Clinical trials›HER2-Positive Primary Breast Cancer›Injection›Trial details
ActiveComing Soon (1–3 yrs) Treatment Study

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)

For Condition: HER2-Positive Primary Breast CancerFor Condition: Residual Invasive Breast Cancer

ID: NCT04622319

Horizon Patient Guidance Summary

Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:

How it’s taken
Injections / IV Shots
Expected Availability Horizon
Coming Soon (1–3 yrs away)
StageAdvanced Clinical Stage : Large-scale testing in thousands of patients. The final benchmark comparison phase closest to FDA approval and commercial release.
EligibleThis study is looking exclusively for patients diagnosed with the condition.
About This Clinical Trial

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 Full Scientific Objectives & Methods

This study will examine trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive primary BC who have residual invasive disease in breast or axillary lymph nodes with higher risk of recurrence, which includes patients who were inoperable at disease presentation or had pathological node-positive status after neoadjuvant therapy. The primary objective is to compare invasive disease-free survival (IDFS) between T-DXd and T-DM1 treatment arms in this population. The key secondary objective of the study is to evaluate disease-free survival (DFS).

Study Timeline & Quick Facts
Trial Status
In Progress (Not Taking New Patients)
Total Target Enrollment
1.6K patients (Estimated)
Study Start Date
2020-12-04
Est. Primary Completion
2025-07-02
Tested Drugs & Treatment Groups
DRUGDS-8201a

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

DRUGT-DM1

Administered initially as an intravenous (IV) infusion at a dose of 3.6 mg/kg on Day 1 of each 21-day cycle

Treatment Arms Description

EXPERIMENTALTrastuzumab deruxtecan (T-DXd)

Participants who will be randomized to receive trastuzumab deruxtecan (T-DXd) at a starting dose of 5.4 mg/kg.

ACTIVE_COMPARATORTrastuzumab ematansine (T-DM1)

Participants who will be randomized to receive trastuzumab ematansine (T-DM1) at a starting dose of 3.6 mg/kg.

Can I Join This Study?
Suitable For
Everyone welcome
Ages Welcome
18 Years and older
Full Criteria Checklist
Who Can 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:
  • 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
  • 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.
What is this Study Measuring?

Primary Outcome Measures

  • 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
View Secondary Outcome Measures (7)
  • Disease-free Survival (DFS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment — Time Frame: Randomization to date of the first occurrence of an IDFS event including second primary non-breast cancer event or contralateral or ipsilateral ductal carcinoma in situ (whichever occurs first), up to approximately 81 months postdose
  • Overall Survival (OS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment — Time Frame: Randomization to date of death from any cause, up to approximately 81 months postdose
  • Distant Recurrence-free Interval (DRFI) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment — Time Frame: Randomization to date of distant recurrence, up to approximately 81 months postdose
  • Brain Metastases-free Interval (BMFI) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment — Time Frame: Randomization to date of brain metastasis, up to approximately 81 months postdose
  • Percentage of Treatment-emergent Adverse Events in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment — Time Frame: Baseline up to approximately 81 months postdose
  • Serum Concentrations of Trastuzumab Deruxtecan (T-DXd), total anti-HER2 antibody, and Active Metabolite MAAA-1181a — Time Frame: Pre-dose on Day 1 of Cycles 1, 4 and 10 and within 15 minutes post-dose on Day 1 of Cycles 1 and 4 (each cycle is 21 days)
  • Percentage of Participants Positive for Treatment-emergent Anti-drug Antibodies (ADAs) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) — Time Frame: Baseline up to approximately 81 months postdose
Where to Participate

This trial is recruiting at 482 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:

