A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)

May 14, 2026 updated by: Daiichi Sankyo

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy (DESTINY-Breast05)

Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will examine trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive primary BC who have residual invasive disease in breast or axillary lymph nodes with higher risk of recurrence, which includes patients who were inoperable at disease presentation or had pathological node-positive status after neoadjuvant therapy.

The primary objective is to compare invasive disease-free survival (IDFS) between T-DXd and T-DM1 treatment arms in this population. The key secondary objective of the study is to evaluate disease-free survival (DFS).

Study Type

Interventional

Enrollment (Estimated)

1600

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

Argentina
- - Buenos Aires, Argentina, B1884BBF
    - COIBA
  - Caba, Argentina, 1426
    - Instituto Alexander Fleming
  - San Juan, Argentina, 5400
    - Cer San Juan
- La Rioja Province
  - Capital, La Rioja Province, Argentina, 5300
    - Centro Oncologico Riojano Integral
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, 2000
    - Sanatorio Británico de Rosario
  - Rosario, Santa Fe Province, Argentina, S2000KZE, 2457
    - Instituto de Oncología de Rosario
Australia
- - Adelaide, Australia, 5000
    - Royal Adelaide Hospital
  - Camperdown, Australia, 2050
    - Chris O Brien Lifehouse
  - Clayton, Australia, 3168
    - Monash Health
  - Heidelberg, Australia, 3804
    - Austin Hospital- Olivia Newto-John Cancer and Wellness Centre
  - Melbourne, Australia, 3000
    - Peter MacCallum Cancer Centre
  - Nedlands, Australia, 6009
    - Breast Cancer Research Centre - WA
  - Saint Leonards, Australia, 2065
    - Genesis Care Northern Cancer
  - Subiaco, Australia, 2050
    - St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC)
  - Wollongong, Australia, 2500
    - Southern Medical Day Care Centre
Belgium
- - Brasschaat, Belgium, 2930
    - Algemeen Ziekenhuis AZ Klina - Borstkliniek
  - Brussels, Belgium, 1200
    - Cliniques Universitaires Saint-Luc
  - Brussels, Belgium, 1000
    - Institut Jules Bordet Brussels Belgium
  - Leuven, Belgium, 3000
    - UZ Leuven - Campus Gasthuisberg
  - Liège, Belgium, 4000
    - Chu Liege
  - Wilrijk, Belgium, 2610
    - GZA Hospitals Campus Sint- Augustinus
- Antwerpen
  - Edegem, Antwerpen, Belgium, 2650
    - Antwerp University Hospital
- O. VL.
  - Ghent, O. VL., Belgium, 9000
    - UZ Gent
Brazil
- - Rio de Janeiro, Brazil, 20560-120
    - INCA - Instituto Nacional do Cancer / Hospital do Cancer HCIII
  - São Paulo, Brazil, 01246-000
    - Instituto do Cancer do Estado de Sao Paulo (ICESP)
- Federal District
  - Brasília, Federal District, Brazil, 70200-730
    - Hospital Sirio-Libanes HSL - Centro de Oncologia - Brasilia
- Paraná
  - Curitiba, Paraná, Brazil, 81520-060
    - Hospital Erasto Gaertner
- Rio Grande do Sul
  - Caxias do Sul, Rio Grande do Sul, Brazil, 95070-560
    - Fundação Universidade de Caxias do Sul Instituto de Pesquisas em Saúde IPS-UCS
  - Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
    - Hospital Sao Lucas PUCRS
- São Paulo
  - Barretos, São Paulo, Brazil, 14784-400
    - Fundacao Pio XII-Hospital de Cancer de Barretos
  - Santo André, São Paulo, Brazil, 09060-650
    - CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
  - São José do Rio Preto, São Paulo, Brazil, 15092415
    - Hospital de Base de Sao Jose do Rio Preto
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N4N2
    - Tom Baker Cancer Centre
- Ontario
  - Ottawa, Ontario, Canada, K1H 8L6
    - The Ottawa Hospital Cancer Centre
- Quebec
  - Montreal, Quebec, Canada, H4A 3J1
    - McGill University Health Centre - Cedars Cancer Centre
  - Montreal, Quebec, Canada, H1T 2M4
    - CIUSSSS de l'Est-de-l'Ile-de-Montréal - Installation Hôpital Maisonneuve-Rosemont
  - Montreal, Quebec, Canada, H2X3E4
    - CHUM
  - Montreal, Quebec, Canada, H3T1E2
    - Jewish General Hospital Segal Cancer Centre
  - Québec, Quebec, Canada, G1S 4L8
    - CHU de Québec - Hôpital du Saint-Sacrement
Chile
- - Santiago, Chile, 7500921
    - Fundación Arturo López Pérez
  - Temuco, Chile, 4780000
    - SIM CRC
- RM
  - Santiago, RM, Chile, 8380456
    - Hospital Clínico Universidad de Chile
China
- - Beijing, China, 100191
    - Peking University Third Hospital
  - Beijing, China, 100142
    - Peking University Cancer Hospital
  - Changchun, China, 19512
    - Jilin University JLU - First Affiliated Hospital
  - Chengdu, China, 610041
    - Sichuan University - West China Hospital
  - Chongqing, China, 400016
    - Chongqing Medical University - The First Affiliated Hospital
  - Fuzhou, China, 35001
    - Union Hospital of Fujian Medical University
  - Guangzhou, China, 510030
    - Sun Yat-sen Memorial Hospital
  - Guangzhou, China, 510080
    - Guangdong Academy of Medical Science
  - Hangzhou, China, 310002
    - Zhejiang Cancer Hospital
  - Hangzhou, China, 310009
    - Second Affiliated Hospital of Zhejiang University
  - Harbin, China, 150060
    - Harbin Medical University Cancer Hospital
  - Jinan, China, 250117
    - Shandong Cancer Hospital
  - Nanchang, China, 330006
    - Nanchang University - The First Affiliated Hospital
  - Nanjing, China, 210029
    - Nanjing Medical University NMU - Jiangsu Province Hospital
  - Shanghai, China, 200032
    - Fudan University Cancer Hospital
  - Shijiazhuang, China, 50011
    - The 4th Hospital of Heibei Medical University
  - Xiamen, China, 361003
