DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
6 other identifiers
interventional
524
15 countries
164
Brief Summary
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Aug 2018
Typical duration for phase_3 breast-cancer
164 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2018
CompletedFirst Posted
Study publicly available on registry
May 18, 2018
CompletedStudy Start
First participant enrolled
August 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2021
CompletedResults Posted
Study results publicly available
April 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
CompletedOctober 21, 2025
October 1, 2025
2.8 years
April 13, 2018
March 7, 2022
October 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
Progression-free survival (PFS) by BICR was defined as the time from the date of enrollment 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. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
Up to 33 months (data cut-off)
Secondary Outcomes (4)
Overall Survival (OS) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
Up to 33 months (data cut-off)
Percentage of Participants With Objective Response Rate (ORR) Based on BICR and Investigator Assessment in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
Up to 33 months (data cut-off)
Duration of Response (DoR) Based on BICR and Investigator Assessment in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
Up to 33 months (data cut-off)
Progression-Free Survival (PFS) Based on Investigator Assessment in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
Up to 33 months (data cut-off)
Study Arms (2)
Trastuzumab deruxtecan (T-DXd)
EXPERIMENTALParticipants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
Ado-trastuzumab emtansine (T-DM1)
ACTIVE COMPARATORParticipants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.
Interventions
T-DXd is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously.
The treatment will be in accordance with the approved label.
Eligibility Criteria
You may qualify if:
- Must be competent and able to comprehend, sign, and date an Institutional Review Board (IRB) or Ethics Committee (EC) approved ICF before performance of any study-specific procedures or tests.
- Adults ≥18 y old. (Please follow local regulatory requirements if the legal age of consent for study participation is \>18 y old.)
- 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.23
- was previously treated with trastuzumab and taxane in the advanced/ metastatic setting or progressed within 6 mo after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane.
- Documented radiologic progression (during or after most recent treatment or within 6 mo after completing adjuvant therapy).
- Subjects must be HER2-positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, a fresh biopsy is required.
- Presence of at least 1 measurable lesion per modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1
You may not qualify if:
- Prior treatment with an anti-HER2 ADC (such as T-DM1) in the metastatic setting. Prior treatment in the adjuvant/neoadjuvant setting would be allowed if progression of disease did not occur within 12 mo of end of adjuvant therapy.
- Uncontrolled or significant cardiovascular disease, including any of the following:
- History of myocardial infarction within 6 mo before randomization;
- History of symptomatic congestive heart failure (New York Heart Association Class II to IV);
- Troponin levels consistent with myocardial infarction as defined according to the manufacturer within 28 d prior to randomization;
- Corrected QT interval (QTc) prolongation to \> 470 ms (females) or \>450 ms (male) based on average of Screening triplicate 12-lead ECG;
- LVEF \< 50% within 28 d prior to randomization
- Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
- Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
- Subjects with clinically inactive brain metastases may be included in the study.
- Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 wk must have elapsed between the end of whole brain radiotherapy and study enrollment.
- Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.
