AzTrials
AzTrials

Breast CancerPhase 3NCT03523585

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

A Phase 3 study testing Trastuzumab deruxtecan, Capecitabine and Lapatinib in people with Breast Cancer, run by Daiichi Sankyo at 227 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 will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: cannot be removed by an operation has spread to other parts of the body 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, Capecitabine and Lapatinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
608 participants
Where
227 sitesin 15 countries
Study dates
1 Aug 2018to 23 Dec 2025
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

  • Is the age of majority in their country
  • Has pathologically documented breast cancer that:
  • is unresectable or metastatic
  • has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
  • was previously treated with ado-trastuzumab emtansine (T-DM1)
  • Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy)
Show all 12Show fewer
  • Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.
  • Male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least:
  • 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males)
  • 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)
  • 7 months after the last dose of trastuzumab/capecitabine
  • Has adequate hematopoietic, renal and hepatic functions

Who cannot join

  • Has previously participated in an antibody drug conjugate study sponsored by Daiichi Sankyo. Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy
  • Has had prior treatment with capecitabine
  • Has uncontrolled or significant cardiovascular disease
  • Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
  • Has active central nervous system (CNS) metastases

Trial locations and contacts

227 sites in 15 countries.

227 sites in 15 countries

United States41 sites

  • Piedmont Cancer Institute, PC

    Atlanta, Georgia, 30318

  • University of Maryland

    Baltimore, Maryland, 21201

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Ironwood Cancer Research Centers

    Chandler, Arizona, 85224

  • Tennessee Oncology, PLLC Chattanooga

    Chattanooga, Tennessee, 37404

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43235

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • North Shore Hematology Oncology Associates, PC

    East Setauket, New York, 11733

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Florida Cancer Specialists-Broadway

    Fort Myers, Florida, 33901

  • The West Clinic

    Germantown, Tennessee, 38138

  • Kapiolani Medical Center for Women and Children/Univ of HI

    Honolulu, Hawaii, 96826

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

  • Cornell-Beshore Cancer Institute

    Joplin, Missouri, 64804

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111

  • Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC

    Kansas City, Missouri, 64132

  • Dayton Physicians, LLC

    Kettering, Ohio, 45409

  • UCLA Hematology Oncology - Main Site

    Los Angeles, California, 90095

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • Loyola University Health System

    Maywood, Illinois, 60153

  • Pacific Cancer Care

    Monterey, California, 93940

  • Community Hospital

    Munster, Indiana, 46321

  • SCRI - Tennessee Oncology

    Nashville, Tennessee, 37203

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut, 06510

  • Memorial Sloan-Kettering Cancer Center (MSKCC) - New York

    New York, New York, 10065

  • Community Cancer Trials of Utah

    Ogden, Utah, 84405

  • Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • UPMC Cancer Center

    Pittsburgh, Pennsylvania, 15213

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Maine Center for Cancer Medicine