Show All 482 Facilities & Contact Sites
The Oncology Institute of Hope & Innovation
Anaheim, California, United States
Kaiser Permanente
Anaheim, California, United States
Kaiser Permanente
Baldwin Park, California, United States
Kaiser Permanente
Bellflower, California, United States
Kaiser Permanente
Fontana, California, United States
Orange Coast Blood and Cancer Care
Fountain Valley, California, United States
Kaiser Permanente
Harbor City, California, United States
Kaiser Permanente
Irvine, California, United States
Long Beach Memorial TCI
Long Beach, California, United States
Kaiser Permanente
Los Angeles, California, United States
Kaiser Permanente
Ontario, California, United States
Kaiser Permanente
Panorama City, California, United States
Kaiser Permanente
Riverside, California, United States
Kaiser Permanente
San Diego, California, United States
Kaiser Permanente
San Marcos, California, United States
Kaiser Permanente
West Los Angeles, California, United States
Kaiser Permanente
Woodland Hills, California, United States
SCRI FCS North- Altamonte
Altamonte Springs, Florida, United States
SCRI FCS South- Bonita
Bonita Springs, Florida, United States
SCRI FCS North- Brandon Cancer Center
Brandon, Florida, United States
SCRI FCS South- North Fort Myers
Cape Coral, Florida, United States
SCRI FCS North- Mease/Clearwater
Clearwater, Florida, United States
SCRI FCS South
Fort Myers, Florida, United States
SCRI FCS South- Colonial
Fort Myers, Florida, United States
SCRI FCS South- Gladiolus
Fort Myers, Florida, United States
SCRI FCS North- Gainesville Cancer Center
Gainesville, Florida, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
SCRI FCS North- Villages East
Lady Lake, Florida, United States
SCRI FCS South- Lakewood Ranch
Lakewood Rch, Florida, United States
SCRI FCS North- Largo/Highland
Largo, Florida, United States
SCRI FCS North- Lecanto
Lecanto, Florida, United States
SCRI FCS South- Naples West
Naples, Florida, United States
SCRI FCS South- Naples/Goodlette
Naples, Florida, United States
SCRI FCS North- New Port Richey
New Port Richey, Florida, United States
SCRI FCS North- Ocala
Ocala, Florida, United States
Orlando Health
Ocoee, Florida, United States
SCRI FCS North- Orange City
Orange City, Florida, United States
Orlando Health
Orlando, Florida, United States
SCRI FCS North- Orlando Downtown
Orlando, Florida, United States
SCRI FCS South- Port Charlotte
Port Charlotte, Florida, United States
SCRI FCS South- Sarasota-Cattleman
Sarasota, Florida, United States
SCRI FCS South-Sarasota-Downtown
Sarasota, Florida, United States
SCRI FCS North- Spring Hill
Spring Hill, Florida, United States
SCRI FCS North- St. Anthony's/St. Petersburg
St. Petersburg, Florida, United States
SCRI FCS North
St. Petersburg, Florida, United States
SCRI FCS North- Tampa Cancer Center
Tampa, Florida, United States
SCRI FCS North- Tavares
Tavares, Florida, United States
SCRI FCS South- Venice Healthpark
Venice, Florida, United States
Cleveland Clinic-Weston
Weston, Florida, United States
SCRI FCS North- Winter Park
Winter Park, Florida, United States
Elmhurst Memorial Hospital- Nancy W. Knowles Cancer Center
Elmhurst, Illinois, United States
Edward Cancer Center
Naperville, Illinois, United States
Edward Cancer Center Plainfield
Plainfield, Illinois, United States
University of Kentucky, Markey Cancer Center, Clinical Research Organization
Lexington, Kentucky, United States
Baptist Health Louisville
Louisville, Kentucky, United States
LSU Health Baton Rouge North Clinic
Baton Rouge, Louisiana, United States
Our Lady of the Lake Physician Group-Medical Oncology
Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Ochsner Hematology Oncology North Shore - Covington (West Region)
Covington, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
MedStar Franklin Square Medical Center-Harry and Jeanette Weinberg Cancer Institute
Baltimore, Maryland, United States
MedStar Franklin Square Cancer Center at Loch Raven Campus