- History of severe hypersensitivity reactions to other mAbs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
- Daiichi Sankyo Co., Ltd.collaborator
- AstraZenecacollaborator
Study Sites (164)
UCLA Hematology Oncology
Los Angeles, California, 90095, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
University of California San Francisco
San Francisco, California, 94115, United States
Innovative Clinical Research Institute
Whittier, California, 90603, United States
Washington Cancer Institute
Washington D.C., District of Columbia, 20010, United States
Florida Cancer Specialists-Broadway
Fort Myers, Florida, 33916, United States
Florida Cancer Specialists NORTH
St. Petersburg, Florida, 33705, United States
Piedmont Cancer Institute, PC
Atlanta, Georgia, 30318, United States
Loyola University Health System
Maywood, Illinois, 60153, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
North Shore Hematology Oncology Associates, PC
East Setauket, New York, 11733, United States
University of Rochester
Rochester, New York, 14642, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Seidman Cancer Center
Cleveland, Ohio, 44106, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Dayton Physicians, LLC
Kettering, Ohio, 45409, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
Tennessee Oncology- St Thomas Location
Nashville, Tennessee, 37205, United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, 37232, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Houston Methodist Hospital / Houston Methodist Cancer Center
Houston, Texas, 77030, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Millennium Oncology
Houston, Texas, 77090, United States
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708, United States
MultiCare Health System Institute for Research and Innovation
Auburn, Washington, 98001, United States
The Tweed Hospital
Tweed Heads, New South Wales, 2485, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Peninsula and South Eastern Haematology & Oncology Group
Frankston, Victoria, 3199, Australia
Peter MacCallum Cancer
Melbourne, Victoria, 3000, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, 6008, Australia
Institut Jules-Bordet
Brussels, 1000, Belgium
Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
AZ Sint-Lucas - Campus Sint-Lucas
Ghent, 9000, Belgium
Universitaire Ziekenhuizen Leuven
Leuven, 3000, Belgium
CHU UCL Namur site de Sainte Elisabeth
Namur, 5000, Belgium
NOB - Nucleo de Oncologia da Bahia
Salvador, Estado de Bahia, 40170-110, Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Catarina Pesquisa Clinica
ItajaÃ, Santa Catarina, 88301-220, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, São Paulo, 09060-650, Brazil
ICESP - Instituto do Cancer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo, São Paulo, 01246-000, Brazil
ClÃnica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda.
São Paulo, São Paulo, 01317-001, Brazil
Instituto Americas
Rio de Janeiro, 22793-080, Brazil
A. C. Camargo Cancer Center
São Paulo, 01509-900, Brazil
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Toronto Sunnybrook Hospital
Toronto, Ontario, M4N 3M5, Canada
St. Mary's Hospital
Montreal, Quebec, H3T 1M5, Canada
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, 510060, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
Sir Run Run Shaw Hospital Xiasha Branch, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310000, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Centre Paul Strauss
Strasbourg, Bas Rhin, 67000, France
Hôpital Nord - CHU Marseille
Marseille, Bouches-du-Rhone, 13915, France
Centre François Baclesse
Caen, Calvados, 14076, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, Cedex 02, Sarthe, 72015, France
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
Plérin, Cotes d'Armor, 22190, France
Centre Georges François Leclerc
Dijon, Côte-d'Or, 21079, France
CHRU Jean Minjoz
Besançon, Doubs, 25030, France
Institut Bergonié
Bordeaux, Gironde, 33076, France
Centre René Huguenin
Saint-Cloud, Hauts De Seine, 92110, France
ICM Val d'Aurelle
Montpellier, Herault, 34298, France
CRLCC Eugene Marquis
Rennes, Ille Et Vilaine, 35042, France
ICO - Site René Gauducheau
Saint-Herblain, Loire Atlantique, 44805, France
ICO - Site Paul Papin
Angers, Maine Et Loire, 49055, France
Centre de cancerologie les Dentellieres
Valenciennes, Nord, 59300, France
Centre Leon Berard
Lyon, Rhone, 69373, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhone, 69495, France
Institut Sainte Catherine
Avignon, Vaculuse, 84918, France
Hôpital d'Instruction des Armees Begin
Saint-Mandé, Val De Marne, 94160, France
Institut Gustave Roussy
Villejuif, Val De Marne, 94805, France
Institut Curie - site de Paris
Paris, 75005, France
