AzTrials
AzTrials

HER2-Positive Primary Breast CancerPhase 3NCT04622319

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)

A Phase 3 study testing DS-8201a and T-DM1 in people with HER2-Positive Primary Breast Cancer and Residual Invasive Breast Cancer, run by Daiichi Sankyo at 482 sites in 31 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DS-8201a and T-DM1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,600 participants
Where
482 sitesin 31 countries
Study dates
4 Dec 2020to 20 Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • 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:
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

482 sites in 31 countries.

482 sites in 31 countries

United States126 sites

  • SCRI FCS North- Altamonte

    Altamonte Springs, Florida, 32701

  • The Oncology Institute of Hope & Innovation

    Anaheim, California, 92801

  • Kaiser Permanente

    Anaheim, California, 92806

  • MultiCare Cancer Center Aurburn

    Auburn, Washington, 98002

  • Kaiser Permanente

    Baldwin Park, California, 91706

  • MedStar Franklin Square Medical Center-Harry and Jeanette Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • MedStar Franklin Square Cancer Center at Loch Raven Campus

    Baltimore, Maryland, 21239

  • LSU Health Baton Rouge North Clinic

    Baton Rouge, Louisiana, 70805

  • Our Lady of the Lake Physician Group-Medical Oncology

    Baton Rouge, Louisiana, 70808

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Houston Methodist Baytown

    Baytown, Texas, 77521

  • Kaiser Permanente

    Bellflower, California, 90706

  • UPMC Upper St. Clair

    Bethel Park, Pennsylvania, 15102

  • SCRI FCS South- Bonita

    Bonita Springs, Florida, 34135

  • SCRI FCS North- Brandon Cancer Center

    Brandon, Florida, 33511

  • Wellmont Medical Associates Oncology & Hematology

    Bristol, Virginia, 24201

  • SCRI FCS South- North Fort Myers

    Cape Coral, Florida, 33909

  • Waverly Hematology Oncology

    Cary, North Carolina, 27518

  • University of Virginia

    Charlottesville, Virginia, 22908

  • SCRI FCS North- Mease/Clearwater

    Clearwater, Florida, 33761

  • Cleveland Clinic - Hillcrest

    Cleveland, Ohio, 44195

  • Cleveland Clinic-Fairview

    Cleveland, Ohio, 44195

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ochsner Hematology Oncology North Shore - Covington (West Region)

    Covington, Louisiana, 70433

  • UPMC Passavant Cranberry/North

    Cranberry Township, Pennsylvania, 16066

  • Elmhurst Memorial Hospital- Nancy W. Knowles Cancer Center

    Elmhurst, Illinois, 60126

  • UPMC Erie

    Erie, Pennsylvania, 16505

  • AHN Cancer Inst at St Vincent

    Erie, Pennsylvania, 16544

  • Kaiser Permanente

    Fontana, California, 92335

  • SCRI FCS South

    Fort Myers, Florida, 33901

  • SCRI FCS South- Colonial

    Fort Myers, Florida, 33905

  • SCRI FCS South- Gladiolus

    Fort Myers, Florida, 33908

  • Orange Coast Blood and Cancer Care

    Fountain Valley, California, 92708

  • SCRI TO Nashville- Franklin Tennessee Oncology, PLLC

    Franklin, Tennessee, 37067

  • Frederick Health-James M Stockman Cancer Center

    Frederick, Maryland, 21702

  • SCRI FCS North- Gainesville Cancer Center

    Gainesville, Florida, 32605

  • SCRI TO Nashville- Gallatin Tennessee Oncology, PLLC

    Gallatin, Tennessee, 37066

  • MultiCare Regional Cancer Center - Gig Harbor

    Gig Harbor, Washington, 98335

  • UPMC Arnold Palmer-Mt View

    Greensburg, Pennsylvania, 15601

  • Kaiser Permanente

    Harbor City, California, 90710

  • UPMC Pinnacle-Ortenzio Cancer Center

    Harrisburg, Pennsylvania, 17050

  • UMPC Pinnacle Pharmacy

    Harrisburg, Pennsylvania, 17109

  • SCRI TO Nashville- Hendersonville Tennessee Oncology, PLLC

    Hendersonville, Tennessee, 37075

  • SCRI TO Nashville- Summit Tennessee Oncology, PLLC

    Hermitage, Tennessee, 37076

  • Houston Methodist

    Houston, Texas, 77030

  • Houston Methodist Willowbrook

    Houston, Texas, 77070

  • Houston Methodist West

    Houston, Texas, 77094

  • Kaiser Permanente

    Irvine, California, 92618

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • AHN Cancer Insititute at Jefferson