Baltimore, Maryland, United States
Frederick Health-James M Stockman Cancer Center
Frederick, Maryland, United States
Maryland Oncology Hematology
Silver Spring, Maryland, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
Montefiore Medical Center
The Bronx, New York, United States
Waverly Hematology Oncology
Cary, North Carolina, United States
UNC Cancer Care at Nash
Rocky Mount, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Cleveland Clinic - Hillcrest
Cleveland, Ohio, United States
Cleveland Clinic-Fairview
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Cleveland Clinic South Pointe
Warrensville Heights, Ohio, United States
UPMC Upper St. Clair
Bethel Park, Pennsylvania, United States
UPMC Passavant Cranberry/North
Cranberry Township, Pennsylvania, United States
UPMC Erie
Erie, Pennsylvania, United States
AHN Cancer Inst at St Vincent
Erie, Pennsylvania, United States
UPMC Arnold Palmer-Mt View
Greensburg, Pennsylvania, United States
UPMC Pinnacle-Ortenzio Cancer Center
Harrisburg, Pennsylvania, United States
UMPC Pinnacle Pharmacy
Harrisburg, Pennsylvania, United States
AHN Cancer Insititute at Jefferson
Jefferson Hills, Pennsylvania, United States
AHN Cancer Institute at Forbes
Monroeville, Pennsylvania, United States
UPMC Monroeville
Monroeville, Pennsylvania, United States
UPMC Arnold Palmer-Mt Pleasant
Mount Pleasant, Pennsylvania, United States
UPMC Arnold Palmer-Norwin
N. Huntingdon, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Magee
Pittsburgh, Pennsylvania, United States
UPMC St. Margaret
Pittsburgh, Pennsylvania, United States
AHN Cancer Inst at West Penn
Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
UPMC Passavant HOA
Pittsburgh, Pennsylvania, United States
UPMC Passavant OHA
Pittsburgh, Pennsylvania, United States
UPMC Uniontown
Uniontown, Pennsylvania, United States
UPMC Washington
Washington, Pennsylvania, United States
Reading Hospital, McGlinn Cancer Institute
West Reading, Pennsylvania, United States
AHN Cancer Institute at Wexford
Wexford, Pennsylvania, United States
UPMC Pinnacle-Memorial Cancer Center
York, Pennsylvania, United States
SCRI TO Nashville- Franklin Tennessee Oncology, PLLC
Franklin, Tennessee, United States
SCRI TO Nashville- Gallatin Tennessee Oncology, PLLC
Gallatin, Tennessee, United States
SCRI TO Nashville- Hendersonville Tennessee Oncology, PLLC
Hendersonville, Tennessee, United States
SCRI TO Nashville- Summit Tennessee Oncology, PLLC
Hermitage, Tennessee, United States
Regional Cancer Center at Indian Path Community Hospital
Kingsport, Tennessee, United States
SCRI TO Nashville- Lebanon Tennessee Oncology, PLLC
Lebanon, Tennessee, United States
SCRI TO Nashville- St. Thomas Midtown Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Tennessee Oncology Nashville / Sarah Cannon
Nashville, Tennessee, United States
SCRI TO Nashville- St. Thomas West Tennessee Oncology, PLLC
Nashville, Tennessee, United States
SCRI TO Nashville- Skyline Tennessee Oncology, PLLC
Nashville, Tennessee, United States
SCRI TO Nashville- Southern Hills Tennessee Oncology, PLLC
Nashville, Tennessee, United States
SCRI TO Nashville- Smyrna Tennessee Oncology, PLLC
Smyrna, Tennessee, United States
Houston Methodist Baytown
Baytown, Texas, United States
Houston Methodist
Houston, Texas, United States
Houston Methodist Willowbrook
Houston, Texas, United States
Houston Methodist West
Houston, Texas, United States
Houston Methodist Clear Lake
Nassau Bay, Texas, United States
Houston Methodist Sugarland
Sugar Land, Texas, United States
Houston Methodist Woodlands
The Woodlands, Texas, United States
Wellmont Medical Associates Oncology & Hematology
Bristol, Virginia, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
MultiCare Cancer Center Aurburn
Auburn, Washington, United States
MultiCare Regional Cancer Center - Gig Harbor
Gig Harbor, Washington, United States
MultiCare Cancer Center Puyallup
Puyallup, Washington, United States
MultiCare Institute for Research & Innovation