Hôpital Saint-Louis
Paris, 75010, France
Hopital Tenon
Paris, 75020, France
Universitaetsklinikum Erlangen
Erlangen, Bavaria, 91-54, Germany
Rotkreuzklinikum Muenchen gGmbH
Munich, Bavaria, 80637, Germany
Klinikum rechts der Isar der TU Muenchen
Munich, Bavaria, 81675, Germany
Universitaetsklinikum Duesseldorf AoeR
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Haematologisch-Onkologische Schwerpunktpraxis
Troisdorf, North Rhine-Westphalia, 53840, Germany
Marienhospital Bottrop gGmbH
Bottrop, Rhineland-Palatinate, 46236, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lübeck, Schleswig-Holstein, 23538, Germany
The Chinese
Hong Kong, 00000, Hong Kong
The University of Hong Kong
Shatin, 00000, Hong Kong
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
Cona, Ferrara, 44124, Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), U.O Oncologia Medica
Monza, Milano, 20900, Italy
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
IRCCS Centro di Riferimento Oncologico
Aviano, Pordenone, 33081, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, 24127, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, 40138, Italy
Istituto Nazionale per la Ricerca sul Cancro di Genova
Genova, 16132, Italy
Azienda Ospealiera della Provincia di Lecco
Lecco, 23900, Italy
Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
Messina, 98158, Italy
Ospedale San Raffaele
Milan, 20132, Italy
IEO Istituto Europeo di Oncologia
Milan, 20141, Italy
A.O.U. Policlinico di Modena
Modena, 41124, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, 80131, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, 43100, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, 10126, Italy
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku, Tokyo-To, 162-8655, Japan
Aichi Cancer Center Hospital
Aichi, 464-8681, Japan
NHO Shikoku Cancer Center
Ehime, 791-0280, Japan
NHO Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518, Japan
NHO Hokkaido Cancer Center
Hokkaido, 003-0804, Japan
Kanagawa Cancer Center
Kanagawa, 241-8515, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Niigata Cancer Center
Niigata, 951-8566, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
NHO Osaka National Hospital
Osaka, 540-0006, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Saitama Cancer Center
Saitama, 362-0806, Japan
Shizuoka Cancer Center
Shizuoka, 411-8777, Japan
National Cancer Center Hospital
Tokyo, 104-0045, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550, Japan
Showa University Hospital
Tokyo, 142-8666, Japan
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, 15006, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, 15706, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Universitario Virgen Macarena
Seville, Sevill, 41009, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Hospital Infanta Cristina
Badajoz, 6007, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
IOB-Institute of Oncology
Barcelona, 8023, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
MD Anderson Cancer Centre
Madrid, 28033, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Koo Foundation, Sun Yat-Sen Cancer Center
Taipei, 112, Taiwan
Royal Devon and Exeter Hospital (Wonford)
Exeter, Devon, EX2 5DW, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Grampian Region, AB25 2ZB, United Kingdom
Queen Mary University of London
London, Greater London, EC1M 6BQ, United Kingdom
University College London Hospitals
London, Greater London, NW1 2PG, United Kingdom
Guy's Hospital
London, Greater London, SE1 9RY, United Kingdom
Sarah Cannon Research Institute UK
London, Greater London, W1G 6AD, United Kingdom
The Christie Hospital
Manchester, Greater Manchester, M20 4BX, United Kingdom
Western General Hospital
Edinburgh, Lothian Region, EH4 2XU, United Kingdom
Nottingham University Hospitals City Campus
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX, United Kingdom
Related Publications (9)
Iwata H, Xu B, Kim SB, Chung WP, Park YH, Kim MH, Tseng LM, Chung CF, Huang CS, Kim JH, Chiu JWY, Yamashita T, Li W, Egorov A, Nishijima S, Nakatani S, Nishiyama Y, Sugihara M, Cortes J, Im SA. Trastuzumab deruxtecan versus trastuzumab emtansine in Asian patients with HER2-positive metastatic breast cancer. Cancer Sci. 2024 Sep;115(9):3079-3088. doi: 10.1111/cas.16234. Epub 2024 Jul 9.
PMID: 38979893DERIVEDCortes J, Hurvitz SA, Im SA, Iwata H, Curigliano G, Kim SB, Chiu JWY, Pedrini JL, Li W, Yonemori K, Bianchini G, Loi S, Borges GS, Wang X, Bachelot T, Nakatani S, Ashfaque S, Liang Z, Egorov A, Hamilton E. Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer: long-term survival analysis of the DESTINY-Breast03 trial. Nat Med. 2024 Aug;30(8):2208-2215. doi: 10.1038/s41591-024-03021-7. Epub 2024 Jun 2.