    Scarborough, Maine, 04074

  • Washington University

    St Louis, Missouri, 63110

  • MultiCare Health System Institute for Research and Innovation

    Tacoma, Washington, 98405

  • 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

Other trials in United States

France23 sites

  • Hôpital Privé d'Antony

    Antony, Hauts De Seine, 92160

  • Institut Sainte Catherine

    Avignon, Vaculuse, 84918

  • Centre Hospitalier de la côte Basque

    Bayonne, Pyrenees Atlantiques, 64109

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, Doubs, 25030

  • CHU Brest - Hôpital Morvan

    Brest, Finistere, 29609

  • Centre François Baclesse

    Caen, Calvados, 14076

  • Centre Georges François Leclerc

    Dijon, Côte-d'Or, 21079

  • Clinique Victor Hugo - Centre Jean Bernard

    Le Mans, Sarthe, 72015

  • Centre Oscar Lambret

    Lille, Nord, 59020

  • Hôpital Nord - CHU Marseille

    Marseille, Bouches-du-Rhône, 13915

  • Clinique Clementville

    Montpellier, Herault, 34070

  • Institut Régional du Cancer de Montpellier

    Montpellier, Herault, 34298

  • Institut Régional du Cancer de Montpellier

    Montpellier, 34298

  • Institut Curie - site de Paris

    Paris, Paris, 75005

  • Institut Curie - site de Paris

    Paris, 75005

  • 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 Henri Becquerel

    Rouen, Seine Maritime, 76038

  • Centre René Huguenin

    Saint-Cloud, Hauts De Seine, 92110

  • Centre de cancerologie les Dentellieres

    Valenciennes, Nord, 59300

  • Institut Gustave Roussy

    Villejuif, Val De Marne, 94805

Other trials in France

Japan23 sites

  • National Cancer Center Hospital

    Chūōku, Tokyo-To, 104-0045

  • NHO Shikoku Cancer Center

    Ehime, 791-0280

  • NHO Kyushu Cancer Center

    Fukuoka, 811-1395

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518

  • NHO Hokkaido Cancer Center

    Hokkaido, 003-0804

  • Hyōgo College of Medicine Hospital

    Hyōgo, 663-8501

  • St. Marianna University School of Medicine Hospital

    Kanagawa, 216-8511

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Tohoku University Hospital

    Miyagi, 980-8574

  • Aichi Cancer Center Hospital

    Nagoya, 464-8681

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Okayama University Hospital

    Okayama, 700-8558

  • NHO Osaka National Hospital

    Osaka, 540-0006

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511

  • Kindai University Hospital

    Ōsakasayama-shi, Osaka, 589-8511

  • Saitama Cancer Center

    Saitama, 362-0806

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • Toranomon Hospital

    Tokyo, 105-8470

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

  • Tokyo Medical University Hospital

    Tokyo, 160-0023

Other trials in Japan

Spain20 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, La Coruña, 15006

  • Hospital Infanta Cristina

    Badajoz, 06007

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Quironsalud Barcelona

    Barcelona, 08023

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital del Mar

    Barcelona, 8003

  • Hospital de Especialidades de Jerez de la Frontera

    Jerez de la Frontera, Cádiz, 11407

  • ICO l'Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • MD Anderson Cancer Centre

    Madrid, 28033

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario de Salamanca

    Salamanca, 37370

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Instituto Valenciano de Oncologia IVO

    Valencia, 46009

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Italy19 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, 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

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

  • A.O.U. Policlinico di Modena

    Modena, 41124

  • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

    Monza, Milano, 20900

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131

  • Ospedale Sacro Cuore Don Calabria

    Negrar, Verona, 37024

  • IOV - Istituto Oncologico Veneto IRCCS

    Padova, 35128

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43100

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Australia16 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Calvary North Adelaide Hospital

    Bruce, 2614

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Peninsula and South Eastern Haematology & Oncology Group

    Frankston, Victoria, 3199

  • Austin Health

    Heidelberg, Victoria, 3084

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Sunshine Hospital

    Saint Albans, Victoria, 3021

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, 6008

  • Macquarie University Hospital

    Sydney, New South Wales, 2109

  • The Tweed Hospital

    Tweed Heads, New South Wales, 2485

  • South West Oncology

    Warrnambool, Victoria, 3280

  • Ballarat Oncology & Haematology Service

    Wendouree, Victoria, 3355

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Turkey (Türkiye)16 sites

  • Acibadem Adana Hospital

    Adana, 01130

  • Adana Numune Training and Research Hospital

    Adana, 01370

  • Ankara Yildirim Beyazit Uni. Med. Fac.Ankara City Hospital

    Ankara, 6800

  • Akdeniz University Medical Faculty

    Antalya, 07058

  • Uludag University Medical Faculty

    Bursa, 16059

  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital

    Istanbul, 34147

  • Medipol University Medical Faculty

    Istanbul, 34214

  • Medical Park Goztepe Hospital

    Istanbul, 34732

  • Istanbul Medeniyet Uni Goztepe Training & Research Hospital

    Istanbul, 34854

  • Kartal Lutfi Kirdar Research and Training Hospital

    Istanbul, 34890

  • Izmir Medicalpark Hospital

    Izmir, 35530

  • Konya Necmettin Erbakan University Meram Faculty of Medicine

    Konya, 42080

  • Sakarya Traning and Research Hospital

    Sakarya, 54187

  • Medical Park Samsun Hastanesi

    Samsun, 55200

  • Namik Kemal University

    Tekirdağ, 59100

Other trials in Turkey (Türkiye)

Brazil14 sites

  • Pronutrir

    Fortaleza, Ceará, 60810-180

  • Clínica de Neoplasias Litoral Ltda.