    - The First Affiliated Hospital of Xiamen University
Czechia
- - Brno, Czechia, 62500
    - University Hospital Brno
  - Prague, Czechia, 10034
    - Fakultni nemocnice Kralovske Vinohrady
Denmark
- - Aalborg, Denmark, 9000
    - Aalborg University Hospital
  - Aarhus, Denmark, 8210
    - Aarhus University Hospital
  - Copenhagen, Denmark, 2100
    - Rigshospitalet
  - Odense, Denmark, 5000
    - Odense University Hospital
  - Syddanmark, Denmark, 6400
    - Soenderborg Sygehus
France
- - Bordeaux, France, 33000
    - Institut Bergonie
  - Dijon, France, 21000
    - Centre Georges François Leclerc
  - La Roche-sur-Yon, France, 85925 cedex 9
    - CHD Vendée
  - La Tronche, France, 38700
    - Centre Hosp Univ de Grenoble CHUG
  - Lille, France, 59000
    - Centre Oscar Lambret
  - Lyon, France, 69008
    - Centre Leon Berard
  - Marseille, France, 13009
    - Institut Paoli-Calmettes
  - Montpellier, France, 34070
    - Centre de Cancérologie du Grand Montpellier
  - Nancy, France, 54000
    - The Sel of Centre dOncologie de Gentilly
  - Nice, France, 6189
    - Centre Antoine Lacassagne
  - Paris, France, 75015
    - Hopital Georges Pompidou
  - Paris, France, 75010
    - Hospital St Louis
  - Paris, France, 75020
    - IUC AP-HP. Sorbonne Université, Hôpital Tenon
  - Poitiers, France, 86021
    - CHU de Poitiers
  - Rennes, France, 35042
    - Centre Eugène Marquis
  - Saint-Herblain, France, 44360
    - Institut de Cancérologie de l'Ouest
  - Strasbourg, France, 67033
    - Strasbourg Europe Cancer Institute
- Gironde
  - Bordeaux, Gironde, France, 33000
    - Clinique Tivoli Ducos - Centre dOncologie et de Radiotherapie a Bordeaux
- Haute Garonne
  - Toulouse, Haute Garonne, France, 31059
    - Institut Claudius Regaud
- Lorraine
  - Metz, Lorraine, France, 57085
    - CHR Metz-Thionville
- Pays de la Loire Region
  - Saint-Priest-en-Jarez, Pays de la Loire Region, France, 42270
    - Institut de Cancerologie de La Loire
Germany
- - Augsburg, Germany, 86150
    - Gemeinschaftspraxis Dres. Halder / Bangerter
  - Berlin, Germany, 13125
    - Helios Klinikum Berlin-Buch
  - Berlin, Germany, 10117
    - Cahrité Campus Mitte
  - Berlin, Germany, 10317
    - Praxis Dr. med. J. Schilling
  - Berlin, Germany, 10367
    - MediOnko-Institut GbR, Praxisklinik Krebsheilkunde
  - Berlin, Germany, 12559
    - DRK Kliniken Berlin Köpenick
  - Berlin, Germany, 13349
    - Onkologische Schwerpunktpraxis
  - Bielefeld, Germany, 13349
    - Onkologische Schwerpunktpraxis
  - Braunschweig, Germany, 38108
    - Studien GbR Braunschweig
  - Bremen, Germany, 28205
    - Klinikum Bremen Mitte
  - Bremen, Germany, 28239
    - Frauenklinik DIAKO Bremen
  - Böblingen, Germany, 71065
    - Klinikverbund Südwest Kliniken Böblingen Frauenklinik Böblingen
  - Chemnitz, Germany, 09116
    - Klinikum Chemnitz gGmbH
  - Cologne, Germany, 50931
    - Unifrauenklinik Köln - Studienzentrum Gynäkologie
  - Cologne, Germany, 50935
    - St. Elisabeth Hospital
  - Cologne, Germany, 51067
    - Kliniken der Stadt Köln / Brustzentrum Holweide
  - Deggendorf, Germany, 94469
    - DONAUISAR Klinikum
  - Dortmund, Germany, 44137
    - Klinikum Dortmund gGmbH
  - Dortmund, Germany, 44137
    - St.-Johannes-Hospital Dortmund, Dept. of Obstetrics/Gynecology
  - Dresden, Germany, 01067
    - Onkologische Schwerpunktpraxis
  - Dresden, Germany, 01069
    - University Hospital Dresden
  - Dresden, Germany, 01127
    - Onkozentrum Dresden
  - Düsseldorf, Germany, 40225
    - Universitätsklinikum Düsseldorf, Klinik für Frauenheilkunde & Geburtshilfe
  - Erlangen, Germany, 91054
    - Frauenklinik der Universität Erlangen
  - Essen, Germany, 45136
    - Kliniken Essen-Mitte, Klinik für Senologie/ Interdisziplinäres Brustzentrum
  - Essen, Germany, 45147
    - Universitätsklinikum Essen, Frauenklinik
  - Esslingen am Neckar, Germany, 73730
    - Klinikum Esslingen GmbH
  - Frankfurt, Germany, 60323
    - Frankfurt University Department of Gynecology and Obstetrics
  - Frankfurt am Main, Germany, 60431
    - Agaplesion Markus Krankenhaus
  - Frankurt Am Main, Germany, 60389
    - Centrum for Haematology and Oncology
  - Freiburg im Breisgau, Germany, 79106
    - Universitätsklinik Freiburg, Klinik für Frauenheilkunde
  - Gelsenkirchen, Germany, 45879
    - Evangelische Kliniken Gelsenkirchen
  - Georgsmarienhütte, Germany, 49074
    - MVZ II der Niels-Stensen-Kliniken
  - Gera, Germany, 07548
    - SRH Waldklinikum Gera, Brustzentrum Ostthüringen
  - Goslar, Germany, 38642
    - MVZ Onkologische Kooperation Harz
  - Halle, Germany, 06110
    - Krankenhaus St. Elisabeth und St. Barbara Halle/Saale
  - Hamburg, Germany, 22457
    - Albertinen Krankenhaus
  - Hamburg, Germany, 20357
    - Mammazentrum HH am Krankenhaus Jerusalem
  - Hamburg, Germany, 20251
    - University Medical Center
  - Hanover, Germany, 30177
    - Gynäkologisch-Ontologische Praxis Hannover
  - Hanover, Germany, 30559
    - DIAKOVERE Henriettenstift Frauenklinik
  - Hildesheim, Germany, 31134
    - Gemeinschaftspraxis Frauenärzte am Bahnhofsplatz
  - Homburg, Germany, 66424
    - Department of Gyencology and Obstetrics, Saarland University Hospital
  - Karlsruhe, Germany, 76199
    - Vidia Christliche Kliniken Karlsruhe
  - Kassel, Germany, 34125
    - Klinikum Kassel
  - Kassel, Germany, 34117
    - Elisabethkrankenhaus Kassel, Brustzentrum
  - Kiel, Germany, 24105
    - University Hospital Schleswig-Holstein
  - Koblenz, Germany, 56068
    - Institut Für Versorgungsforschung in Der Onkologie
  - Limburg, Germany, 65549
    - St. Vincenz KH Limburg
  - Lübeck, Germany, 23562
    - Uksh Campus Lubeck