    Jefferson Hills, Pennsylvania, 15025

  • Regional Cancer Center at Indian Path Community Hospital

    Kingsport, Tennessee, 37660

  • SCRI FCS North- Villages East

    Lady Lake, Florida, 32159

  • SCRI FCS South- Lakewood Ranch

    Lakewood Rch, Florida, 34211

  • SCRI FCS North- Largo/Highland

    Largo, Florida, 33770

  • SCRI TO Nashville- Lebanon Tennessee Oncology, PLLC

    Lebanon, Tennessee, 37090

  • SCRI FCS North- Lecanto

    Lecanto, Florida, 34461

  • University of Kentucky, Markey Cancer Center, Clinical Research Organization

    Lexington, Kentucky, 40536

  • Long Beach Memorial TCI

    Long Beach, California, 90806

  • Kaiser Permanente

    Los Angeles, California, 90027

  • Baptist Health Louisville

    Louisville, Kentucky, 40207

  • AHN Cancer Institute at Forbes

    Monroeville, Pennsylvania, 15146

  • UPMC Monroeville

    Monroeville, Pennsylvania, 15146

  • West Virginia University

    Morgantown, West Virginia, 26506

  • UPMC Arnold Palmer-Mt Pleasant

    Mount Pleasant, Pennsylvania, 15666

  • UPMC Arnold Palmer-Norwin

    N. Huntingdon, Pennsylvania, 15642

  • Edward Cancer Center

    Naperville, Illinois, 60540

  • SCRI FCS South- Naples West

    Naples, Florida, 34102

  • SCRI FCS South- Naples/Goodlette

    Naples, Florida, 34119

  • SCRI TO Nashville- St. Thomas Midtown Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Tennessee Oncology Nashville / Sarah Cannon

    Nashville, Tennessee, 37203

  • SCRI TO Nashville- St. Thomas West Tennessee Oncology, PLLC

    Nashville, Tennessee, 37205

  • SCRI TO Nashville- Skyline Tennessee Oncology, PLLC

    Nashville, Tennessee, 37207

  • SCRI TO Nashville- Southern Hills Tennessee Oncology, PLLC

    Nashville, Tennessee, 37211

  • Houston Methodist Clear Lake

    Nassau Bay, Texas, 77058

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • SCRI FCS North- New Port Richey

    New Port Richey, Florida, 34655

  • SCRI FCS North- Ocala

    Ocala, Florida, 34474

  • Orlando Health

    Ocoee, Florida, 34761

  • Kaiser Permanente

    Ontario, California, 90710

  • SCRI FCS North- Orange City

    Orange City, Florida, 32763

  • Orlando Health

    Orlando, Florida, 32806

  • SCRI FCS North- Orlando Downtown

    Orlando, Florida, 32806

  • Kaiser Permanente

    Panorama City, California, 91402

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Magee

    Pittsburgh, Pennsylvania, 15213

  • UPMC St. Margaret

    Pittsburgh, Pennsylvania, 15215

  • AHN Cancer Inst at West Penn

    Pittsburgh, Pennsylvania, 15224

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • UPMC Passavant HOA

    Pittsburgh, Pennsylvania, 15237

  • UPMC Passavant OHA

    Pittsburgh, Pennsylvania, 15237

  • Edward Cancer Center Plainfield

    Plainfield, Illinois, 60585

  • SCRI FCS South- Port Charlotte

    Port Charlotte, Florida, 33980

  • MultiCare Cancer Center Puyallup

    Puyallup, Washington, 98372

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298

  • Kaiser Permanente

    Riverside, California, 92505

  • UNC Cancer Care at Nash

    Rocky Mount, North Carolina, 27804

  • Kaiser Permanente

    San Diego, California, 92120

  • Kaiser Permanente

    San Marcos, California, 92078

  • SCRI FCS South- Sarasota-Cattleman

    Sarasota, Florida, 34232

  • SCRI FCS South-Sarasota-Downtown

    Sarasota, Florida, 34236

  • Maryland Oncology Hematology

    Silver Spring, Maryland, 20904

  • Holy Cross Hospital

    Silver Spring, Maryland, 20910

  • SCRI TO Nashville- Smyrna Tennessee Oncology, PLLC

    Smyrna, Tennessee, 37167

  • MultiCare Institute for Research & Innovation

    Spokane, Washington, 99204

  • MultiCare Institute for Research & Innovation

    Spokane, Washington, 99218

  • SCRI FCS North- Spring Hill

    Spring Hill, Florida, 34608

  • SCRI FCS North- St. Anthony's/St. Petersburg

    St. Petersburg, Florida, 33705

  • SCRI FCS North

    St. Petersburg, Florida, 33705

  • Houston Methodist Sugarland

    Sugar Land, Texas, 77479

  • MultiCare Cancer Center Tacoma

    Tacoma, Washington, 98405

  • SCRI FCS North- Tampa Cancer Center

    Tampa, Florida, 33607

  • SCRI FCS North- Tavares

    Tavares, Florida, 32778

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Houston Methodist Woodlands

    The Woodlands, Texas, 77385

  • UPMC Uniontown

    Uniontown, Pennsylvania, 15401

  • SCRI FCS South- Venice Healthpark

    Venice, Florida, 34292

  • Cleveland Clinic South Pointe

    Warrensville Heights, Ohio, 44195

  • UPMC Washington

    Washington, Pennsylvania, 15301

  • Kaiser Permanente

    West Los Angeles, California, 90034

  • Reading Hospital, McGlinn Cancer Institute

    West Reading, Pennsylvania, 19611

  • Cleveland Clinic-Weston

    Weston, Florida, 33326

  • AHN Cancer Institute at Wexford

    Wexford, Pennsylvania, 15090

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • SCRI FCS North- Winter Park