Spokane, Washington, United States
MultiCare Institute for Research & Innovation
Spokane, Washington, United States
MultiCare Cancer Center Tacoma
Tacoma, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Centro Oncologico Riojano Integral
Capital, La Rioja Province, Argentina
Sanatorio Británico de Rosario
Rosario, Santa Fe Province, Argentina
Instituto de Oncología de Rosario
Rosario, Santa Fe Province, Argentina
COIBA
Buenos Aires, Argentina
Instituto Alexander Fleming
Caba, Argentina
CER San Juan
San Juan, Argentina
Royal Adelaide Hospital
Adelaide, Australia
Chris O Brien Lifehouse
Camperdown, Australia
Monash Health
Clayton, Australia
Austin Hospital- Olivia Newto-John Cancer and Wellness Centre
Heidelberg, Australia
Peter MacCallum Cancer Centre
Melbourne, Australia
Breast Cancer Research Centre - WA
Nedlands, Australia
Genesis Care Northern Cancer
Saint Leonards, Australia
St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC)
Subiaco, Australia
Southern Medical Day Care Centre
Wollongong, Australia
Antwerp University Hospital
Edegem, Antwerpen, Belgium
UZ Gent
Ghent, O. VL., Belgium
Algemeen Ziekenhuis AZ Klina - Borstkliniek
Brasschaat, Belgium
Institut Jules Bordet Brussels Belgium
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
UZ Leuven - Campus Gasthuisberg
Leuven, Belgium
CHU Liege
Liège, Belgium
GZA Hospitals Campus Sint- Augustinus
Wilrijk, Belgium
Hospital Sirio-Libanes HSL - Centro de Oncologia - Brasilia
Brasília, Federal District, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Fundação Universidade de Caxias do Sul Instituto de Pesquisas em Saúde IPS-UCS
Caxias do Sul, Rio Grande do Sul, Brazil
Hospital Sao Lucas PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Pio XII-Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, São Paulo, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
INCA - Instituto Nacional do Cancer / Hospital do Cancer HCIII
Rio de Janeiro, Brazil
Instituto do Cancer do Estado de Sao Paulo (ICESP)
São Paulo, Brazil
Tom Baker Cancer Centre
Calgary, Alberta, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
CIUSSSS de l'Est-de-l'Ile-de-Montréal - Installation Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
CHUM
Montreal, Quebec, Canada
Jewish General Hospital Segal Cancer Centre
Montreal, Quebec, Canada
McGill University Health Centre - Cedars Cancer Centre
Montreal, Quebec, Canada
CHU de Quebec - Hopital du Saint-Sacrement
Québec, Quebec, Canada
Hospital Clinico Universidad de Chile
Santiago, RM, Chile
Fundacion Arturo Lopez Perez
Santiago, Chile
SIM CRC
Temuco, Chile
Peking University Cancer Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Jilin University JLU - First Affiliated Hospital
Changchun, China
Sichuan University - West China Hospital
Chengdu, China
Chongqing Medical University - The First Affiliated Hospital
Chongqing, China
Union Hospital of Fujian Medical University
Fuzhou, China
Sun Yat-sen Memorial Hospital
Guangzhou, China
Guangdong Academy of Medical Science
Guangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Second Affiliated Hospital of Zhejiang University
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Shandong Cancer Hospital
Jinan, China
Nanchang University - The First Affiliated Hospital
Nanchang, China
Nanjing Medical University NMU - Jiangsu Province Hospital
Nanjing, China
Fudan University Cancer Hospital
Shanghai, China
The 4th Hospital of Heibei Medical University
Shijiazhuang, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
University Hospital Brno
Brno, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
Soenderborg sygehus
Syddanmark, Denmark
Clinique Tivoli Ducos - Centre dOncologie et de Radiotherapie a Bordeaux
Bordeaux, Gironde, France
Institut Claudius Regaud
Toulouse, Haute Garonne, France
CHR Metz-Thionville
Metz, Lorraine, France
Institut De Cancerologie De La Loire
Saint-Priest-en-Jarez, Pays de la Loire Region, France
Institut Bergonie
Bordeaux, France