  - Magdeburg, Germany, 69120
    - Universitäts-Frauenklinik
  - Mainz, Germany, 55131
    - Department of Obstetrics and Gynecology
  - Mannheim, Germany, 68167
    - Medzinische Fakultät Mannheim, Universität Heidelberg
  - Memmingen, Germany, 87700
    - Klinikum Memmingen
  - Minden, Germany, 32429
    - Johannes Wesling Klinikum Minden, Hämatologie-Onkologie/Brustzentrum
  - Munich, Germany, 81925
    - Gynaekologie Arabella
  - Mönchengladbach, Germany, 41061
    - Brustzentrum Niederrhein
  - München, Germany, 80639
    - Medizinisches Versorgungszentrum für Hämatologie und Onkologie München MVZ GmbH
  - München, Germany, 81377
    - LMU Klinikum/ Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
  - München, Germany, 80637
    - Rotkreuzklinikum München, Frauenklinik
  - Neuss, Germany, 41462
    - Dept. OB/GYN Johanna Etienne Krankenhaus
  - Offenburg, Germany, 77694
    - Ortenau Klinikum Offenburg-Kehl
  - Oldenburg, Germany, 26133
    - Klinikum Oldenburg AöR
  - Paderborn, Germany, 33098
    - Frauenklinik St. Louise - St. Vincenz- Krankenhaus GmbH
  - Potsdam, Germany, 14467
    - Klinikum Ernst von Bergmann
  - Ravensburg, Germany, 88212
    - Studienzentrum Onkologie Ravensburg
  - Recklinghausen, Germany, 45659
    - Oncologianova GmbH
  - Rosenheim, Germany, 83022
    - RoMed Klinikum Rosenheim
  - Rostock, Germany, 18059
    - Univ-Hospital, Dept Ob/Gyn
  - Saarbrücken, Germany, 66113
    - CaritasKlinikum St. Theresia
  - Speyer, Germany, 67346
    - Onkologische Schwerpunktpraxis Speyer
  - Stralsund, Germany, 18435
    - G.SUND Gynäkologie Kompetenzzentrum
  - Torgau, Germany, 04860
    - KKH Torgau
  - Trier, Germany, 54290
    - Klinikum Mutterhaus
  - Troisdorf, Germany, 53840
    - Praxisnetzwerk Hämatologie/Internistische Onkologie
  - Tübingen, Germany, 91054
    - Frauenklinik
  - Ulm, Germany, 89081
    - Universitätsfrauenklinik Ulm
  - Villingen-Schwenningen, Germany, 78052
    - Schwarzwald - Baar Klinikum Frauenklinik
  - Wernigerode, Germany, 06484
    - Harzklinikum Dorothea Christiane Erxleben
  - Witten, Germany, 44649
    - St. Anna Hospital Brustzentrum
  - Worms, Germany, 67550
    - Klinikum Worms gGmbH
Greece
- - Pátrai, Greece, 26335
    - General Hospital of Patras Agios Andreas
- Attica
  - Athens, Attica, Greece, 11528
    - General Hospital of Athens Alexandra Clinic
  - Athens, Attica, Greece, 11528
    - Aretaieio Hospital
- Crete
  - Heraklion, Crete, Greece, 71110
    - University General Hospital of Heraklion
- West Greece
  - Pátrai, West Greece, Greece, 265 04
    - University General Hospital of Patras
Hong Kong
- - Hong Kong, Hong Kong, 10101
    - Pamela Youde Nethersole Eastern Hospital PYNEH
  - Hong Kong, Hong Kong, 999077
    - The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH)
  - Pok Fu Lam, Hong Kong, 10101
    - The University of Hong Kong (HKU) - Queen Mary Hospital (QMH)
Ireland
- - Cork, Ireland, T12 YN60
    - University College Cork
  - Dublin, Ireland, 7
    - Mater Misericordiae University Hospital
  - Limerick, Ireland, V94 F858
    - University Hospital Limerick
- IE-D
  - Dublin, IE-D, Ireland, 4
    - Saint Vincents University Hospital
- Leinster
  - Dublin, Leinster, Ireland, D8
    - St. James Hospital
Israel
- - Jerusalem, Israel, 91120
    - Hadassah Medical Center
  - Petah Tikva, Israel, 49100
    - Rabin Medical Center
- Southern District
  - Beersheba, Southern District, Israel, 8410101
    - Soroka MC
- Tel Aviv
  - Ramat Gan, Tel Aviv, Israel, 5262100
    - Sheba Medical Center
Italy
- - Ancona, Italy, 60126
    - Clinica Oncologica, Ospedali Riuniti Umberto 1
  - Aviano, Italy, 33081
    - Centro di Riferimento Oncologico di Aviano - SOC Oncologia Medica e Prevenzione Oncologica
  - Bari, Italy, 70124
    - Istituto Oncologico di Bari
  - Belluno, Italy, 32100
    - Azienda ULSS n. 1 Dolomiti
  - Bologna, Italy, 40138
    - Policlinico S.Orsola-Malpighi SSD Oncologia Medica Addarii
  - Bologna, Italy, 40138
    - SSD Oncologia Medica
  - Brindisi, Italy, 72100
    - Presidio Ospedaliero di Summa - Antonio Perrino
  - Candiolo, Italy, 10060
    - Istituto di Candiolo - IRCCS
  - Genova, Italy, 16132
    - Ospedale Poli SAN MARTINO
  - Grosseto, Italy, 58100
    - Area Vasta Sud Est Sede Operativa Grosseto
  - Grosseto, Italy, 58100
    - Azienda Usl Toscana sud est
  - Milan, Italy, 20132
    - Irccs Ospedale San Raffaele
  - Modena, Italy, 41122
    - University Hospital of Modena
  - Naples, Italy, 80131
    - INT Fondazione Pascale
  - Padova, Italy, 35128
    - Istituto Oncologico Veneto IRCCS
  - Pavia, Italy, 27100
    - ICS Maugeri IRCCS
  - Perugia, Italy, 06132
    - Azienda Ospedaliera di Perugia
  - Torino, Italy, 10126
    - A.O.U. Città della Salute e Della Scienza di Torino
- CT
  - Catania, CT, Italy, 95122
    - Azienda Ospedaliera Garibaldi-Nesima
- MI
  - Milan, MI, Italy, 20141
    - Istituto Europeo di Oncologia
Japan
- - Akashi, Japan, 673-8558
    - Hyogo Cancer Center
  - Chūōku, Japan, 104-0045
    - National Cancer Center (NCC) - Tsukiji Campus - National Cancer Center Hospital (NCCH)
  - Fukuoka, Japan, 811-1395
    - National Hospital Organization - National Kyushu Cancer Center
  - Hiroshima, Japan, 730-8518
    - Hiroshima City Hiroshima Citizens Hospital
  - Isehara, Japan, 253-0036
    - Tokai University Hospital - Isehara Campus
  - Kagoshima, Japan, 892-0833
    - Sagara Hospital
  - Kashiwa, Japan, 277-8577
    - National Cancer Center Hospital East (NCCHE) - Kashiwa Campus
  - Kyoto, Japan, 606-8507
    - Kyoto University Hospital
  - Kōtoku, Japan, 135-8550