    Winter Park, Florida, 32792

  • Kaiser Permanente

    Woodland Hills, California, 91367

  • UPMC Pinnacle-Memorial Cancer Center

    York, Pennsylvania, 17408

Other trials in United States

Germany81 sites

  • Gemeinschaftspraxis Dres. Halder / Bangerter

    Augsburg, 86150

  • Cahrité Campus Mitte

    Berlin, 10117

  • Praxis Dr. med. J. Schilling

    Berlin, 10317

  • MediOnko-Institut GbR, Praxisklinik Krebsheilkunde

    Berlin, 10367

  • DRK Kliniken Berlin Köpenick

    Berlin, 12559

  • Helios Klinikum Berlin-Buch

    Berlin, 13125

  • Onkologische Schwerpunktpraxis

    Berlin, 13349

  • Onkologische Schwerpunktpraxis

    Bielefeld, 13349

  • Klinikverbund Südwest Kliniken Böblingen Frauenklinik Böblingen

    Böblingen, 71065

  • Studien GbR Braunschweig

    Braunschweig, 38108

  • Klinikum Bremen Mitte

    Bremen, 28205

  • Frauenklinik DIAKO Bremen

    Bremen, 28239

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

  • Unifrauenklinik Köln - Studienzentrum Gynäkologie

    Cologne, 50931

  • St. Elisabeth Hospital

    Cologne, 50935

  • Kliniken der Stadt Köln / Brustzentrum Holweide

    Cologne, 51067

  • DONAUISAR Klinikum

    Deggendorf, 94469

  • Klinikum Dortmund gGmbH

    Dortmund, 44137

  • St.-Johannes-Hospital Dortmund, Dept. of Obstetrics/Gynecology

    Dortmund, 44137

  • Onkologische Schwerpunktpraxis

    Dresden, 01067

  • University Hospital Dresden

    Dresden, 01069

  • Onkozentrum Dresden

    Dresden, 01127

  • Universitätsklinikum Düsseldorf, Klinik für Frauenheilkunde & Geburtshilfe

    Düsseldorf, 40225

  • Frauenklinik der Universität Erlangen

    Erlangen, 91054

  • Kliniken Essen-Mitte, Klinik für Senologie/ Interdisziplinäres Brustzentrum

    Essen, 45136

  • Universitätsklinikum Essen, Frauenklinik

    Essen, 45147

  • Klinikum Esslingen GmbH

    Esslingen am Neckar, 73730

  • Frankfurt University Department of Gynecology and Obstetrics

    Frankfurt, 60323

  • AGAPLESION Markus Krankenhaus

    Frankfurt am Main, 60431

  • Centrum for Haematology and Oncology

    Frankurt Am Main, 60389

  • Universitätsklinik Freiburg, Klinik für Frauenheilkunde

    Freiburg im Breisgau, 79106

  • Evangelische Kliniken Gelsenkirchen

    Gelsenkirchen, 45879

  • MVZ II der Niels-Stensen-Kliniken

    Georgsmarienhütte, 49074

  • SRH Waldklinikum Gera, Brustzentrum Ostthüringen

    Gera, 07548

  • MVZ Onkologische Kooperation Harz

    Goslar, 38642

  • Krankenhaus St. Elisabeth und St. Barbara Halle/Saale

    Halle, 06110

  • University Medical Center

    Hamburg, 20251

  • Mammazentrum HH am Krankenhaus Jerusalem

    Hamburg, 20357

  • Albertinen Krankenhaus

    Hamburg, 22457

  • Gynäkologisch-Ontologische Praxis Hannover

    Hanover, 30177

  • DIAKOVERE Henriettenstift Frauenklinik

    Hanover, 30559

  • Gemeinschaftspraxis Frauenärzte am Bahnhofsplatz

    Hildesheim, 31134

  • Department of Gyencology and Obstetrics, Saarland University Hospital

    Homburg, 66424

  • ViDia Christliche Kliniken Karlsruhe

    Karlsruhe, 76199

  • Elisabethkrankenhaus Kassel, Brustzentrum

    Kassel, 34117

  • Klinikum Kassel

    Kassel, 34125

  • University Hospital Schleswig-Holstein

    Kiel, 24105

  • Institut für Versorgungsforschung in der Onkologie

    Koblenz, 56068

  • St. Vincenz KH Limburg

    Limburg, 65549

  • UKSH Campus Lübeck

    Lübeck, 23562

  • Universitäts-Frauenklinik

    Magdeburg, 69120

  • Department of Obstetrics and Gynecology

    Mainz, 55131

  • Medzinische Fakultät Mannheim, Universität Heidelberg

    Mannheim, 68167

  • Klinikum Memmingen

    Memmingen, 87700

  • Johannes Wesling Klinikum Minden, Hämatologie-Onkologie/Brustzentrum

    Minden, 32429

  • Brustzentrum Niederrhein

    Mönchengladbach, 41061

  • Rotkreuzklinikum München, Frauenklinik

    München, 80637

  • Medizinisches Versorgungszentrum für Hämatologie und Onkologie München MVZ GmbH