Centre Georges François Leclerc
Dijon, France
CHD Vendee
La Roche-sur-Yon, France
Centre Hosp Univ de Grenoble CHUG
La Tronche, France
Centre Oscar Lambret
Lille, France
Centre Leon Berard
Lyon, France
Institut Paoli-Calmettes
Marseille, France
Centre de Cancérologie du Grand Montpellier
Montpellier, France
The Sel of Centre dOncologie de Gentilly
Nancy, France
Centre Antoine Lacassagne
Nice, France
Hospital St Louis
Paris, France
Hopital Georges Pompidou
Paris, France
IUC AP-HP. Sorbonne Université, Hôpital Tenon
Paris, France
CHU de Poitiers
Poitiers, France
Centre Eugene Marquis
Rennes, France
Institut de cancerologie de l'ouest
Saint-Herblain, France
Strasbourg Europe Cancer Institute
Strasbourg, France
Gemeinschaftspraxis Dres. Halder / Bangerter
Augsburg, Germany
Cahrité Campus Mitte
Berlin, Germany
Praxis Dr. med. J. Schilling
Berlin, Germany
MediOnko-Institut GbR, Praxisklinik Krebsheilkunde
Berlin, Germany
DRK Kliniken Berlin Köpenick
Berlin, Germany
Helios Klinikum Berlin-Buch
Berlin, Germany
Onkologische Schwerpunktpraxis
Berlin, Germany
Onkologische Schwerpunktpraxis
Bielefeld, Germany
Klinikverbund Südwest Kliniken Böblingen Frauenklinik Böblingen
Böblingen, Germany
Studien GbR Braunschweig
Braunschweig, Germany
Klinikum Bremen Mitte
Bremen, Germany
Frauenklinik DIAKO Bremen
Bremen, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Unifrauenklinik Köln - Studienzentrum Gynäkologie
Cologne, Germany
St. Elisabeth Hospital
Cologne, Germany
Kliniken der Stadt Köln / Brustzentrum Holweide
Cologne, Germany
DONAUISAR Klinikum
Deggendorf, Germany
Klinikum Dortmund gGmbH
Dortmund, Germany
St.-Johannes-Hospital Dortmund, Dept. of Obstetrics/Gynecology
Dortmund, Germany
Onkologische Schwerpunktpraxis
Dresden, Germany
University Hospital Dresden
Dresden, Germany
Onkozentrum Dresden
Dresden, Germany
Universitätsklinikum Düsseldorf, Klinik für Frauenheilkunde & Geburtshilfe
Düsseldorf, Germany
Frauenklinik der Universität Erlangen
Erlangen, Germany
Kliniken Essen-Mitte, Klinik für Senologie/ Interdisziplinäres Brustzentrum
Essen, Germany
Universitätsklinikum Essen, Frauenklinik
Essen, Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, Germany
Frankfurt University Department of Gynecology and Obstetrics
Frankfurt, Germany
AGAPLESION Markus Krankenhaus
Frankfurt am Main, Germany
Centrum for Haematology and Oncology
Frankurt Am Main, Germany
Universitätsklinik Freiburg, Klinik für Frauenheilkunde
Freiburg im Breisgau, Germany
Evangelische Kliniken Gelsenkirchen
Gelsenkirchen, Germany
MVZ II der Niels-Stensen-Kliniken
Georgsmarienhütte, Germany
SRH Waldklinikum Gera, Brustzentrum Ostthüringen
Gera, Germany
MVZ Onkologische Kooperation Harz
Goslar, Germany
Krankenhaus St. Elisabeth und St. Barbara Halle/Saale
Halle, Germany
University Medical Center
Hamburg, Germany
Mammazentrum HH am Krankenhaus Jerusalem
Hamburg, Germany
Albertinen Krankenhaus
Hamburg, Germany
Gynäkologisch-Ontologische Praxis Hannover
Hanover, Germany
DIAKOVERE Henriettenstift Frauenklinik
Hanover, Germany
Gemeinschaftspraxis Frauenärzte am Bahnhofsplatz
Hildesheim, Germany
Department of Gyencology and Obstetrics, Saarland University Hospital
Homburg, Germany
ViDia Christliche Kliniken Karlsruhe
Karlsruhe, Germany
Elisabethkrankenhaus Kassel, Brustzentrum
Kassel, Germany
Klinikum Kassel
Kassel, Germany
University Hospital Schleswig-Holstein
Kiel, Germany
Institut für Versorgungsforschung in der Onkologie
Koblenz, Germany
St. Vincenz KH Limburg
Limburg, Germany
UKSH Campus Lübeck
Lübeck, Germany
Universitäts-Frauenklinik
Magdeburg, Germany
Department of Obstetrics and Gynecology
Mainz, Germany
Medzinische Fakultät Mannheim, Universität Heidelberg
Mannheim, Germany
Klinikum Memmingen
Memmingen, Germany
Johannes Wesling Klinikum Minden, Hämatologie-Onkologie/Brustzentrum
Minden, Germany
Brustzentrum Niederrhein
Mönchengladbach, Germany
Gynaekologie Arabella
Munich, Germany
Rotkreuzklinikum München, Frauenklinik
München, Germany
