AzTrials
AzTrials

Breast CancerPhase 3NCT03529110

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 study testing Trastuzumab deruxtecan (T-DXd) and Ado-trastuzumab emtansine (T-DM1) in people with Breast Cancer, run by Daiichi Sankyo at 164 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Trastuzumab deruxtecan (T-DXd) and Ado-trastuzumab emtansine (T-DM1)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
524 participants
Where
164 sitesin 15 countries
Study dates
9 Aug 2018to 31 Aug 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • 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;
Show all 13Show fewer
  • 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.

Trial locations and contacts

164 sites in 15 countries.

164 sites in 15 countries

United States28 sites

  • Piedmont Cancer Institute, PC

    Atlanta, Georgia, 30318

  • MultiCare Health System Institute for Research and Innovation

    Auburn, Washington, 98001

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • Seidman Cancer Center

    Cleveland, Ohio, 44106

  • The Ohio State University

    Columbus, Ohio, 43210

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • North Shore Hematology Oncology Associates, PC

    East Setauket, New York, 11733

  • Florida Cancer Specialists-Broadway

    Fort Myers, Florida, 33916

  • Houston Methodist Hospital / Houston Methodist Cancer Center

    Houston, Texas, 77030

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Millennium Oncology

    Houston, Texas, 77090

  • Dayton Physicians, LLC

    Kettering, Ohio, 45409

  • UCLA Hematology Oncology

    Los Angeles, California, 90095

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • Loyola University Health System

    Maywood, Illinois, 60153

  • Tennessee Oncology- St Thomas Location

    Nashville, Tennessee, 37205

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37232

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • University of Rochester

    Rochester, New York, 14642

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • University of California San Francisco

    San Francisco, California, 94115

  • Florida Cancer Specialists NORTH

    St. Petersburg, Florida, 33705

  • The University of Texas Health Science Center at Tyler

    Tyler, Texas, 75708

  • Washington Cancer Institute

    Washington D.C., District of Columbia, 20010

  • Innovative Clinical Research Institute

    Whittier, California, 90603

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

France22 sites

  • ICO - Site Paul Papin

    Angers, Maine Et Loire, 49055

  • Institut Sainte Catherine

    Avignon, Vaculuse, 84918

  • CHRU Jean Minjoz

    Besançon, Doubs, 25030

  • Institut Bergonié

    Bordeaux, Gironde, 33076

  • Centre François Baclesse

    Caen, Calvados, 14076

  • Centre Georges François Leclerc

    Dijon, Côte-d'Or, 21079

  • Clinique Victor Hugo - Centre Jean Bernard

    Le Mans, Cedex 02, Sarthe, 72015

  • Centre Leon Berard

    Lyon, Rhone, 69373

  • Hôpital Nord - CHU Marseille

    Marseille, Bouches-du-Rhone, 13915

  • ICM Val d'Aurelle

    Montpellier, Herault, 34298

  • Institut Curie - site de Paris

    Paris, 75005

  • Hôpital Saint-Louis

    Paris, 75010

  • Hopital Tenon

    Paris, 75020

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Rhone, 69495

  • CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

    Plérin, Cotes d'Armor, 22190

  • CRLCC Eugene Marquis

    Rennes, Ille Et Vilaine, 35042

  • Centre René Huguenin

    Saint-Cloud, Hauts De Seine, 92110

  • ICO - Site René Gauducheau

    Saint-Herblain, Loire Atlantique, 44805

  • Hôpital d'Instruction des Armees Begin

    Saint-Mandé, Val De Marne, 94160

  • Centre Paul Strauss

    Strasbourg, Bas Rhin, 67000

  • Centre de cancerologie les Dentellieres

    Valenciennes, Nord, 59300

  • Institut Gustave Roussy

    Villejuif, Val De Marne, 94805

Other trials in France

Japan17 sites

  • Aichi Cancer Center Hospital

    Aichi, 464-8681

  • NHO Shikoku Cancer Center

    Ehime, 791-0280

  • NHO Kyushu Cancer Center

    Fukuoka, 811-1395

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518

  • NHO Hokkaido Cancer Center

    Hokkaido, 003-0804

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Niigata Cancer Center

    Niigata, 951-8566

  • Okayama University Hospital

    Okayama, 700-8558

  • NHO Osaka National Hospital

    Osaka, 540-0006

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Saitama Cancer Center

    Saitama, 362-0806

  • Center Hospital of the National Center for Global Health and Medicine

    Shinjuku-Ku, Tokyo-To, 162-8655

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

  • Showa University Hospital

    Tokyo, 142-8666

Other trials in Japan

Spain17 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, La Coruña, 15006

  • Hospital Infanta Cristina

    Badajoz, 6007

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • IOB-Institute of Oncology

    Barcelona, 8023

  • ICO l'Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • MD Anderson Cancer Centre

    Madrid, 28033

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, La Coruña, 15706

  • Hospital Universitario Virgen Macarena

    Seville, Sevill, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

Italy16 sites

  • IRCCS Centro di Riferimento Oncologico

    Aviano, Pordenone, 33081

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

    Bergamo, 24127

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

    Cona, Ferrara, 44124

  • Istituto Nazionale per la Ricerca sul Cancro di Genova

    Genova, 16132

  • Azienda Ospealiera della Provincia di Lecco

    Lecco, 23900

  • Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

    Messina, 98158

  • Ospedale San Raffaele

    Milan, 20132

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

  • A.O.U. Policlinico di Modena

    Modena, 41124

  • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), U.O Oncologia Medica

    Monza, Milano, 20900

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43100

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

China12 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Sun Yat-sen University, Cancer Center