    München, 80639

  • LMU Klinikum/ Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

    München, 81377

  • Gynaekologie Arabella

    Munich, 81925

  • Dept. OB/GYN Johanna Etienne Krankenhaus

    Neuss, 41462

  • Ortenau Klinikum Offenburg-Kehl

    Offenburg, 77694

  • Klinikum Oldenburg AöR

    Oldenburg, 26133

  • Frauenklinik St. Louise - St. Vincenz- Krankenhaus GmbH

    Paderborn, 33098

  • Klinikum Ernst von Bergmann

    Potsdam, 14467

  • Studienzentrum Onkologie Ravensburg

    Ravensburg, 88212

  • Oncologianova GmbH

    Recklinghausen, 45659

  • RoMed Klinikum Rosenheim

    Rosenheim, 83022

  • Univ-Hospital, Dept Ob/Gyn

    Rostock, 18059

  • CaritasKlinikum St. Theresia

    Saarbrücken, 66113

  • Onkologische Schwerpunktpraxis Speyer

    Speyer, 67346

  • G.SUND Gynäkologie Kompetenzzentrum

    Stralsund, 18435

  • KKH Torgau

    Torgau, 04860

  • Klinikum Mutterhaus

    Trier, 54290

  • Praxisnetzwerk Hämatologie/Internistische Onkologie

    Troisdorf, 53840

  • Frauenklinik

    Tübingen, 91054

  • Universitätsfrauenklinik Ulm

    Ulm, 89081

  • Schwarzwald - Baar Klinikum Frauenklinik

    Villingen-Schwenningen, 78052

  • Harzklinikum Dorothea Christiane Erxleben

    Wernigerode, 06484

  • St. Anna Hospital Brustzentrum

    Witten, 44649

  • Klinikum Worms gGmbH

    Worms, 67550

Other trials in Germany

Spain50 sites

  • Complejo Hospitalario Universitario A Coruña (CHUA)

    A Coruña, 15006

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, 28922

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital de San Juan de Alicante

    Alicante, 03550

  • Hospital Universitario de Badajoz

    Badajoz

  • Hospital del Mar

    Barcelona, 08003

  • IOB Institute Of Oncology-Hospital Quironsalud Barcelona

    Barcelona, 08023

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Universitari Mútua Terrassa

    Barcelona, 08221

  • ALTHAIA, Xarxa Assistencial Universitària de Manresa F.P.

    Barcelona, 08243

  • Hospital de Mataró

    Barcelona, 08304

  • ICO Hospitalet

    Barcelona, 08907

  • ICO Badalona

    Barcelona, 2050

  • Hospital Universitario de Basurto

    Bilbao, Bizkaia, 48013

  • Hospital Universitario San Pedro de Alcantara

    Cáceres, 10001

  • Consorcio Hospitalario Provincial de Castelló

    Castellon, 12002

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120

  • ICO Girona

    Girona, 17007

  • Hospital Universitario Clínico San Cecilio

    Granada, 18016

  • Complejo Hospitalario de Jaen

    Jaén, 23007

  • Complejo Asistencial Universitario de León

    León, 24001

  • Hospital Arnau de Vilanova de Lleida

    Lleida, 25198

  • Clinica Universidad De Navarra, Madrid

    Madrid, 28027

  • Hospital MD Anderson Cancer Center Madrid

    Madrid, 28033

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • HM Sanchinarro (CIOCC)

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Madrid, 28222

  • Hospital Universitario HM Puerta del Sur

    Madrid, 28938

  • Hospital Universitario de Fuenlabrada

    Madrid, 28942

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario Rey Juan Carlos

    Móstoles, 28933

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Complejo Hospitalario de Navarra

    Navarro, 31008

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120

  • Hospital Son Llatzer

    Palma de Mallorca, 07198

  • Hospital Universitario Sant Joan Reus

    Reus, Tarragona, 43204

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, 38320

  • Hospital General de Catalunya

    Sant Cugat del Vallès, 08195

  • Complejo Hospitalario Clínico Universitario de Santiago de Compostela (CHUS)

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Quirón Salud Sagrado Corazón

    Seville, 41013

  • Hospital Universtiario Virgen del Rocio

    Seville, 41013

  • Fundación Instituto Valenciano de Oncologia (IVO)

    Valencia, 46009

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Arnau de Vilanova de Valencia

    Valencia, 46015

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Japan24 sites

  • Hyogo Cancer Center

    Akashi, 673-8558

  • National Cancer Center (NCC) - Tsukiji Campus - National Cancer Center Hospital (NCCH)

    Chūōku, 104-0045

  • National Hospital Organization - National Kyushu Cancer Center

    Fukuoka, 811-1395

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518

  • Tokai University Hospital - Isehara Campus

    Isehara, 253-0036

  • Sagara Hospital

    Kagoshima, 892-0833

  • National Cancer Center Hospital East (NCCHE) - Kashiwa Campus

    Kashiwa, 277-8577

  • Japanese Foundation for Cancer Research (JFCR) - The Cancer Institute Hospital - Breast Oncology Center