    - Japanese Foundation for Cancer Research (JFCR) - The Cancer Institute Hospital - Breast Oncology Center
  - Matsuyama, Japan, 791-0280
    - National Hospital Organization (NHO) - Shikoku Cancer Center
  - Nagoya, Japan, 464-8681
    - Aichi Cancer Center Hospital
  - Niigata, Japan, 951-8133
    - Niigata Cancer Center Hospital
  - Nishinomiya, Japan, 663-8501
    - Hyogo Medical University Hospital
  - Okayama, Japan, 700-8558
    - Okayama University Hospital
  - Osaka, Japan, 540-0006
    - National Hospital Organization - Osaka National Hospital (ONH)
  - Osaka, Japan, 541-8567
    - Osaka International Cancer Institute (OICI)
  - Saitama, Japan, 362-0806
    - Saitama Cancer Center
  - Sakai, Japan, 590-0197
    - Kindai University (Kinki University) - Faculty of Medicine (Kinki University School of Medicine (KUSM)) - Kindai University Hospital (Kinki University Hospital) - Cancer Center
  - Sapporo, Japan, 003-0804
    - National Hospital Organization - Hokkaido Cancer Center
  - Sendai, Japan, 980-8574
    - Tohoku University Hospital (TUH) - Clinical Research, Innovation and Education Center (CRIETO)
  - Shinagawa-Ku, Japan, 1428666
    - Showa Medical University Hospital - Breast Center
  - Shinjuku-Ku, Japan, 160-0023
    - Tokyo Medical University Hospital
  - Shizuoka, Japan, 411-8777
    - Shizuoka Cancer Center (SCC)
  - Yokohama, Japan, 241-8515
    - Kanagawa Cancer Center Hospital - Kanagawa Cancer Center (Kanagawa Cancer Centre Research Institute)
Mexico
- Coahuila
  - Torreón, Coahuila, Mexico, 27000
    - CIMAB S.A. de C.V
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44280
    - Hospital Civil de Guadalajara Fray Antonio Alcalde
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64320
    - Consultorio del Dr. Joaqun Gabriel Reinoso Toledo
Netherlands
- - Breda, Netherlands, 4800 RK
    - Amphia Hospital Breda
  - Rotterdam, Netherlands, 3000 CA
    - Erasmus MC - Daniel den Hoed Oncologisch Centrum
- North Holland
  - Amsterdam, North Holland, Netherlands, 1081 HZ
    - Amsterdam UMC - VU Medisch Centrum
Peru
- - Lima, Peru, Lima 27
    - Clinica Ricardo Palma
  - Lima, Peru, 15082
    - Hospital Nacional Arzobispo Loayza
  - Lima, Peru, Lima 34
    - Instituto Nacional de Enfermedades Neoplasicas INEN
  - Trujillo, Peru, 13001
    - Centro de Investigacion Clinica Trujillo Eirl
Poland
- - Lodz, Poland, 93-338
    - Instytut Centrum Zdrowia Matki Polki
  - Warsaw, Poland, 02-781
    - MSCM Cancer Center and Institute of Oncology Department of Breast Cancer and Reconstructive Surgery
- Greater Poland Voivodeship
  - Poznan, Greater Poland Voivodeship, Poland, 61-485
    - Centrum Medyczne HCP Sp. z o.o.
- Opole Voivodeship
  - Opole, Opole Voivodeship, Poland, 45-061
    - SP Zoz Opolskie Centrum Onkologii IM
- Pomeranian Voivodeship
  - Gdansk, Pomeranian Voivodeship, Poland, 80-211
    - Uniwersyteckie Centrum Kliniczne
Portugal
- - Guimarães, Portugal, 4835-044
    - Hospital da Senhora da Oliveira, Guimarães EPE
  - Lisbon, Portugal, 1400-038
    - Fundação Champalimaud
  - Lisbon, Portugal, 1500-650
    - Hospital da Luz
  - Lisbon, Portugal, 1099-023
    - Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
  - Lisbon, Portugal, 1998-018
    - Hospital CUF Descobertas
  - Lisbon, Portugal, 1449-005
    - Centro Hospitalar de Lisboa Ocidental, EPE
  - Loures, Portugal, 2674-514
    - Hospital Beatriz Ângelo
  - Matosinhos Municipality, Portugal, 4464-513
    - Unidade Local de Saúde de Matosinhos, EPE
  - Porto, Portugal, 4200-072
    - Instituto Português de Oncologia do Porto Francisco Gentil, EPE
  - Vila Nova de Gaia, Portugal, 4434-502
    - Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
Romania
- - Bucharest, Romania, 22328
    - Institutul Oncologic Bucuresti IOB
- Cluj
  - Cluj-Napoca, Cluj, Romania, 400015
    - Institutul Oncologic Prof. Dr. Ion Chiricuta
- Dolj
  - Craiova, Dolj, Romania, 200103
    - Onco Clinic Consult SA
  - Craiova, Dolj, Romania, 200347
    - Centrul de Oncologie Sfantu Nectarie
Russia
- - Arkhangelsk, Russia, 163045
    - SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary
  - Sochi, Russia, 354057
    - State Budgetary Healthcare Institution Oncological Dispensary No. 2 of the Ministry of Health of Krasnodar Region
Singapore
- - Singapore, Singapore, 169610
    - National Cancer Center Singapore
  - Singapore, Singapore, 119074
    - National University Cancer Institute
South Korea
- - Daegu, South Korea, 41944
    - Kyungpook National University Hospital
  - Gyeonggi-do, South Korea, 13620
    - Seoul National University Bundang Hospital
  - Gyeonggi-do, South Korea, 10408
    - National Cancer Center
  - Gyeonggi-do, South Korea, 13496
    - CHA Bundang Medical Center CHA University
  - Incheon, South Korea, 21565
    - Gachon University Gil Medical Center
  - Irwon-dong, South Korea, 06351
    - Samsung Medical Center
  - Seoul, South Korea, 03080
    - Seoul National University Hospital
  - Seoul, South Korea, 03722
    - Severance Hospital
  - Seoul, South Korea, 02841
    - Korea University Anam Hospital
  - Songpa-gu, South Korea, 05505
    - Asan Medical Center
  - Yongsan, South Korea, 330-721
    - Soon Chun Hyang Central Medical Center (SCHMC)
Spain
- - A Coruña, Spain, 15006
    - Complejo Hospitalario Universitario A Coruña (CHUA)
  - Alcorcón, Spain, 28922
    - Hospital Universitario Fundacion Alcorcon
  - Alicante, Spain, 03010
    - Hospital General Universitario de Alicante
  - Alicante, Spain, 03550
    - Hospital de San Juan de Alicante
  - Badajoz, Spain
    - Hospital Universitario de Badajoz
  - Barcelona, Spain, 08003