Medizinisches Versorgungszentrum für Hämatologie und Onkologie München MVZ GmbH
München, Germany
LMU Klinikum/ Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
München, Germany
Dept. OB/GYN Johanna Etienne Krankenhaus
Neuss, Germany
Ortenau Klinikum Offenburg-Kehl
Offenburg, Germany
Klinikum Oldenburg AöR
Oldenburg, Germany
Frauenklinik St. Louise - St. Vincenz- Krankenhaus GmbH
Paderborn, Germany
Klinikum Ernst von Bergmann
Potsdam, Germany
Studienzentrum Onkologie Ravensburg
Ravensburg, Germany
Oncologianova GmbH
Recklinghausen, Germany
RoMed Klinikum Rosenheim
Rosenheim, Germany
Univ-Hospital, Dept Ob/Gyn
Rostock, Germany
CaritasKlinikum St. Theresia
Saarbrücken, Germany
Onkologische Schwerpunktpraxis Speyer
Speyer, Germany
G.SUND Gynäkologie Kompetenzzentrum
Stralsund, Germany
KKH Torgau
Torgau, Germany
Klinikum Mutterhaus
Trier, Germany
Praxisnetzwerk Hämatologie/Internistische Onkologie
Troisdorf, Germany
Frauenklinik
Tübingen, Germany
Universitätsfrauenklinik Ulm
Ulm, Germany
Schwarzwald - Baar Klinikum Frauenklinik
Villingen-Schwenningen, Germany
Harzklinikum Dorothea Christiane Erxleben
Wernigerode, Germany
St. Anna Hospital Brustzentrum
Witten, Germany
Klinikum Worms gGmbH
Worms, Germany
Aretaieio Hospital
Athens, Attica, Greece
General Hospital of Athens Alexandra Clinic
Athens, Attica, Greece
University General Hospital of Heraklion
Heraklion, Crete, Greece
University General Hospital of Patras
Pátrai, West Greece, Greece
General Hospital of Patras Agios Andreas
Pátrai, Greece
Pamela Youde Nethersole Eastern Hospital PYNEH
Hong Kong, Hong Kong
The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH)
Hong Kong, Hong Kong
The University of Hong Kong (HKU) - Queen Mary Hospital (QMH)
Pok Fu Lam, Hong Kong
Saint Vincents University Hospital
Dublin, IE-D, Ireland
St. James Hospital
Dublin, Leinster, Ireland
University College Cork
Cork, Ireland
Mater Misericordiae University Hospital
Dublin, Ireland
University Hospital Limerick
Limerick, Ireland
Soroka MC
Beersheba, Southern District, Israel
Sheba Medical Center
Ramat Gan, Tel Aviv, Israel
Hadassah Medical Center
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, Israel
Azienda Ospedaliera Garibaldi-Nesima
Catania, CT, Italy
Istituto Europeo di Oncologia
Milan, MI, Italy
Clinica Oncologica, Ospedali Riuniti Umberto 1
Ancona, Italy
Centro di Riferimento Oncologico di Aviano - SOC Oncologia Medica e Prevenzione Oncologica
Aviano, Italy
Istituto Oncologico di Bari
Bari, Italy
Azienda ULSS n. 1 Dolomiti
Belluno, Italy
Policlinico S.Orsola-Malpighi SSD Oncologia Medica Addarii
Bologna, Italy
SSD Oncologia Medica
Bologna, Italy
Presidio Ospedaliero di Summa - Antonio Perrino
Brindisi, Italy
Istituto di Candiolo - IRCCS
Candiolo, Italy
Ospedale Poli SAN MARTINO
Genova, Italy
Area Vasta Sud Est Sede Operativa Grosseto
Grosseto, Italy
Azienda Usl Toscana sud est
Grosseto, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
University Hospital of Modena
Modena, Italy
INT Fondazione Pascale
Naples, Italy
Istituto Oncologico Veneto IRCCS
Padova, Italy
ICS Maugeri IRCCS
Pavia, Italy
Azienda Ospedaliera di Perugia
Perugia, Italy
A.O.U. Citta della Salute e della Scienza di Torino
Torino, Italy
Hyogo Cancer Center
Akashi, Japan
National Cancer Center (NCC) - Tsukiji Campus - National Cancer Center Hospital (NCCH)
Chūōku, Japan
National Hospital Organization - National Kyushu Cancer Center
Fukuoka, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Japan
Tokai University Hospital - Isehara Campus
Isehara, Japan
Sagara Hospital
Kagoshima, Japan
National Cancer Center Hospital East (NCCHE) - Kashiwa Campus
Kashiwa, Japan
Japanese Foundation for Cancer Research (JFCR) - The Cancer Institute Hospital - Breast Oncology Center
Kōtoku, Japan
Kyoto University Hospital
Kyoto, Japan
National Hospital Organization (NHO) - Shikoku Cancer Center
Matsuyama, Japan
Aichi Cancer Center Hospital
Nagoya, Japan
Niigata Cancer Center Hospital
Niigata, Japan
Hyogo Medical University Hospital