    Kōtoku, 135-8550

  • Kyoto University Hospital

    Kyoto, 606-8507

  • National Hospital Organization (NHO) - Shikoku Cancer Center

    Matsuyama, 791-0280

  • Aichi Cancer Center Hospital

    Nagoya, 464-8681

  • Niigata Cancer Center Hospital

    Niigata, 951-8133

  • Hyogo Medical University Hospital

    Nishinomiya, 663-8501

  • Okayama University Hospital

    Okayama, 700-8558

  • National Hospital Organization - Osaka National Hospital (ONH)

    Osaka, 540-0006

  • Osaka International Cancer Institute (OICI)

    Osaka, 541-8567

  • Saitama Cancer Center

    Saitama, 362-0806

  • Kindai University (Kinki University) - Faculty of Medicine (Kinki University School of Medicine (KUSM)) - Kindai University Hospital (Kinki University Hospital) - Cancer Center

    Sakai, 590-0197

  • National Hospital Organization - Hokkaido Cancer Center

    Sapporo, 003-0804

  • Tohoku University Hospital (TUH) - Clinical Research, Innovation and Education Center (CRIETO)

    Sendai, 980-8574

  • Showa Medical University Hospital - Breast Center

    Shinagawa-Ku, 1428666

  • Tokyo Medical University Hospital

    Shinjuku-Ku, 160-0023

  • Shizuoka Cancer Center (SCC)

    Shizuoka, 411-8777

  • Kanagawa Cancer Center Hospital - Kanagawa Cancer Center (Kanagawa Cancer Centre Research Institute)

    Yokohama, 241-8515

Other trials in Japan

France21 sites

  • Clinique Tivoli Ducos - Centre dOncologie et de Radiotherapie a Bordeaux

    Bordeaux, Gironde, 33000

  • Institut Bergonie

    Bordeaux, 33000

  • Centre Georges François Leclerc

    Dijon, 21000

  • CHD Vendee

    La Roche-sur-Yon, 85925 cedex 9

  • Centre Hosp Univ de Grenoble CHUG

    La Tronche, 38700

  • Centre Oscar Lambret

    Lille, 59000

  • Centre Leon Berard

    Lyon, 69008

  • Institut Paoli-Calmettes

    Marseille, 13009

  • CHR Metz-Thionville

    Metz, Lorraine, 57085

  • Centre de Cancérologie du Grand Montpellier

    Montpellier, 34070

  • The Sel of Centre dOncologie de Gentilly

    Nancy, 54000

  • Centre Antoine Lacassagne

    Nice, 6189

  • Hospital St Louis

    Paris, 75010

  • Hopital Georges Pompidou

    Paris, 75015

  • IUC AP-HP. Sorbonne Université, Hôpital Tenon

    Paris, 75020

  • CHU de Poitiers

    Poitiers, 86021

  • Centre Eugene Marquis

    Rennes, 35042

  • Institut de cancerologie de l'ouest

    Saint-Herblain, 44360

  • Institut De Cancerologie De La Loire

    Saint-Priest-en-Jarez, Pays de la Loire Region, 42270

  • Strasbourg Europe Cancer Institute

    Strasbourg, 67033

  • Institut Claudius Regaud

    Toulouse, Haute Garonne, 31059

Other trials in France

Italy20 sites

  • Clinica Oncologica, Ospedali Riuniti Umberto 1

    Ancona, 60126

  • Centro di Riferimento Oncologico di Aviano - SOC Oncologia Medica e Prevenzione Oncologica

    Aviano, 33081

  • Istituto Oncologico di Bari

    Bari, 70124

  • Azienda ULSS n. 1 Dolomiti

    Belluno, 32100

  • Policlinico S.Orsola-Malpighi SSD Oncologia Medica Addarii

    Bologna, 40138

  • SSD Oncologia Medica

    Bologna, 40138

  • Presidio Ospedaliero di Summa - Antonio Perrino

    Brindisi, 72100

  • Istituto di Candiolo - IRCCS

    Candiolo, 10060

  • Azienda Ospedaliera Garibaldi-Nesima

    Catania, CT, 95122

  • Ospedale Poli SAN MARTINO

    Genova, 16132

  • Area Vasta Sud Est Sede Operativa Grosseto

    Grosseto, 58100

  • Azienda Usl Toscana sud est

    Grosseto, 58100

  • Istituto Europeo di Oncologia

    Milan, MI, 20141

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • University Hospital of Modena