    - Hospital del Mar
  - Barcelona, Spain, 08036
    - Hospital Clinic de Barcelona
  - Barcelona, Spain, 08035
    - Hospital Universitari Vall d'Hebron
  - Barcelona, Spain, 08221
    - Hospital Universitari Mutua Terrassa
  - Barcelona, Spain, 08304
    - Hospital de Mataró
  - Barcelona, Spain, 08023
    - IOB Institute Of Oncology-Hospital Quironsalud Barcelona
  - Barcelona, Spain, 08243
    - ALTHAIA, Xarxa Assistencial Universitària de Manresa F.P.
  - Barcelona, Spain, 08907
    - ICO Hospitalet
  - Barcelona, Spain, 2050
    - Ico Badalona
  - Castellon, Spain, 12002
    - Consorcio Hospitalario Provincial de Castelló
  - Cáceres, Spain, 10001
    - Hospital Universitario San Pedro de Alcántara
  - Girona, Spain, 17007
    - ICO Girona
  - Granada, Spain, 18016
    - Hospital Universitario Clínico San Cecilio
  - Jaén, Spain, 23007
    - Complejo Hospitalario de Jaen
  - León, Spain, 24001
    - Complejo Asistencial Universitario de Leon
  - Lleida, Spain, 25198
    - Hospital Arnau de Vilanova de Lleida
  - Madrid, Spain, 28034
    - Hospital Universitario Ramón y Cajal
  - Madrid, Spain, 28040
    - Hospital Universitario Fundacion Jimenez Diaz
  - Madrid, Spain, 28041
    - Hospital Universitario 12 de Octubre
  - Madrid, Spain, 28046
    - Hospital Universitario La Paz
  - Madrid, Spain, 28942
    - Hospital Universitario de Fuenlabrada
  - Madrid, Spain, 28222
    - Hospital Universitario Puerta de Hierro de Majadahonda
  - Madrid, Spain, 28033
    - Hospital MD Anderson Cancer Center Madrid
  - Madrid, Spain, 28027
    - Clínica Universidad de Navarra, Madrid
  - Madrid, Spain, 28050
    - HM Sanchinarro (CIOCC)
  - Madrid, Spain, 28938
    - Hospital Universitario HM Puerta del Sur
  - Murcia, Spain, 30008
    - Hospital General Universitario Morales Meseguer
  - Málaga, Spain, 29010
    - Hospital Universitario Virgen de la Victoria
  - Móstoles, Spain, 28933
    - Hospital Universitario Rey Juan Carlos
  - Navarro, Spain, 31008
    - Complejo Hospitalario de Navarra
  - Palma de Mallorca, Spain, 07198
    - Hospital Son Llatzer
  - Palma de Mallorca, Spain, 07120
    - Hospital Universitari Son Espases
  - San Cristóbal de La Laguna, Spain, 38320
    - Hospital Universitario de Canarias
  - Sant Cugat del Vallès, Spain, 08195
    - Hospital General de Catalunya
  - Santiago de Compostela, Spain, 15706
    - Complejo Hospitalario Clínico Universitario de Santiago de Compostela (CHUS)
  - Seville, Spain, 41009
    - Hospital Universitario Virgen Macarena
  - Seville, Spain, 41013
    - Hospital Quirón Salud Sagrado Corazón
  - Seville, Spain, 41013
    - Hospital Universtiario Virgen del Rocio
  - Valencia, Spain, 46010
    - Hospital Clinico Universitario de Valencia
  - Valencia, Spain, 46015
    - Hospital Arnau de Vilanova de Valencia
  - Valencia, Spain, 46009
    - Fundacion Instituto Valenciano de Oncologia (IVO)
  - Zaragoza, Spain, 50009
    - Hospital Clinico Universitario Lozano Blesa
- Bizkaia
  - Bilbao, Bizkaia, Spain, 48013
    - Hospital Universitario de Basurto
- Murcia
  - El Palmar, Murcia, Spain, 30120
    - Hospital Clinico Universitario Virgen de la Arrixaca
- Tarragona
  - Reus, Tarragona, Spain, 43204
    - Hospital Universitario Sant Joan Reus
Taiwan
- - Beitou, Taiwan, 112
    - Koo Foundation Sun Yat-Sen Cancer Center
  - Chang-hua, Taiwan, 50006
    - Changhua Christian Hospital (CCH)
  - Kaohsiung City, Taiwan, 80756
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
  - Taichung, Taiwan, 40447
    - China Medical University Hospital
  - Taichung, Taiwan, 40705
    - Taichung Veterans General Hospital
  - Tainan, Taiwan, 704
    - National Cheng Kung University Hospital
  - Tainan, Taiwan, 71004
    - Chi Mei Medical Center CMMC - Yongkang Branch
  - Taipei, Taiwan, 10449
    - Mackay Memorial Hospital
  - Taipei, Taiwan, 114
    - Tri-Service General Hospital
  - Taipei, Taiwan, 10002
    - National Taiwan University Hospital NTUH
  - Taipei, Taiwan, 111217
    - Taipei Veterans General Hospital TPVGH
  - Taipei, Taiwan, 33305
    - Chang Gung Memorial Hospital CGMH
- Yanchao District
  - Kaohsiung City, Yanchao District, Taiwan, 82445
    - E-Da Cancer Hospital
Turkey (Türkiye)
- - Edirne, Turkey (Türkiye), 22030
    - Trakya University Medical Faculty
  - Istanbul, Turkey (Türkiye), 34093
    - Istanbul Medeniyet University Medical Faculty
  - Izmir, Turkey (Türkiye), 35575
    - Medical Park - Izmir Hastanesi
- İç Anadolu
  - Ankara, İç Anadolu, Turkey (Türkiye), 6100
    - Hacettepe University Cancer Institute
United Kingdom
- - Bristol, United Kingdom, BS2 8ED
    - Univeristy Hospitals Bristol NHS Foundation Trust
  - Colchester, United Kingdom, CO4 5JL
    - Colchester Hospital, East Suffolk & North Essex NHS Foundation Trust
  - Exeter, United Kingdom, EX2 5DW
    - Royal Devon Exeter NHS Foundation Trust
  - Glasgow, United Kingdom, G12 0YN
    - Beatson West of Scotland Cancer Centre
  - London, United Kingdom, W6 8RF
    - Charing Cross Hospital
  - London, United Kingdom, SE1 9RT
    - Guys and St Thomas NHS Foundation Trust
  - Oxford, United Kingdom, OX3 7LJ
    - Oxford University Hospitals NHS Foundation Trust
  - Peterborough, United Kingdom, FY3 8NR
    - Blackpool Victoria Hospital
- Cambridgeshire
  - Peterborough, Cambridgeshire, United Kingdom, PE3 9NZ
    - Peterborough City Hospital
- Kent
  - Maidstone, Kent, United Kingdom, ME16 9QQ
    - Kent Oncology Centre Maidstone Hospital
- Lancashire
  - Manchester, Lancashire, United Kingdom, M20 4XB
    - The Christie Hospital
- Merseyside
