518
- Hiroshima City Hiroshima Citizens Hospital
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Hokkaido, Japan, 003-0804
- NHO Hokkaido Cancer Center
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Hyōgo, Japan, 663-8501
- Hyogo College of Medicine Hospital
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Kanagawa, Japan, 241-8515
- Kanagawa Cancer Center
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Kanagawa, Japan, 216-8511
- St. Marianna University School of Medicine Hospital
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Kyoto, Japan, 606-8507
- Kyoto University Hospital
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Miyagi, Japan, 980-8574
- Tohoku University Hospital
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Nagoya, Japan, 464-8681
- Aichi Cancer Center Hospital
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Niigata, Japan, 951-8566
- Niigata Cancer Center Hospital
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Okayama, Japan, 700-8558
- Okayama University Hospital
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Osaka, Japan, 541-8567
- Osaka International Cancer Institute
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Osaka, Japan, 540-0006
- NHO Osaka National Hospital
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Saitama, Japan, 362-0806
- Saitama Cancer Center
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Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center
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Tokyo, Japan, 160-0023
- Tokyo Medical University Hospital
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Tokyo, Japan, 135-8550
- The Cancer Institute Hospital of JFCR
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Tokyo, Japan, 105-8470
- Toranomon Hospital
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Fukushima
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Fukushima, Fukushima, Japan, 960-1295
- Fukushima Medical University Hospital
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Osaka
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Osakasayama-shi, Osaka, Japan, 589-8511
- Kindai University Hospital
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Ōsakasayama-shi, Osaka, Japan, 589-8511
- Kindai University Hospital
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Tokyo-To
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Chūōku, Tokyo-To, Japan, 104-0045
- National Cancer Center Hospital
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Daegu, South Korea, 41404
- Kyungpook National University Chilgok Hospital
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Goyang-si, South Korea, 10408
- National Cancer Center
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Seoul, South Korea, 03080
- Seoul National University Hospital
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Seoul, South Korea, 05505
- Asan Medical Center
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Seoul, South Korea, 06351
- Samsung Medical Center
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Seoul, South Korea, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, South Korea, 02841
- Korea University Anam Hospital
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Seoul, South Korea, 03772
- Severance Hospital, Yonsei University
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Gyeonggi-do
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Incheon, Gyeonggi-do, South Korea, 22332
- Inha University Hospital
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Seongnam-si, Gyeonggi-do, South Korea, 13620
- Seoul National University Bundang Hospital
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Suwon, Gyeonggi-do, South Korea, 16499
- Ajou University Hospital
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Suwon, Gyeonggi-do, South Korea, 16247
- The Catholic University Of Korea, St. Vincent's Hospital
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North Chungcheong
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Cheongju-si, North Chungcheong, South Korea, 28644
- Chungbuk National University Hospital
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Badajoz, Spain, 06007
- Hospital Infanta Cristina
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Barcelona, Spain, 08036
- Hospital Clínic de Barcelona
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Barcelona, Spain, 08035
- Hospital Universitari Vall d'Hebron
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Barcelona, Spain, 8003
- Hospital del Mar
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Barcelona, Spain, 08023
- Hospital Quironsalud Barcelona
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Lleida, Spain, 25198
- Hospital Universitari Arnau de Vilanova
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Madrid, Spain, 28007
- Hospital General Universitario Gregorio Marañón
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Madrid, Spain, 28040
- Hospital Universitario Clínico San Carlos
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Madrid, Spain, 28033
- MD Anderson Cancer Centre
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Málaga, Spain, 29010
- Hospital Clinico Universitario Virgen de la Victoria
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Salamanca, Spain, 37370
- Hospital Universitario de Salamanca
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Seville, Spain, 41013
- Hospital Universitario Virgen del Rocio
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Seville, Spain, 41009
- Hospital Universitario Virgen Macarena
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Valencia, Spain, 46009
- Instituto Valenciano de Oncologia IVO
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Zaragoza, Spain, 50009
- Hospital Universitario Miguel Servet
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Barcelona
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Badalona, Barcelona, Spain, 08916
- ICO Badalona - Hospital Universitari Germans Trias i Pujol
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L'Hospitalet de Llobregat, Barcelona, Spain, 08908
- ICO L'Hospitalet - Hospital Duran i Reynals
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Cádiz
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Jerez de la Frontera, Cádiz, Spain, 11407
- Hospital de Especialidades de Jerez de La Frontera
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La Coruña
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A Coruña, La Coruña, Spain, 15006