    Modena, 41122

  • INT Fondazione Pascale

    Naples, 80131

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128

  • ICS Maugeri IRCCS

    Pavia, 27100

  • Azienda Ospedaliera di Perugia

    Perugia, 06132

  • A.O.U. Citta della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

China17 sites

  • Peking University Cancer Hospital

    Beijing, 100142

  • Peking University Third Hospital

    Beijing, 100191

  • Jilin University JLU - First Affiliated Hospital

    Changchun, 19512

  • Sichuan University - West China Hospital

    Chengdu, 610041

  • Chongqing Medical University - The First Affiliated Hospital

    Chongqing, 400016

  • Union Hospital of Fujian Medical University

    Fuzhou, 35001

  • Sun Yat-sen Memorial Hospital

    Guangzhou, 510030

  • Guangdong Academy of Medical Science

    Guangzhou, 510080

  • Zhejiang Cancer Hospital

    Hangzhou, 310002

  • Second Affiliated Hospital of Zhejiang University

    Hangzhou, 310009

  • Harbin Medical University Cancer Hospital

    Harbin, 150060

  • Shandong Cancer Hospital

    Jinan, 250117

  • Nanchang University - The First Affiliated Hospital

    Nanchang, 330006

  • Nanjing Medical University NMU - Jiangsu Province Hospital

    Nanjing, 210029

  • Fudan University Cancer Hospital

    Shanghai, 200032

  • The 4th Hospital of Heibei Medical University

    Shijiazhuang, 50011

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003

Other trials in China

United Kingdom16 sites

  • Royal United Hospital Bath NHS Trust - Royal United Hospital RUH

    Bath, Somerset, BA1 3NG

  • Univeristy Hospitals Bristol NHS Foundation Trust

    Bristol, BS2 8ED

  • Colchester Hospital, East Suffolk & North Essex NHS Foundation Trust

    Colchester, CO4 5JL

  • Royal Devon Exeter NHS Foundation Trust

    Exeter, EX2 5DW

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • St. James University Hospital

    Leeds, West Yorkshire, LS9 7TF

  • Guys and St Thomas NHS Foundation Trust

    London, SE1 9RT

  • Charing Cross Hospital

    London, W6 8RF

  • Kent Oncology Centre Maidstone Hospital

    Maidstone, Kent, ME16 9QQ

  • The Christie Hospital

    Manchester, Lancashire, M20 4XB

  • Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, Merseyside, CH63 4JY

  • Nottingham University Hospitals

    Nottingham, Nottinghamshire, NG5 1PB

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LJ

  • Peterborough City Hospital

    Peterborough, Cambridgeshire, PE3 9NZ

  • Blackpool Victoria Hospital

    Peterborough, FY3 8NR

  • Somerset NHS Foundation Trust

    Taunton, Somerset, TA1 5DA

Other trials in United Kingdom

Taiwan13 sites

  • Koo Foundation Sun Yat-Sen Cancer Center

    Beitou, 112

  • Changhua Christian Hospital (CCH)

    Chang-hua, 50006

  • E-Da Cancer Hospital

    Kaohsiung City, Yanchao District, 82445

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704

  • Chi Mei Medical Center CMMC - Yongkang Branch

    Tainan, 71004

  • National Taiwan University Hospital NTUH

    Taipei, 10002

  • MacKay Memorial Hospital

    Taipei, 10449

  • Taipei Veterans General Hospital TPVGH

    Taipei, 111217

  • Tri-Service General Hospital

    Taipei, 114

  • Chang Gung Memorial Hospital CGMH

    Taipei, 33305

Other trials in Taiwan

South Korea11 sites

  • Kyungpook National University Hospital

    Daegu, 41944

  • National Cancer Center

    Gyeonggi-do, 10408

  • CHA Bundang Medical Center CHA University

    Gyeonggi-do, 13496

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Samsung Medical Center

    Irwon-dong, 06351

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Songpa-gu, 05505

  • Soon Chun Hyang Central Medical Center (SCHMC)

    Yongsan, 330-721

Other trials in South Korea

Portugal10 sites

  • Hospital da Senhora da Oliveira, Guimarães EPE

    Guimarães, 4835-044

  • Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE

    Lisbon, 1099-023

  • Fundação Champalimaud

    Lisbon, 1400-038

  • Centro Hospitalar de Lisboa Ocidental, EPE

    Lisbon, 1449-005

  • Hospital da Luz

    Lisbon, 1500-650

  • Hospital CUF Descobertas

    Lisbon, 1998-018

  • Hospital Beatriz Ângelo

    Loures, 2674-514

  • Unidade Local de Saúde de Matosinhos, EPE

    Matosinhos Municipality, 4464-513

  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Australia9 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Chris O Brien Lifehouse

    Camperdown, 2050

  • Monash Health

    Clayton, 3168

  • Austin Hospital- Olivia Newto-John Cancer and Wellness Centre

    Heidelberg, 3804

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

  • Breast Cancer Research Centre - WA

    Nedlands, 6009

  • Genesis Care Northern Cancer

    Saint Leonards, 2065

  • St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC)

    Subiaco, 2050

  • Southern Medical Day Care Centre

    Wollongong, 2500

Other trials in Australia

Brazil9 sites

  • Fundacao Pio XII-Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Hospital Sirio-Libanes HSL - Centro de Oncologia - Brasilia

    Brasília, Federal District, 70200-730

  • Fundação Universidade de Caxias do Sul Instituto de Pesquisas em Saúde IPS-UCS

    Caxias do Sul, Rio Grande do Sul, 95070-560

  • Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

  • Hospital Sao Lucas PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • INCA - Instituto Nacional do Cancer / Hospital do Cancer HCIII

    Rio de Janeiro, 20560-120

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

    Santo André, São Paulo, 09060-650

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15092415

  • Instituto do Cancer do Estado de Sao Paulo (ICESP)

    São Paulo, 01246-000

Other trials in Brazil

Belgium8 sites

  • Algemeen Ziekenhuis AZ Klina - Borstkliniek

    Brasschaat, 2930

  • Institut Jules Bordet Brussels Belgium

    Brussels, 1000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Antwerp University Hospital

