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)
HER2-Positive Primary Breast Cancer, Residual Invasive Breast Cancer
About this trial
This is an interventional treatment trial for HER2-Positive Primary Breast Cancer focused on measuring HER2-Positive Primary Breast Cancer, Residual Invasive Breast Cancer, Trastuzumab Deruxtecan, Trastuzumab Emtansine
Eligibility Criteria
Key Inclusion Criteria:
- 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 chemotherapy, including taxane and HER2-directed treatment prior to surgery
- Systemic therapy must consist of at least 6 cycles of chemotherapy 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. 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 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.
Key Exclusion Criteria:
- 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)
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
- 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 with pulmonary involvement (eg, Rheumatoid arthritis, Sjogren's, sarcoidosis, etc.), or prior lobectomy or pneumonectomy
- 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
Sites / Locations
- The Oncology Institute of Hope & InnovationRecruiting
- Kaiser PermanenteRecruiting
- Kaiser PermanenteRecruiting
- Kaiser PermanenteRecruiting
- Kaiser PermanenteRecruiting
- Orange Coast Blood and Cancer CareRecruiting
- Orange Coast Memorial Med Center
- Kaiser PermanenteRecruiting
- Kaiser PermanenteRecruiting
- Long Beach Memorial TCIRecruiting
- Kaiser PermanenteRecruiting
- Kaiser PermanenteRecruiting
- Kaiser PermanenteRecruiting
- Kaiser PermanenteRecruiting
- Kaiser PermanenteRecruiting
- Kaiser PermanenteRecruiting
- Kaiser PermanenteRecruiting
- Kaiser PermanenteRecruiting
- SCRI FCS North- AltamonteRecruiting
- SCRI FCS South- BonitaRecruiting
- SCRI FCS North- Brandon Cancer CenterRecruiting
- SCRI FCS South- North Fort MyersRecruiting
- SCRI FCS North- Mease/ClearwaterRecruiting
- SCRI FCS SouthRecruiting
- SCRI FCS South- ColonialRecruiting
- SCRI FCS South- GladiolusRecruiting
- SCRI FCS North- Gainesville Cancer CenterRecruiting
- Baptist MD Anderson Cancer CenterRecruiting
- SCRI FCS North- Villages EastRecruiting
- SCRI FCS South- Lakewood RanchRecruiting
- SCRI FCS North- Largo/HighlandRecruiting
- SCRI FCS North- LecantoRecruiting
- SCRI FCS South- Naples WestRecruiting
- SCRI FCS South- Naples/GoodletteRecruiting
- SCRI FCS North- New Port RicheyRecruiting
- SCRI FCS North- OcalaRecruiting
- Orlando HealthRecruiting
- SCRI FCS North- Orange CityRecruiting
- Orlando HealthRecruiting
- SCRI FCS North- Orlando DowntownRecruiting
- SCRI FCS South- Port CharlotteRecruiting
- SCRI FCS North- St. Anthony's/St. PetersburgRecruiting
- SCRI FCS NorthRecruiting
- SCRI FCS South- Sarasota-CattlemanRecruiting
- SCRI FCS South-Sarasota-DowntownRecruiting
- SCRI FCS North- Spring HillRecruiting
- SCRI FCS North- Tampa Cancer CenterRecruiting
- SCRI FCS North- TavaresRecruiting
- SCRI FCS South- Venice HealthparkRecruiting
- Cleveland Clinic-WestonRecruiting
- SCRI FCS North- Winter ParkRecruiting
- Elmhurst Memorial Hospital- Nancy W. Knowles Cancer CenterRecruiting
- Edward Cancer CenterRecruiting
- Illinois CancerCare