- Complejo Hospitalario Universitario A Coruna
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Tenerife
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San Cristóbal de La Laguna, Tenerife, Spain, 38320
- Hospital Universitario de Canarias
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Adana, Turkey (Türkiye), 01130
- Acibadem Adana Hospital
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Adana, Turkey (Türkiye), 01370
- Adana Numune Training and Research Hospital
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Ankara, Turkey (Türkiye), 6800
- Ankara Yildirim Beyazit Uni. Med. Fac.Ankara City Hospital
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Antalya, Turkey (Türkiye), 07058
- Akdeniz University Medical Faculty
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Bursa, Turkey (Türkiye), 16059
- Uludag University Medical Faculty
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Istanbul, Turkey (Türkiye), 34214
- Medipol University Medical Faculty
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Istanbul, Turkey (Türkiye), 34098
- Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
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Istanbul, Turkey (Türkiye), 34147
- Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital
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Istanbul, Turkey (Türkiye), 34732
- Medical Park Goztepe Hospital
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Istanbul, Turkey (Türkiye), 34854
- Istanbul Medeniyet Uni Goztepe Training & Research Hospital
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Istanbul, Turkey (Türkiye), 34890
- Kartal Lutfi Kirdar Research and Training Hospital
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Izmir, Turkey (Türkiye), 35530
- Izmir Medicalpark Hospital
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Konya, Turkey (Türkiye), 42080
- Konya Necmettin Erbakan University Meram Faculty of Medicine
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Sakarya, Turkey (Türkiye), 54187
- Sakarya Traning and Research Hospital
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Samsun, Turkey (Türkiye), 55200
- Medical Park Samsun Hastanesi
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Tekirdağ, Turkey (Türkiye), 59100
- Namik Kemal University
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Cornwall
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Truro, Cornwall, United Kingdom, TR1 3LJ
- Royal Cornwall Hospital
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Devon
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Exeter, Devon, United Kingdom, EX2 5DW
- Royal Devon and Exeter Hospital (Wonford)
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Plymouth, Devon, United Kingdom, PL6 8BQ
- Derriford Hospital
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Grampian Region
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Aberdeen, Grampian Region, United Kingdom, AB25 2ZB
- Aberdeen Royal Infirmary
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Greater London
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London, Greater London, United Kingdom, EC1M 6BQ
- Queen Mary University of London
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London, Greater London, United Kingdom, NW1 2PG
- University College London Hospitals
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London, Greater London, United Kingdom, W1G 6AD
- Sarah Cannon Research Institute UK
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Lothian Region
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Edinburgh, Lothian Region, United Kingdom, EH4 2XU
- Western General Hospital
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Nottinghamshire
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Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
- Nottingham University Hospitals City Campus
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Arizona
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Chandler, Arizona, United States, 85224
- Ironwood Cancer Research Centers
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California
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Los Angeles, California, United States, 90095
- UCLA Hematology Oncology - Main Site
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Monterey, California, United States, 93940
- Pacific Cancer Care
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San Diego, California, United States, 92123
- Sharp Memorial Hospital
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Whittier, California, United States, 90603
- Innovative Clinical Research Institute
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Connecticut
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New Haven, Connecticut, United States, 06510
- Smilow Cancer Hospital at Yale New Haven
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District of Columbia
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Washington D.C., District of Columbia, United States, 20010
- Washington Cancer Institute
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Florida
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Fort Myers, Florida, United States, 33901
- Florida Cancer Specialists-Broadway
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Georgia
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Atlanta, Georgia, United States, 30318
- Piedmont Cancer Institute, PC
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Hawaii
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Honolulu, Hawaii, United States, 96826
- Kapiolani Medical Center for Women and Children/Univ of HI
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Illinois
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Maywood, Illinois, United States, 60153
- Loyola University Health System
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Indiana
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Munster, Indiana, United States, 46321
- Community Hospital
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Kentucky
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Louisville, Kentucky, United States, 40207
- Norton Cancer Institute
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Maine
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Scarborough, Maine, United States, 04074
- Maine Center For Cancer Medicine
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Missouri
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Joplin, Missouri, United States, 64804
- Cornell-Beshore Cancer Institute