    Edegem, Antwerpen, 2650

  • UZ Gent

    Ghent, O. VL., 9000

  • UZ Leuven - Campus Gasthuisberg

    Leuven, 3000

  • CHU Liege

    Liège, 4000

  • GZA Hospitals Campus Sint- Augustinus

    Wilrijk, 2610

Other trials in Belgium

Canada7 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N4N2

  • CIUSSSS de l'Est-de-l'Ile-de-Montréal - Installation Hôpital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • CHUM

    Montreal, Quebec, H2X3E4

  • Jewish General Hospital Segal Cancer Centre

    Montreal, Quebec, H3T1E2

  • McGill University Health Centre - Cedars Cancer Centre

    Montreal, Quebec, H4A 3J1

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • CHU de Quebec - Hopital du Saint-Sacrement

    Québec, Quebec, G1S 4L8

Other trials in Canada

Argentina6 sites

  • COIBA

    Buenos Aires, B1884BBF

  • Instituto Alexander Fleming

    Caba, 1426

  • Centro Oncologico Riojano Integral

    Capital, La Rioja Province, 5300

  • Sanatorio Británico de Rosario

    Rosario, Santa Fe Province, 2000

  • Instituto de Oncología de Rosario

    Rosario, Santa Fe Province, S2000KZE, 2457

  • CER San Juan

    San Juan, 5400

Other trials in Argentina

Denmark5 sites

  • Aalborg University Hospital

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus, 8210

  • Rigshospitalet

    Copenhagen, 2100

  • Odense University Hospital

    Odense, 5000

  • Soenderborg sygehus

    Syddanmark, 6400

Other trials in Denmark

Greece5 sites

  • Aretaieio Hospital

    Athens, Attica, 11528

  • General Hospital of Athens Alexandra Clinic

    Athens, Attica, 11528

  • University General Hospital of Heraklion

    Heraklion, Crete, 71110

  • University General Hospital of Patras

    Pátrai, West Greece, 265 04

  • General Hospital of Patras Agios Andreas

    Pátrai, 26335

Other trials in Greece

Ireland5 sites

  • University College Cork

    Cork, T12 YN60

  • Saint Vincents University Hospital

    Dublin, IE-D, 4

  • St. James Hospital

    Dublin, Leinster, D8

  • Mater Misericordiae University Hospital

    Dublin, 7

  • University Hospital Limerick

    Limerick, V94 F858

Other trials in Ireland

Poland5 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-211

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338

  • SP Zoz Opolskie Centrum Onkologii IM

    Opole, Opole Voivodeship, 45-061

  • Centrum Medyczne HCP Sp. z o.o.

    Poznan, Greater Poland Voivodeship, 61-485

  • MSCM Cancer Center and Institute of Oncology Department of Breast Cancer and Reconstructive Surgery

    Warsaw, 02-781

Other trials in Poland

Israel4 sites

  • Soroka MC

    Beersheba, Southern District, 8410101

  • Hadassah Medical Center

    Jerusalem, 91120

  • Rabin Medical Center

    Petah Tikva, 49100

  • Sheba Medical Center

    Ramat Gan, Tel Aviv, 5262100

Other trials in Israel

Peru4 sites

  • Hospital Nacional Arzobispo Loayza

    Lima, 15082

  • Clinica Ricardo Palma

    Lima, Lima 27

  • Instituto Nacional de Enfermedades Neoplasicas INEN

    Lima, Lima 34

  • Centro de Investigación Clinica Trujillo EIRL

    Trujillo, 13001

Other trials in Peru

Romania4 sites

  • Institutul Oncologic Bucuresti IOB

    Bucharest, 22328

  • Institutul Oncologic Prof. Dr. Ion Chiricuta

    Cluj-Napoca, Cluj, 400015

  • Onco Clinic Consult SA

    Craiova, Dolj, 200103

  • Centrul de Oncologie Sfantu Nectarie

    Craiova, Dolj, 200347

Other trials in Romania

Turkey (Türkiye)4 sites

  • Hacettepe University Cancer Institute

    Ankara, İç Anadolu, 6100

  • Trakya University Medical Faculty

    Edirne, 22030

  • Istanbul Medeniyet University Medical Faculty

    Istanbul, 34093

  • Medical Park - Izmir Hastanesi

    Izmir, 35575

Other trials in Turkey (Türkiye)

Chile3 sites

  • Hospital Clinico Universidad de Chile

    Santiago, RM, 8380456

  • Fundacion Arturo Lopez Perez

    Santiago, 7500921

  • SIM CRC

    Temuco, 4780000

Other trials in Chile

Hong Kong3 sites

  • Pamela Youde Nethersole Eastern Hospital PYNEH

    Hong Kong, 10101

  • The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH)

    Hong Kong, 999077

  • The University of Hong Kong (HKU) - Queen Mary Hospital (QMH)