Nishinomiya, Japan
Okayama University Hospital
Okayama, Japan
National Hospital Organization - Osaka National Hospital (ONH)
Osaka, Japan
Osaka International Cancer Institute (OICI)
Osaka, Japan
Saitama Cancer Center
Saitama, Japan
Kindai University (Kinki University) - Faculty of Medicine (Kinki University School of Medicine (KUSM)) - Kindai University Hospital (Kinki University Hospital) - Cancer Center
Sakai, Japan
National Hospital Organization - Hokkaido Cancer Center
Sapporo, Japan
Tohoku University Hospital (TUH) - Clinical Research, Innovation and Education Center (CRIETO)
Sendai, Japan
Showa Medical University Hospital - Breast Center
Shinagawa-Ku, Japan
Tokyo Medical University Hospital
Shinjuku-Ku, Japan
Shizuoka Cancer Center (SCC)
Shizuoka, Japan
Kanagawa Cancer Center Hospital - Kanagawa Cancer Center (Kanagawa Cancer Centre Research Institute)
Yokohama, Japan
CIMAB S.A. de C.V
Torreón, Coahuila, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Consultorio del Dr. Joaqun Gabriel Reinoso Toledo
Monterrey, Nuevo León, Mexico
Amsterdam UMC - VU Medisch Centrum
Amsterdam, North Holland, Netherlands
Amphia Hospital Breda
Breda, Netherlands
Erasmus MC - Daniel den Hoed Oncologisch Centrum
Rotterdam, Netherlands
Hospital Nacional Arzobispo Loayza
Lima, Peru
Clinica Ricardo Palma
Lima, Peru
Instituto Nacional de Enfermedades Neoplasicas INEN
Lima, Peru
Centro de Investigación Clinica Trujillo EIRL
Trujillo, Peru
Centrum Medyczne HCP Sp. z o.o.
Poznan, Greater Poland Voivodeship, Poland
SP Zoz Opolskie Centrum Onkologii IM
Opole, Opole Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Poland
MSCM Cancer Center and Institute of Oncology Department of Breast Cancer and Reconstructive Surgery
Warsaw, Poland
Hospital da Senhora da Oliveira, Guimarães EPE
Guimarães, Portugal
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
Lisbon, Portugal
Fundação Champalimaud
Lisbon, Portugal
Centro Hospitalar de Lisboa Ocidental, EPE
Lisbon, Portugal
Hospital da Luz
Lisbon, Portugal
Hospital CUF Descobertas
Lisbon, Portugal
Hospital Beatriz Ângelo
Loures, Portugal
Unidade Local de Saúde de Matosinhos, EPE
Matosinhos Municipality, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
Vila Nova de Gaia, Portugal
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, Cluj, Romania
Onco Clinic Consult SA
Craiova, Dolj, Romania
Centrul de Oncologie Sfantu Nectarie
Craiova, Dolj, Romania
Institutul Oncologic Bucuresti IOB
Bucharest, Romania
SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, Russia
State Budgetary Healthcare Institution Oncological Dispensary No. 2 of the Ministry of Health of Krasnodar Region
Sochi, Russia
National University Cancer Institute
Singapore, Singapore
National Cancer Center Singapore
Singapore, Singapore
Kyungpook National University Hospital
Daegu, South Korea
National Cancer Center
Gyeonggi-do, South Korea
CHA Bundang Medical Center CHA University
Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Samsung Medical Center
Irwon-dong, South Korea
Korea University Anam Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Asan Medical Center
Songpa-gu, South Korea
Soon Chun Hyang Central Medical Center (SCHMC)
Yongsan, South Korea
Hospital Universitario de Basurto
Bilbao, Bizkaia, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Universitario Sant Joan Reus
Reus, Tarragona, Spain
Complejo Hospitalario Universitario A Coruña (CHUA)
A Coruña, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Spain
Hospital General Universitario de Alicante
Alicante, Spain
Hospital de San Juan de Alicante
Alicante, Spain
Hospital Universitario de Badajoz
Badajoz, Spain
Hospital del Mar
Barcelona, Spain
IOB Institute Of Oncology-Hospital Quironsalud Barcelona
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitari Mútua Terrassa
Barcelona, Spain
ALTHAIA, Xarxa Assistencial Universitària de Manresa F.P.
Barcelona, Spain
Hospital de Mataró
Barcelona, Spain
ICO Hospitalet
Barcelona, Spain
ICO Badalona