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Kansas City, Missouri, United States, 64111
- Saint Luke's Cancer Institute
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Kansas City, Missouri, United States, 64132
- Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC
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St Louis, Missouri, United States, 63110
- Washington University
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New York
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East Setauket, New York, United States, 11733
- North Shore Hematology Oncology Associates, PC
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
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Ohio
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Cincinnati, Ohio, United States, 45267
- University of Cincinnati Medical Center
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Main Campus
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Columbus, Ohio, United States, 43235
- The Ohio State University
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Kettering, Ohio, United States, 45409
- Dayton Physicians, LLC
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheny General Hospital
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Pittsburgh, Pennsylvania, United States, 15213
- UPMC Cancer Center
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Tennessee Oncology, PLLC Chattanooga
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Germantown, Tennessee, United States, 38138
- The West Clinic
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Nashville, Tennessee, United States, 37203
- SCRI - Tennessee Oncology
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Texas
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Dallas, Texas, United States, 75390
- UT Southwestern Medical Center
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Houston, Texas, United States, 77030
- The Methodist Hospital Research Institute
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Tyler, Texas, United States, 75708
- The University of Texas Health Science Center at Tyler
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Utah
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Ogden, Utah, United States, 84405
- Community Cancer Trials of Utah
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Virginia
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Fairfax, Virginia, United States, 22031
- Virginia Cancer Specialists, PC
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Washington
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Tacoma, Washington, United States, 98405
- MultiCare Health System Institute for Research and Innovation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- is unresectable or metastatic
- has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
- was previously treated with 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:
- 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males)
- 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)
- 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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
|
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:
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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
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Investigator's choice Standard of Care when combined with trastuzumab or lapatinib
Other Names:
Investigator's choice Standard of Care when combined with capecitabine
Other Names:
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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
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Investigator's choice Standard of Care when combined with trastuzumab or lapatinib
Other Names:
Investigator's choice Standard of Care when combined with capecitabine
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
Time Frame: Baseline up to 46 months postdose
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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.
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Baseline up to 46 months postdose
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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
Time Frame: Baseline up to 46 months postdose
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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.
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Baseline up to 46 months postdose
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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
Time Frame: Baseline up to 46 months postdose
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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.
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Baseline up to 46 months postdose
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Duration of Response (DoR) Based on BICR in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
Time Frame: Baseline up to 46 months postdose
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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.
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Baseline up to 46 months postdose
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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
Time Frame: Up to 46 months
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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.
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Up to 46 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Global Team Leader, Daiichi Sankyo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2018
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
December 23, 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)
February 27, 2026
Last Update Submitted That Met QC Criteria
February 6, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Skin Diseases
- Breast Diseases
- Skin and Connective Tissue Diseases
- Breast Neoplasms
- Amino Acids, Peptides, and Proteins
- Proteins
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Nucleic Acids, Nucleotides, and Nucleosides
- Antibodies, Monoclonal, Humanized
- Antibodies, Monoclonal
- Antibodies
- Immunoglobulins
- Immunoproteins
- Blood Proteins
- Serum Globulins
- Globulins
- Deoxycytidine
- Cytidine
- Pyrimidine Nucleosides
- Pyrimidines
- Nucleosides
- Uracil
- Pyrimidinones
- Deoxyribonucleosides
- Fluorouracil
- Quinazolines
- 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.