  - Metropolitan Borough of Wirral, Merseyside, United Kingdom, CH63 4JY
    - Clatterbridge Cancer Centre
- Nottinghamshire
  - Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
    - Nottingham University Hospitals
- Somerset
  - Bath, Somerset, United Kingdom, BA1 3NG
    - Royal United Hospital Bath NHS Trust - Royal United Hospital RUH
  - Taunton, Somerset, United Kingdom, TA1 5DA
    - Somerset NHS Foundation Trust
- West Yorkshire
  - Leeds, West Yorkshire, United Kingdom, LS9 7TF
    - St. James University Hospital
United States
- California
  - Anaheim, California, United States, 92806
    - Kaiser Permanente
  - Anaheim, California, United States, 92801
    - The Oncology Institute of Hope & Innovation
  - Baldwin Park, California, United States, 91706
    - Kaiser Permanente
  - Bellflower, California, United States, 90706
    - Kaiser Permanente
  - Fontana, California, United States, 92335
    - Kaiser Permanente
  - Fountain Valley, California, United States, 92708
    - Orange Coast Blood and Cancer Care
  - Harbor City, California, United States, 90710
    - Kaiser Permanente
  - Irvine, California, United States, 92618
    - Kaiser Permanente
  - Long Beach, California, United States, 90806
    - Long Beach Memorial TCI
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente
  - Ontario, California, United States, 90710
    - Kaiser Permanente
  - Panorama City, California, United States, 91402
    - Kaiser Permanente
  - Riverside, California, United States, 92505
    - Kaiser Permanente
  - San Diego, California, United States, 92120
    - Kaiser Permanente
  - San Marcos, California, United States, 92078
    - Kaiser Permanente
  - West Los Angeles, California, United States, 90034
    - Kaiser Permanente
  - Woodland Hills, California, United States, 91367
    - Kaiser Permanente
- Florida
  - Altamonte Springs, Florida, United States, 32701
    - SCRI FCS North- Altamonte
  - Bonita Springs, Florida, United States, 34135
    - SCRI FCS South- Bonita
  - Brandon, Florida, United States, 33511
    - SCRI FCS North- Brandon Cancer Center
  - Cape Coral, Florida, United States, 33909
    - SCRI FCS South- North Fort Myers
  - Clearwater, Florida, United States, 33761
    - SCRI FCS North- Mease/Clearwater
  - Fort Myers, Florida, United States, 33901
    - SCRI FCS South
  - Fort Myers, Florida, United States, 33905
    - SCRI FCS South- Colonial
  - Fort Myers, Florida, United States, 33908
    - SCRI FCS South- Gladiolus
  - Gainesville, Florida, United States, 32605
    - SCRI FCS North- Gainesville Cancer Center
  - Jacksonville, Florida, United States, 32207
    - Baptist MD Anderson Cancer Center
  - Lady Lake, Florida, United States, 32159
    - SCRI FCS North- Villages East
  - Lakewood Rch, Florida, United States, 34211
    - SCRI FCS South- Lakewood Ranch
  - Largo, Florida, United States, 33770
    - SCRI FCS North- Largo/Highland
  - Lecanto, Florida, United States, 34461
    - SCRI FCS North- Lecanto
  - Naples, Florida, United States, 34102
    - SCRI FCS South- Naples West
  - Naples, Florida, United States, 34119
    - SCRI FCS South- Naples/Goodlette
  - New Port Richey, Florida, United States, 34655
    - SCRI FCS North- New Port Richey
  - Ocala, Florida, United States, 34474
    - SCRI FCS North- Ocala
  - Ocoee, Florida, United States, 34761
    - Orlando Health
  - Orange City, Florida, United States, 32763
    - SCRI FCS North- Orange City
  - Orlando, Florida, United States, 32806
    - Orlando Health
  - Orlando, Florida, United States, 32806
    - SCRI FCS North- Orlando Downtown
  - Port Charlotte, Florida, United States, 33980
    - SCRI FCS South- Port Charlotte
  - Sarasota, Florida, United States, 34232
    - SCRI FCS South- Sarasota-Cattleman
  - Sarasota, Florida, United States, 34236
    - SCRI FCS South-Sarasota-Downtown
  - Spring Hill, Florida, United States, 34608
    - SCRI FCS North- Spring Hill
  - St. Petersburg, Florida, United States, 33705
    - SCRI FCS North- St. Anthony's/St. Petersburg
  - St. Petersburg, Florida, United States, 33705
    - SCRI FCS North
  - Tampa, Florida, United States, 33607
    - SCRI FCS North- Tampa Cancer Center
  - Tavares, Florida, United States, 32778
    - SCRI FCS North- Tavares
  - Venice, Florida, United States, 34292
    - SCRI FCS South- Venice Healthpark
  - Weston, Florida, United States, 33326
    - Cleveland Clinic-Weston
  - Winter Park, Florida, United States, 32792
    - SCRI FCS North- Winter Park
- Illinois
  - Elmhurst, Illinois, United States, 60126
    - Elmhurst Memorial Hospital- Nancy W. Knowles Cancer Center
  - Naperville, Illinois, United States, 60540
    - Edward Cancer Center
  - Plainfield, Illinois, United States, 60585
    - Edward Cancer Center Plainfield
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky, Markey Cancer Center, Clinical Research Organization
  - Louisville, Kentucky, United States, 40207
    - Baptist Health Louisville
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Mary Bird Perkins Cancer Center
  - Baton Rouge, Louisiana, United States, 70805
    - LSU Health Baton Rouge North Clinic
  - Baton Rouge, Louisiana, United States, 70808
    - Our Lady of the Lake Physician Group-Medical Oncology
  - Covington, Louisiana, United States, 70433
    - Ochsner Hematology Oncology North Shore - Covington (West Region)
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Clinic Foundation
- Maryland
  - Baltimore, Maryland, United States, 21237
    - MedStar Franklin Square Medical Center-Harry and Jeanette Weinberg Cancer Institute
  - Baltimore, Maryland, United States, 21239