Barcelona, Spain
Consorcio Hospitalario Provincial de Castelló
Castellon, Spain
Hospital Universitario San Pedro de Alcantara
Cáceres, Spain
ICO Girona
Girona, Spain
Hospital Universitario Clínico San Cecilio
Granada, Spain
Complejo Hospitalario de Jaen
Jaén, Spain
Complejo Asistencial Universitario de León
León, Spain
Hospital Arnau de Vilanova de Lleida
Lleida, Spain
Clinica Universidad De Navarra, Madrid
Madrid, Spain
Hospital MD Anderson Cancer Center Madrid
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
HM Sanchinarro (CIOCC)
Madrid, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Madrid, Spain
Hospital Universitario HM Puerta del Sur
Madrid, Spain
Hospital Universitario de Fuenlabrada
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Rey Juan Carlos
Móstoles, Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain
Complejo Hospitalario de Navarra
Navarro, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Spain
Hospital Son Llatzer
Palma de Mallorca, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Spain
Hospital General de Catalunya
Sant Cugat del Vallès, Spain
Complejo Hospitalario Clínico Universitario de Santiago de Compostela (CHUS)
Santiago de Compostela, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Quirón Salud Sagrado Corazón
Seville, Spain
Hospital Universtiario Virgen del Rocio
Seville, Spain
Fundación Instituto Valenciano de Oncologia (IVO)
Valencia, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Hospital Arnau de Vilanova de Valencia
Valencia, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
E-Da Cancer Hospital
Kaohsiung City, Yanchao District, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Beitou, Taiwan
Changhua Christian Hospital (CCH)
Chang-hua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Chi Mei Medical Center CMMC - Yongkang Branch
Tainan, Taiwan
National Taiwan University Hospital NTUH
Taipei, Taiwan
MacKay Memorial Hospital
Taipei, Taiwan
Taipei Veterans General Hospital TPVGH
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital CGMH
Taipei, Taiwan
Hacettepe University Cancer Institute
Ankara, İç Anadolu, Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, Turkey (Türkiye)
Istanbul Medeniyet University Medical Faculty
Istanbul, Turkey (Türkiye)
Medical Park - Izmir Hastanesi
Izmir, Turkey (Türkiye)
Peterborough City Hospital
Peterborough, Cambridgeshire, United Kingdom
Kent Oncology Centre Maidstone Hospital
Maidstone, Kent, United Kingdom
The Christie Hospital
Manchester, Lancashire, United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, Merseyside, United Kingdom
Nottingham University Hospitals
Nottingham, Nottinghamshire, United Kingdom
Royal United Hospital Bath NHS Trust - Royal United Hospital RUH
Bath, Somerset, United Kingdom
Somerset NHS Foundation Trust
Taunton, Somerset, United Kingdom
St. James University Hospital
Leeds, West Yorkshire, United Kingdom
Univeristy Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom
Colchester Hospital, East Suffolk & North Essex NHS Foundation Trust
Colchester, United Kingdom
Royal Devon Exeter NHS Foundation Trust
Exeter, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Guys and St Thomas NHS Foundation Trust
London, United Kingdom
Charing Cross Hospital
London, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Blackpool Victoria Hospital
Peterborough, United Kingdom
Trial Design & Scientific Setup
Allocation
randomized
Intervention Model
parallel
Primary Purpose
treatment
Masking
none
Sponsoring Teams & Contacts
Lead Sponsoring Institution
Daiichi Sankyo
Collaborators: AstraZeneca, NSABP Foundation Inc, GBG Forschungs GmbH, Spanish Breast Cancer Research Group
Clinical Trial Application Copilot

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Scientific Literature & 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 ↗
  • 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 ↗
View Official Medical/Scientific 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)