PMID: 38825627DERIVEDMa R, Shi Y, Yan R, Yin S, Bu H, Huang J. Efficacy and safety of trastuzumab deruxtecan in treating human epidermal growth factor receptor 2-low/positive advanced breast cancer:A meta-analysis of randomized controlled trials. Crit Rev Oncol Hematol. 2024 Apr;196:104305. doi: 10.1016/j.critrevonc.2024.104305. Epub 2024 Mar 3.
PMID: 38442809DERIVEDCortes J. Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer: a plain language summary of the DESTINY-Breast03 study. Future Oncol. 2024 Feb;20(4):167-178. doi: 10.2217/fon-2023-0422. Epub 2023 Dec 7.
PMID: 38059424DERIVEDRugo HS, Crossno CL, Gesthalter YB, Kelley K, Moore HB, Rimawi MF, Westbrook KE, Buys SS. Real-World Perspectives and Practices for Pneumonitis/Interstitial Lung Disease Associated With Trastuzumab Deruxtecan Use in Human Epidermal Growth Factor Receptor 2-Expressing Metastatic Breast Cancer. JCO Oncol Pract. 2023 Aug;19(8):539-546. doi: 10.1200/OP.22.00480. Epub 2023 May 19.
PMID: 37207306DERIVEDCurigliano G, Dunton K, Rosenlund M, Janek M, Cathcart J, Liu Y, Fasching PA, Iwata H. Patient-reported outcomes and hospitalization data in patients with HER2-positive metastatic breast cancer receiving trastuzumab deruxtecan or trastuzumab emtansine in the phase III DESTINY-Breast03 study. Ann Oncol. 2023 Jul;34(7):569-577. doi: 10.1016/j.annonc.2023.04.516. Epub 2023 May 12.
PMID: 37179020DERIVEDHurvitz SA, Hegg R, Chung WP, Im SA, Jacot W, Ganju V, Chiu JWY, Xu B, Hamilton E, Madhusudan S, Iwata H, Altintas S, Henning JW, Curigliano G, Perez-Garcia JM, Kim SB, Petry V, Huang CS, Li W, Frenel JS, Antolin S, Yeo W, Bianchini G, Loi S, Tsurutani J, Egorov A, Liu Y, Cathcart J, Ashfaque S, Cortes J. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: updated results from DESTINY-Breast03, a randomised, open-label, phase 3 trial. Lancet. 2023 Jan 14;401(10371):105-117. doi: 10.1016/S0140-6736(22)02420-5. Epub 2022 Dec 7.
PMID: 36495879DERIVEDRugo HS, Bianchini G, Cortes J, Henning JW, Untch M. Optimizing treatment management of trastuzumab deruxtecan in clinical practice of breast cancer. ESMO Open. 2022 Aug;7(4):100553. doi: 10.1016/j.esmoop.2022.100553. Epub 2022 Aug 11.
PMID: 35964548DERIVEDCortes J, Kim SB, Chung WP, Im SA, Park YH, Hegg R, Kim MH, Tseng LM, Petry V, Chung CF, Iwata H, Hamilton E, Curigliano G, Xu B, Huang CS, Kim JH, Chiu JWY, Pedrini JL, Lee C, Liu Y, Cathcart J, Bako E, Verma S, Hurvitz SA; DESTINY-Breast03 Trial Investigators. Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer. N Engl J Med. 2022 Mar 24;386(12):1143-1154. doi: 10.1056/NEJMoa2115022.
PMID: 35320644DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Contact for Clinical Trial Information
- Organization
- Daiichi Sankyo
Study Officials
- STUDY DIRECTOR
Global Team Leader
Daiichi Sankyo
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2018
First Posted
May 18, 2018
Study Start
August 9, 2018
Primary Completion
May 21, 2021
Study Completion
July 30, 2026
Last Updated
October 21, 2025
Results First Posted
April 29, 2022
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
- Access Criteria
- Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/