    - Medstar Franklin Square Cancer Center at Loch Raven Campus
  - Frederick, Maryland, United States, 21702
    - Frederick Health-James M Stockman Cancer Center
  - Silver Spring, Maryland, United States, 20910
    - Holy Cross Hospital
  - Silver Spring, Maryland, United States, 20904
    - Maryland Oncology Hematology
- New York
  - The Bronx, New York, United States, 10461
    - Montefiore Medical Center
- North Carolina
  - Cary, North Carolina, United States, 27518
    - Waverly Hematology Oncology
  - Rocky Mount, North Carolina, United States, 27804
    - UNC Cancer Care at Nash
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest Baptist Medical Center
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic - Hillcrest
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic-Fairview
  - Warrensville Heights, Ohio, United States, 44195
    - Cleveland Clinic South Pointe
- Pennsylvania
  - Bethel Park, Pennsylvania, United States, 15102
    - UPMC Upper St. Clair
  - Cranberry Township, Pennsylvania, United States, 16066
    - UPMC Passavant Cranberry/North
  - Erie, Pennsylvania, United States, 16505
    - UPMC Erie
  - Erie, Pennsylvania, United States, 16544
    - AHN Cancer Inst at St Vincent
  - Greensburg, Pennsylvania, United States, 15601
    - UPMC Arnold Palmer-Mt View
  - Harrisburg, Pennsylvania, United States, 17050
    - UPMC Pinnacle-Ortenzio Cancer Center
  - Harrisburg, Pennsylvania, United States, 17109
    - UMPC Pinnacle Pharmacy
  - Jefferson Hills, Pennsylvania, United States, 15025
    - AHN Cancer Insititute at Jefferson
  - Monroeville, Pennsylvania, United States, 15146
    - AHN Cancer Institute at Forbes
  - Monroeville, Pennsylvania, United States, 15146
    - UPMC Monroeville
  - Mount Pleasant, Pennsylvania, United States, 15666
    - UPMC Arnold Palmer-Mt Pleasant
  - N. Huntingdon, Pennsylvania, United States, 15642
    - UPMC Arnold Palmer-Norwin
  - Pittsburgh, Pennsylvania, United States, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, United States, 15232
    - UPMC Hillman Cancer Center
  - Pittsburgh, Pennsylvania, United States, 15215
    - UPMC St. Margaret
  - Pittsburgh, Pennsylvania, United States, 15213
    - Magee
  - Pittsburgh, Pennsylvania, United States, 15224
    - AHN Cancer Inst at West Penn
  - Pittsburgh, Pennsylvania, United States, 15237
    - UPMC Passavant HOA
  - Pittsburgh, Pennsylvania, United States, 15237
    - UPMC Passavant OHA
  - Uniontown, Pennsylvania, United States, 15401
    - UPMC Uniontown
  - Washington, Pennsylvania, United States, 15301
    - UPMC Washington
  - West Reading, Pennsylvania, United States, 19611
    - Reading Hospital, McGlinn Cancer Institute
  - Wexford, Pennsylvania, United States, 15090
    - AHN Cancer Institute at Wexford
  - York, Pennsylvania, United States, 17408
    - UPMC Pinnacle-Memorial Cancer Center
- Tennessee
  - Franklin, Tennessee, United States, 37067
    - SCRI TO Nashville- Franklin Tennessee Oncology, PLLC
  - Gallatin, Tennessee, United States, 37066
    - SCRI TO Nashville- Gallatin Tennessee Oncology, PLLC
  - Hendersonville, Tennessee, United States, 37075
    - SCRI TO Nashville- Hendersonville Tennessee Oncology, PLLC
  - Hermitage, Tennessee, United States, 37076
    - SCRI TO Nashville- Summit Tennessee Oncology, PLLC
  - Kingsport, Tennessee, United States, 37660
    - Regional Cancer Center at Indian Path Community Hospital
  - Lebanon, Tennessee, United States, 37090
    - SCRI TO Nashville- Lebanon Tennessee Oncology, PLLC
  - Nashville, Tennessee, United States, 37203
    - Tennessee Oncology Nashville / Sarah Cannon
  - Nashville, Tennessee, United States, 37203
    - SCRI TO Nashville- St. Thomas Midtown Tennessee Oncology, PLLC
  - Nashville, Tennessee, United States, 37205
    - SCRI TO Nashville- St. Thomas West Tennessee Oncology, PLLC
  - Nashville, Tennessee, United States, 37207
    - SCRI TO Nashville- Skyline Tennessee Oncology, PLLC
  - Nashville, Tennessee, United States, 37211
    - SCRI TO Nashville- Southern Hills Tennessee Oncology, PLLC
  - Smyrna, Tennessee, United States, 37167
    - SCRI TO Nashville- Smyrna Tennessee Oncology, PLLC
- Texas
  - Baytown, Texas, United States, 77521
    - Houston Methodist Baytown
  - Houston, Texas, United States, 77030
    - Houston Methodist
  - Houston, Texas, United States, 77070
    - Houston Methodist Willowbrook
  - Houston, Texas, United States, 77094
    - Houston Methodist West
  - Nassau Bay, Texas, United States, 77058
    - Houston Methodist Clear Lake
  - Sugar Land, Texas, United States, 77479
    - Houston Methodist Sugarland
  - The Woodlands, Texas, United States, 77385
    - Houston Methodist Woodlands
- Virginia
  - Bristol, Virginia, United States, 24201
    - Wellmont Medical Associates Oncology & Hematology
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia
  - Richmond, Virginia, United States, 23298
    - Virginia Commonwealth University Massey Cancer Center
- Washington
  - Auburn, Washington, United States, 98002
    - MultiCare Cancer Center Aurburn
  - Gig Harbor, Washington, United States, 98335
    - MultiCare Regional Cancer Center - Gig Harbor
  - Puyallup, Washington, United States, 98372
    - MultiCare Cancer Center Puyallup
  - Spokane, Washington, United States, 99204
    - MultiCare Institute for Research & Innovation
  - Spokane, Washington, United States, 99218
    - MultiCare Institute for Research & Innovation
  - Tacoma, Washington, United States, 98405
    - MultiCare Cancer Center Tacoma
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - West Virginia University