    Itajaí, Santa Catarina, 88301-220

  • Oncobio Servicos de Saude

    Nova Lima, Minas Gerais, 34000

  • HGB - Hospital Giovanni Battista - Mãe de Deus Center

    Porto Alegre, Rio Grande do Sul, 90110-270

  • CliniOnco - Tratamento Integrado do Câncer

    Porto Alegre, Rio Grande do Sul, 90430-090

  • Escosteguy Barrios, Carlos Henrique

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Nossa Senhora da Conceição

    Porto Alegre, Rio Grande do Sul, 91350-200

  • COI - Clínicas Oncológicas Integradas

    Rio de Janeiro, 22793-080

  • NOB - Núcleo de Oncologia da Bahia

    Salvador, Estado de Bahia, 40170-110

  • AMO - Assistência Multidisciplinar em Oncologia

    Salvador, Estado de Bahia, 41950-640

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

    Santo André, São Paulo, 09060-650

  • IBCC - Instituto Brasileiro de Controle do Câncer

    São Paulo, São Paulo, 03102-002

  • Sociedade Beneficiente de Senhoras Hospital Sírio Libanês

    São Paulo, 01308

  • A. C. Camargo Cancer Center

    São Paulo, 01509-900

Other trials in Brazil

South Korea13 sites

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • National Cancer Center

    Goyang-si, 10408

  • Inha University Hospital

    Incheon, Gyeonggi-do, 22332

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University

    Seoul, 03772

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Gyeonggi-do, 16247

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

Germany11 sites

  • Helios-Kliniken Berlin-Buch

    Berlin, 13125

  • Marienhospital Bottrop gGmbH

    Bottrop, Rhineland-Palatinate, 46236

  • Kliniken Koeln

    Cologne, 51067

  • Universitaetsklinikum Duesseldorf AoeR

    Düsseldorf, 40225

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

  • Universitaetsklinikum Leipzig AoeR

    Leipzig, 04103

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, Schleswig-Holstein, 23538

  • Universitaetsklinikum Muenster

    Müenster, 48149

  • Klinikum rechts der Isar der TU Muenchen

    Munich, Bavaria, 81675

  • Klinikum der Universitaet Muenchen - Campus Grosshardern

    Munich, 81377

  • Haematologisch-Onkologische Schwerpunktpraxis

    Troisdorf, 53840

Other trials in Germany

United Kingdom9 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

  • Queen Mary University of London

    London, Greater London, EC1M 6BQ

  • University College London Hospitals

    London, Greater London, NW1 2PG

  • Sarah Cannon Research Institute UK

    London, Greater London, W1G 6AD

  • Nottingham University Hospitals City Campus

    Nottingham, Nottinghamshire, NG5 1PB

  • Derriford Hospital

    Plymouth, Devon, PL6 8BQ

  • Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Israel7 sites

  • Rambam Health Care Center

    Haifa, 3109601

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001

  • Sapir Medical Center, Meir Hospital

    Kfar Saba, 4428164

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva, 49100

  • Chaim Sheba Medical Center

    Ramat Gan, 52363

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Belgium6 sites

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • AZ Maria Middelares

    Ghent, 9000

  • Az Groeninge

    Kortrijk, 8500

  • UZ Leuven

    Leuven, 3000

  • CHU UCL Namur site de Sainte Elisabeth

    Namur, 5000

Other trials in Belgium

Greece5 sites

  • 251 General Air Force Hospital

    Athens, 11525

  • General Hospital of Athens "Alexandra"

    Athens, 11528

  • General Oncology Hospital of Kifissia " Agioi Anargyroi"

    Athens, 14564

  • University General Hospital of Heraklion

    Heraklion, 71110

  • Euromedica General Clinic Thessaloniki

    Thessaloniki, 54645

Other trials in Greece

Czechia4 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20

  • Fakultni nemocnice v Motole

    Prague, 150 06

  • Nemocnice Na Bulovce

    Prague, 180 81

Other trials in Czechia

About this study

Official title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1

This study will compare DS 8201a to standard treatment.

Participants must have HER2 breast cancer that has been treated before.

Their cancer:

  • cannot be removed by an operation
  • has spread to other parts of the body
Read the detailed description

The study is designed to compare DS 8201a versus standard of care (investigator's choice) in subjects with unresectable and/or metastatic breast cancer previously treated with T-DM1.