    Pok Fu Lam, 10101

Other trials in Hong Kong

Mexico3 sites

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, Jalisco, 44280

  • Consultorio del Dr. Joaqun Gabriel Reinoso Toledo

    Monterrey, Nuevo León, 64320

  • CIMAB S.A. de C.V

    Torreón, Coahuila, 27000

Other trials in Mexico

Netherlands3 sites

  • Amsterdam UMC - VU Medisch Centrum

    Amsterdam, North Holland, 1081 HZ

  • Amphia Hospital Breda

    Breda, 4800 RK

  • Erasmus MC - Daniel den Hoed Oncologisch Centrum

    Rotterdam, 3000 CA

Other trials in Netherlands

Czechia2 sites

  • University Hospital Brno

    Brno, 62500

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 10034

Other trials in Czechia

Russia2 sites

  • SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary

    Arkhangelsk, 163045

  • State Budgetary Healthcare Institution Oncological Dispensary No. 2 of the Ministry of Health of Krasnodar Region

    Sochi, 354057

Other trials in Russia

Singapore2 sites

  • National University Cancer Institute

    Singapore, 119074

  • National Cancer Center Singapore

    Singapore, 169610

Other trials in Singapore

About this study

Official title: 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.

Read the 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).

Being tested
DS-8201a, T-DM1
Keywords
HER2-Positive Primary Breast Cancer, Residual Invasive Breast Cancer, Trastuzumab Deruxtecan, Trastuzumab Emtansine

What participants receive

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

  • DS-8201aDrug

    Also called Trastuzumab deruxtecan (T-DXd)

    Administered initially as an intravenous (IV) infusion at a dose of 5.4 mg/kg on Day 1 of each 21-day cycle

  • T-DM1Drug

    Also called Trastuzumab emtansine (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

Study groups in NCT04622319
Study groupRoleWhat they receive
Trastuzumab deruxtecan (T-DXd)ExperimentalParticipants who will be randomized to receive trastuzumab deruxtecan (T-DXd) at a starting dose of 5.4 mg/kg.
Receives: Drug: DS-8201a
Trastuzumab ematansine (T-DM1)Active comparatorParticipants who will be randomized to receive trastuzumab ematansine (T-DM1) at a starting dose of 3.6 mg/kg.
Receives: Drug: T-DM1

What is being measured

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

  1. Invasive Disease-free Survival (IDFS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment

    Measured: 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 outcomes (7)

  1. Disease-free Survival (DFS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment

    Measured: 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

  2. Overall Survival (OS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment

    Measured: Randomization to date of death from any cause, up to approximately 81 months postdose

  3. Distant Recurrence-free Interval (DRFI) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment

    Measured: Randomization to date of distant recurrence, up to approximately 81 months postdose

  4. Brain Metastases-free Interval (BMFI) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment

    Measured: Randomization to date of brain metastasis, up to approximately 81 months postdose

  5. Percentage of Treatment-emergent Adverse Events in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment

    Measured: Baseline up to approximately 81 months postdose

  6. Serum Concentrations of Trastuzumab Deruxtecan (T-DXd), total anti-HER2 antibody, and Active Metabolite MAAA-1181a

    Measured: 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)

  7. Percentage of Participants Positive for Treatment-emergent Anti-drug Antibodies (ADAs) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd)

    Measured: Baseline up to approximately 81 months postdose

Timeline

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

  1. First posted9 Nov 2020
  2. Study start4 Dec 2020
  3. Primary completion2 Jul 2025
  4. Study completion20 Jun 2028 (estimated)

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
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04622319
Sponsor's protocol ID
DS8201-A-U305
Other IDs
2020-003982-20, DESTINY-Breast05, NSABP B-60, GBG-103, SOLTI-2001
Status last verified
May 2026
First submitted
2 Nov 2020
Last updated
15 May 2026
Results posted
No
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

  • Loibl S, Park YH, Shao Z, Huang CS, Barrios C, Abraham J, Prat A, Niikura N, Im SA, Li W, Li H, Wang Y, Yao H, Kim SB, Geng CZ, Rodriguez Pantigoso W, Ramirez Godinez FJ, Song C, Ching Chang Y, Antoniazzi A, Chen SC, Li Z, Nowecki Z, Lim J, Mathias E, Sato Y, Lu W, Abdel-Monem H, Untch M, Geyer CE Jr; DESTINY-Breast05 Trial Investigators. Trastuzumab Deruxtecan in Residual HER2-Positive Early Breast Cancer. N Engl J Med. 2026 Feb 26;394(9):845-857. doi: 10.1056/NEJMoa2514661. Epub 2025 Dec 10.

    PubMed 41370739

  • Boman C, Tranchell C, Liu X, Eriksson Bergman L, Toli MA, Bergh J, Foukakis T, Matikas A. Prognosis After Pathologic Complete Response to Neoadjuvant Therapy in Early-Stage Breast Cancer: A Population-Based Study. J Natl Compr Canc Netw. 2025 Mar 12;23(4):e247093. doi: 10.6004/jnccn.2024.7093.

    PubMed 40073831

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DS-8201a and T-DM1 in people with HER2-Positive Primary Breast Cancer and Residual Invasive Breast Cancer, run by Daiichi Sankyo at 482 sites in 31 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 17 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: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 482 sites in United States, Germany, Spain, Japan, France and 26 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?

This study is still under way. Results are not available in the source record yet.

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?

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). 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 NCT04622319, 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 15 May 2026.

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