    Guangzhou, Guangdong, 510060

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

  • Sir Run Run Shaw Hospital Xiasha Branch, Zhejiang University, School of Medicine

    Hangzhou, Zhejiang, 310000

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110042

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

Other trials in China

United Kingdom10 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Grampian Region, AB25 2ZB

  • Western General Hospital

    Edinburgh, Lothian Region, EH4 2XU

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, Devon, EX2 5DW

  • Royal Surrey County Hospital

    Guildford, Surrey, GU2 7XX

  • Queen Mary University of London

    London, Greater London, EC1M 6BQ

  • University College London Hospitals

    London, Greater London, NW1 2PG

  • Guy's Hospital

    London, Greater London, SE1 9RY

  • Sarah Cannon Research Institute UK

    London, Greater London, W1G 6AD

  • The Christie Hospital

    Manchester, Greater Manchester, M20 4BX

  • Nottingham University Hospitals City Campus

    Nottingham, Nottinghamshire, NG5 1PB

Other trials in United Kingdom

Brazil8 sites

  • Catarina Pesquisa Clinica

    Itajaí, Santa Catarina, 88301-220

  • Hospital Nossa Senhora da Conceição

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Instituto Americas

    Rio de Janeiro, 22793-080

  • NOB - Nucleo de Oncologia da Bahia

    Salvador, Estado de Bahia, 40170-110

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    Santo André, São Paulo, 09060-650

  • ICESP - Instituto do Cancer do Estado de São Paulo Octavio Frias de Oliveira

    São Paulo, São Paulo, 01246-000

  • Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda.

    São Paulo, São Paulo, 01317-001

  • A. C. Camargo Cancer Center

    São Paulo, 01509-900

Other trials in Brazil

Germany7 sites

  • Marienhospital Bottrop gGmbH

    Bottrop, Rhineland-Palatinate, 46236

  • Universitaetsklinikum Duesseldorf AoeR

    Düsseldorf, North Rhine-Westphalia, 40225

  • Universitaetsklinikum Erlangen

    Erlangen, Bavaria, 91-54

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, Schleswig-Holstein, 23538

  • Rotkreuzklinikum Muenchen gGmbH

    Munich, Bavaria, 80637

  • Klinikum rechts der Isar der TU Muenchen

    Munich, Bavaria, 81675

  • Haematologisch-Onkologische Schwerpunktpraxis

    Troisdorf, North Rhine-Westphalia, 53840

Other trials in Germany

Australia6 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Peninsula and South Eastern Haematology & Oncology Group

    Frankston, Victoria, 3199

  • Peter MacCallum Cancer

    Melbourne, Victoria, 3000

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, 6008

  • The Tweed Hospital

    Tweed Heads, New South Wales, 2485

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Belgium6 sites

  • Institut Jules-Bordet

    Brussels, 1000

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • AZ Sint-Lucas - Campus Sint-Lucas

    Ghent, 9000

  • Universitaire Ziekenhuizen Leuven

    Leuven, 3000

  • CHU UCL Namur site de Sainte Elisabeth

    Namur, 5000

Other trials in Belgium

South Korea5 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Taiwan5 sites

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Koo Foundation, Sun Yat-Sen Cancer Center

    Taipei, 112

Other trials in Taiwan

Canada3 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • St. Mary's Hospital

    Montreal, Quebec, H3T 1M5

  • Toronto Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Hong Kong2 sites

  • The Chinese

    Hong Kong, 00000

  • The University of Hong Kong

    Shatin, 00000

Other trials in Hong Kong

About this study

Official title: 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

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.

Conditions
Breast Cancer
Being tested
Trastuzumab deruxtecan (T-DXd), Ado-trastuzumab emtansine (T-DM1)
Keywords
Breast Cancer, Metastatic breast cancer, DS-8201a, DESTINY - Breast 03
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab deruxtecan (T-DXd)Drug

    Also called DS-8201a

    T-DXd is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously.

  • Ado-trastuzumab emtansine (T-DM1)Drug

    Also called T-DM1

    The treatment will be in accordance with the approved label.

Study groups in NCT03529110
Study groupRoleWhat they receive
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).
Receives: Drug: Trastuzumab deruxtecan (T-DXd)
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.
Receives: Drug: Ado-trastuzumab emtansine (T-DM1)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 33 months (data cut-off)

Secondary outcomes (4)

  1. Overall Survival (OS) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane

    Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.

    Measured: Up to 33 months (data cut-off)

  2. 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

    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 is reported.

    Measured: Up to 33 months (data cut-off)

  3. 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

    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.

    Measured: Up to 33 months (data cut-off)

  4. 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

    Progression-free survival (PFS) by investigator assessment 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.

    Measured: Up to 33 months (data cut-off)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2018
  2. Study start9 Aug 2018
  3. Primary completion21 May 2021
  4. Study completion31 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
524 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03529110
Sponsor's protocol ID
DS8201-A-U302
Other IDs
2018-000222-61, jRCT2080223919, DESTINY-B03, CTR20190378, 2024-511204-16-00, 2018
Status last verified
Sep 2026
First submitted
13 Apr 2018
Last updated
7 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Publications

  • 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.

    PubMed 38979893

  • Cortes 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.

    PubMed 38825627

  • Ma 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.

    PubMed 38442809

  • Cortes 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.

    PubMed 38059424

  • Rugo 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.

    PubMed 37207306

  • Curigliano 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.

    PubMed 37179020

  • Hurvitz 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.

    PubMed 36495879

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab deruxtecan (T-DXd) and Ado-trastuzumab emtansine (T-DM1) in people with Breast Cancer, run by Daiichi Sankyo at 164 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 164 sites in United States, France, Japan, Spain, Italy and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Up to 33 months (data cut-off)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03529110, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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