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

Description

Key Inclusion Criteria:

Adults ≥18 years old (local regulatory requirements will apply if the legal age of consent for study participation is >18 years old).
Pathologically documented HER2-positive breast cancer (BC):
- HER2-positive expression defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) confirmed prior to study randomization.
Histologically confirmed invasive breast carcinoma.
Clinical stage at disease presentation: T1-4, N0-3, M0; patients presenting with T1N0 tumors are not eligible.
Pathologic evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of neoadjuvant therapy meeting one of the following high-risk criteria:
- Inoperable breast cancer at presentation (prior to neoadjuvant therapy), defined as clinical stages T4, N0-3, M0 or T1-3, N2-3, M0.
- Operable at presentation, defined as clinical stages T1-3,N0-1,M0, with axillary node positive disease (ypN1-3) following neoadjuvant therapy.
Completion of neoadjuvant systemic therapy, including taxane-based chemotherapy and HER2-directed treatment prior to surgery.
- Systemic therapy must consist of at least 6 cycles of neoadjuvant therapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab (± pertuzumab) and at least 9 weeks of taxane-based chemotherapy to be completed prior to surgery. Patients may have received an anthracycline as part of neoadjuvant therapy in addition to taxane chemotherapy.
Adequate excision as confirmed per medical records: surgical removal of all clinically evident disease in the breast and axillary lymph nodes.
An interval of no more than 12 weeks between the date of last surgery and the date of randomization.
Known hormone receptor (HR) status, per local laboratory assessment, as defined by ASCO-CAP guidelines (≥1%): HR positive status defined by either positive estrogen receptor (ER) and/or positive progesterone receptor (PR).

status. HR-negative status defined by both known negative ER and known negative PR.

Left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to randomization.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening.
Has adequate organ function within 14 days before randomization.

Key Exclusion Criteria:

Stage IV (metastatic) BC.
History of any prior (ipsi- or contralateral) breast cancer except lobular carcinoma in situ (LCIS).
Evidence of clinically evident gross residual or recurrent disease following neoadjuvant therapy and surgery.
Prior treatment with T-DXd, T-DM1 or other anti-HER2 antibody-drug conjugate (ADC) or prior enrollment in a clinical study of T-DXd (regardless of treatment arm)
History of exposure to the following cumulative doses of anthracyclines:
- Doxorubicin > 240 mg/m^2
- Epirubicin or Liposomal Doxorubicin-Hydrochloride > 480 mg/m^2
- For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m^2
History of other malignancy within the last 5 years except for appropriately treated CIS of the cervix, nonmelanoma skin carcinoma, Stage I melanoma skin carcinoma, Stage I uterine cancer, or other appropriately treated non-breast malignancies with an outcome similar to those mentioned above.
History of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids and/or has ILD/pneumonitis noted on computed tomography (CT) scan of the chest at Screening (asymptomatic interstitial changes confined to recent radiation therapy fields are not excluded).
Known pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within three months prior to randomization, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease).
Any autoimmune, connective tissue or inflammatory disorders (eg, Rheumatoid arthritis, Sjogren's, sarcoidosis, etc) where there is documented or a suspicion of pulmonary involvement or pneumonectomy at the time of screening.
Medical history of myocardial infarction (MI) within 6 months before randomization, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), troponin levels consistent with MI as defined according to the manufacturer 28 days prior to randomization.

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)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trastuzumab deruxtecan (T-DXd) Participants who will be randomized to receive trastuzumab deruxtecan (T-DXd) at a starting dose of 5.4 mg/kg.	Drug: DS-8201a Administered initially as an intravenous (IV) infusion at a dose of 5.4 mg/kg on Day 1 of each 21-day cycle Other Names: Trastuzumab deruxtecan (T-DXd)
Active Comparator: Trastuzumab ematansine (T-DM1) Participants who will be randomized to receive trastuzumab ematansine (T-DM1) at a starting dose of 3.6 mg/kg.	Drug: T-DM1 Administered initially as an intravenous (IV) infusion at a dose of 3.6 mg/kg on Day 1 of each 21-day cycle Other Names: Trastuzumab emtansine (T-DM1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Invasive Disease-free Survival (IDFS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment Time Frame: Randomization to date of invasive local, axillary or distant recurrence, invasive contralateral breast cancer or death from any cause (whichever occurs first), up to approximately 57 months postdose	Randomization to date of invasive local, axillary or distant recurrence, invasive contralateral breast cancer or death from any cause (whichever occurs first), up to approximately 57 months postdose

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease-free Survival (DFS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment Time Frame: Randomization to date of the first occurrence of an IDFS event including second primary non-breast cancer event or contralateral or ipsilateral ductal carcinoma in situ (whichever occurs first), up to approximately 81 months postdose	Randomization to date of the first occurrence of an IDFS event including second primary non-breast cancer event or contralateral or ipsilateral ductal carcinoma in situ (whichever occurs first), up to approximately 81 months postdose
Overall Survival (OS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment Time Frame: Randomization to date of death from any cause, up to approximately 81 months postdose	Randomization to date of death from any cause, up to approximately 81 months postdose
Distant Recurrence-free Interval (DRFI) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment Time Frame: Randomization to date of distant recurrence, up to approximately 81 months postdose	Randomization to date of distant recurrence, up to approximately 81 months postdose
Brain Metastases-free Interval (BMFI) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment Time Frame: Randomization to date of brain metastasis, up to approximately 81 months postdose	Randomization to date of brain metastasis, up to approximately 81 months postdose
Percentage of Treatment-emergent Adverse Events in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment Time Frame: Baseline up to approximately 81 months postdose	Baseline up to approximately 81 months postdose
Serum Concentrations of Trastuzumab Deruxtecan (T-DXd), total anti-HER2 antibody, and Active Metabolite MAAA-1181a Time Frame: Pre-dose on Day 1 of Cycles 1, 4 and 10 and within 15 minutes post-dose on Day 1 of Cycles 1 and 4 (each cycle is 21 days)	Pre-dose on Day 1 of Cycles 1, 4 and 10 and within 15 minutes post-dose on Day 1 of Cycles 1 and 4 (each cycle is 21 days)
Percentage of Participants Positive for Treatment-emergent Anti-drug Antibodies (ADAs) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Time Frame: Baseline up to approximately 81 months postdose	Baseline up to approximately 81 months postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo

Collaborators

AstraZeneca

NSABP Foundation Inc

Spanish Breast Cancer Research Group (SOLTI)

GBG Forschungs GmbH

Investigators

Study Director: Global Clinical 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

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)

December 4, 2020

Primary Completion (Actual)

July 2, 2025

Study Completion (Estimated)

June 20, 2028

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (Actual)

November 9, 2020

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

DS8201-A-U305
2020-003982-20 (EudraCT Number)
DESTINY-Breast05 (Other Identifier: Daiichi Sankyo and AstraZeneca)
NSABP B-60 (Other Identifier: National Surgical Adjuvant Breast and Bowel Project (NSABP))
GBG-103 (Other Identifier: German Breast Group (GBG))
SOLTI-2001 (Other Identifier: Spanish Breast Cancer Research Group (SOLTI))

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

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.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

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Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

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Collaborators

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Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Clinical Trials on DS-8201a

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