- Edward Cancer Center PlainfieldRecruiting
- University of Kentucky, Markey Cancer Center, Clinical Research Organization
- Baptist Health LouisvilleRecruiting
- LSU Health Baton Rouge North ClinicRecruiting
- Our Lady of the Lake Physician Group-Medical OncologyRecruiting
- Our Lady of the Lake Physicians Group-Medical Oncology-Woman's Pavilion
- Mary Bird Perkins Cancer Center
- Ochsner Hematology Oncology North Shore - Covington (West Region)
- Ochsner Clinic FoundationRecruiting
- Mercy Medical Center
- MedStar Franklin Square Medical Center-Harry and Jeanette Weinberg Cancer InstituteRecruiting
- MedStar Franklin Square Cancer Center at Loch Raven CampusRecruiting
- Richard A. Henson Cancer Institute Ocean Pines
- Frederick Health-James M Stockman Cancer CenterRecruiting
- Peninsula Regional Medical Center
- Maryland Oncology HematologyRecruiting
- Holy Cross HospitalRecruiting
- Montefiore Medical CenterRecruiting
- Waverly Hematology Oncology
- Levine Cancer Inst Pineville
- Levince Cancer Institute
- Carolinas Medical Center Northeast
- UNC REX Cancer Center
- UNC REX Cancer Center of Wakefield
- UNC Cancer Care at NashRecruiting
- Wake Forest Baptist Medical CenterRecruiting
- Cleveland Clinic - HillcrestRecruiting
- Cleveland Clinic-FairviewRecruiting
- Cleveland ClinicRecruiting
- Cleveland Clinic South PointeRecruiting
- Kaiser Permanente Northwest--Oncology
- UPMC Upper St. ClairRecruiting
- UPMC Passavant Cranberry/NorthRecruiting
- UPMC ErieRecruiting
- AHN Cancer Inst at St VincentRecruiting
- UPMC Arnold Palmer-Mt ViewRecruiting
- UPMC Pinnacle-Ortenzio Cancer CenterRecruiting
- UMPC Pinnacle PharmacyRecruiting
- AHN Cancer Insititute at JeffersonRecruiting
- AHN Cancer Institute at ForbesRecruiting
- UPMC MonroevilleRecruiting
- UPMC Arnold Palmer-Mt PleasantRecruiting
- UPMC Arnold Palmer-NorwinRecruiting
- Allegheny General HospitalRecruiting
- MageeRecruiting
- UPMC St. MargaretRecruiting
- AHN Cancer Inst at West PennRecruiting
- UPMC Hillman Cancer CenterRecruiting
- UPMC Passavant HOARecruiting
- UPMC Passavant OHARecruiting
- UPMC UniontownRecruiting
- UPMC WashingtonRecruiting
- Reading Hospital, McGlinn Cancer InstituteRecruiting
- AHN Cancer Institute at WexfordRecruiting
- UPMC Pinnacle-Memorial Cancer CenterRecruiting
- Women & Infants Hospital of RI
- SCRI TO Nashville- Franklin Tennessee Oncology, PLLCRecruiting
- SCRI TO Nashville- Gallatin Tennessee Oncology, PLLCRecruiting
- SCRI TO Nashville- Hendersonville Tennessee Oncology, PLLCRecruiting
- SCRI TO Nashville- Summit Tennessee Oncology, PLLCRecruiting
- Regional Cancer Center at Indian Path Community HospitalRecruiting
- SCRI TO Nashville- Lebanon Tennessee Oncology, PLLCRecruiting
- SCRI TO Nashville- St. Thomas Midtown Tennessee Oncology, PLLCRecruiting
- Tennessee Oncology Nashville / Sarah CannonRecruiting
- SCRI TO Nashville- St. Thomas West Tennessee Oncology, PLLCRecruiting
- SCRI TO Nashville- Skyline Tennessee Oncology, PLLCRecruiting
- SCRI TO Nashville- Southern Hills Tennessee Oncology, PLLCRecruiting
- SCRI TO Nashville- Smyrna Tennessee Oncology, PLLCRecruiting
- Houston Methodist BaytownRecruiting
- Houston MethodistRecruiting
- Houston Methodist WillowbrookRecruiting