Conditions
Breast Cancer
Being tested
Trastuzumab deruxtecan, Capecitabine, Lapatinib, Trastuzumab
Keywords
Breast Cancer, Metastatic breast cancer, DS 8201a, DESTINY - Breast 02
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 deruxtecanDrug

    Also called DS-8201a, T-DXd

    DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as intravenous (IV) dose

  • CapecitabineDrug

    Also called Investigator's Choice Comparative Therapy

    Investigator's choice Standard of Care when combined with trastuzumab or lapatinib

  • LapatinibDrug

    Also called Investigator's Choice Comparative Therapy

    Investigator's choice Standard of Care when combined with capecitabine

  • TrastuzumabDrug

    Also called Investigator's Choice Comparative Therapy

    Investigator's choice Standard of Care when combined with capecitabine

Study groups in NCT03523585
Study groupRoleWhat they receive
Trastuzumab deruxtecan (DS-8201a)ExperimentalHER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to treatment with DS-8201a
Receives: Drug: Trastuzumab deruxtecan
Trastuzumab+capecitabineActive comparatorHER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Trastuzumab/capecitabine
Receives: Drug: Capecitabine; Drug: Trastuzumab
Lapatinib+capecitabineActive comparatorHER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Lapatinib/capecitabine
Receives: Drug: Capecitabine; Drug: Lapatinib

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 Participants Previously Treated With Trastuzumab Emtansine

    Progression-free survival (PFS) by BICR was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause.

    Measured: Baseline up to 46 months postdose

Secondary outcomes (4)

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

    Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there is no death reported for a subject before the data cutoff for OS analysis, OS will be censored at the last contact date at which the subject is known to be alive.

    Measured: Baseline up to 46 months postdose

  2. Percentage of Participants With Objective Response Rate (ORR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine

    The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by BICR and investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on BICR and Investigator Assessment is reported.

    Measured: Baseline up to 46 months postdose

  3. Duration of Response (DoR) Based on BICR in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine

    Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR in participants with confirmed CR/PR based on BICR and investigator assessment is reported.

    Measured: Baseline up to 46 months postdose

  4. Progression-Free Survival (PFS) Based on Investigator Assessment in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine

    Progression-free survival (PFS) by investigator assessment was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause.

    Measured: Up to 46 months

Timeline

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

  1. First posted14 May 2018
  2. Study start1 Aug 2018
  3. Primary completion30 Jun 2022
  4. Study completion23 Dec 2025

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
608 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03523585
Sponsor's protocol ID
DS8201-A-U301
Other IDs
2018-000221-31, 184017, DESTINY-Breast02, 2018
Status last verified
Feb 2026
First submitted
13 Apr 2018
Last updated
27 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Publications

  • Andre F, Hee Park Y, Kim SB, Takano T, Im SA, Borges G, Lima JP, Aksoy S, Gavila Gregori J, De Laurentiis M, Bianchini G, Roylance R, Miyoshi Y, Armstrong A, Sinha R, Ruiz Borrego M, Lim E, Ettl J, Yerushalmi R, Zagouri F, Duhoux FP, Fehm T, Gambhire D, Cathcart J, Wu C, Chu C, Egorov A, Krop I. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 May 27;401(10390):1773-1785. doi: 10.1016/S0140-6736(23)00725-0. Epub 2023 Apr 20.

    PubMed 37086745

  • Fehm T, Cottone F, Dunton K, Andre F, Krop I, Park YH, De Laurentiis M, Miyoshi Y, Armstrong A, Borrego MR, Yerushalmi R, Duhoux FP, Takano T, Lu W, Egorov A, Kim SB. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): patient-reported outcomes from a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2024 May;25(5):614-625. doi: 10.1016/S1470-2045(24)00128-1.

    PubMed 38697155

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab deruxtecan, Capecitabine and Lapatinib in people with Breast Cancer, run by Daiichi Sankyo at 227 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 12 inclusion and 5 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 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 227 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 26 Jun 2023). 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 Participants Previously Treated With Trastuzumab Emtansine (time frame: Baseline up to 46 months postdose). 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 NCT03523585, which also lists 2 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 27 Feb 2026.

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