- Houston Methodist WestRecruiting
- Houston Methodist Clear LakeRecruiting
- Houston Methodist SugarlandRecruiting
- Houston Methodist WoodlandsRecruiting
- Wellmont Medical Associates Oncology & HematologyRecruiting
- University of VirginiaRecruiting
- Centra Lynchburg Hematology Oncology
- Virginia Commonwealth University Massey Cancer CenterRecruiting
- MultiCare Cancer Center AurburnRecruiting
- MultiCare Regional Cancer Center - Gig HarborRecruiting
- MultiCare Cancer Center PuyallupRecruiting
- MultiCare Institute for Research & InnovationRecruiting
- MultiCare Institute for Research & Innovation - East Sinto
- MultiCare Institute for Research & InnovationRecruiting
- MultiCare Cancer Center TacomaRecruiting
- West Virginia UniversityRecruiting
- Centro Oncologico Riojano IntegralRecruiting
- Sanatorio Británico de RosarioRecruiting
- Instituto de Oncología de RosarioRecruiting
- COIBARecruiting
- Hospital Aleman
- Instituto Alexander FlemingRecruiting
- CER San JuanRecruiting
- Royal Adelaide HospitalRecruiting
- Chris O Brien LifehouseRecruiting
- Monash HealthRecruiting
- Austin Hospital- Olivia Newto-John Cancer and Wellness CentreRecruiting
- Peter MacCallum Cancer CentreRecruiting
- Breast Cancer Research Centre - WARecruiting
- Genesis Care Northern CancerRecruiting
- St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC)Recruiting
- Southern Medical Day Care CentreRecruiting
- Antwerp University HospitalRecruiting
- UZ GentRecruiting
- Algemeen Ziekenhuis AZ Klina - BorstkliniekRecruiting
- Institut Jules Bordet Brussels BelgiumRecruiting
- Cliniques Universitaires Saint-LucRecruiting
- UZ Leuven - Campus GasthuisbergRecruiting
- CHU LiegeRecruiting
- GZA Hospitals Campus Sint- Augustinus
- Hospital Sirio-Libanes HSL - Centro de Oncologia - BrasiliaRecruiting
- Hospital Erasto GaertnerRecruiting
- Fundação Universidade de Caxias do Sul Instituto de Pesquisas em Saúde IPS-UCSRecruiting
- Hospital Sao Lucas PUCRSRecruiting
- Fundacao Pio XII-Hospital de Cancer de BarretosRecruiting
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e OncologiaRecruiting
- Hospital de Base de Sao Jose do Rio PretoRecruiting
- INCA - Instituto Nacional do Cancer / Hospital do Cancer HCIIIRecruiting
- Instituto do Cancer do Estado de Sao Paulo (ICESP)Recruiting
- Tom Baker Cancer CentreRecruiting
- The Ottawa Hospital Cancer Centre
- CIUSSSS de l'Est-de-l'Ile-de-Montréal - Installation Hôpital Maisonneuve-RosemontRecruiting
- CHUMRecruiting
- Jewish General Hospital Segal Cancer CentreRecruiting
- McGill University Health Centre - Cedars Cancer CentreRecruiting
- CHU de Quebec - Hopital du Saint-SacrementRecruiting
- Hospital Clinico Universidad de ChileRecruiting
- Fundacion Arturo Lopez PerezRecruiting
- SIM CRC
- Peking University Cancer HospitalRecruiting
- Peking University Third HospitalRecruiting
- Jilin University JLU - First Affiliated HospitalRecruiting
- Sichuan University - West China HospitalRecruiting
- Chongqing Medical University - The First Affiliated HospitalRecruiting
- Union Hospital of Fujian Medical UniversityRecruiting
- Sun Yat-sen Memorial HospitalRecruiting
- Guangdong Academy of Medical ScienceRecruiting
- Zhejiang Cancer HospitalRecruiting
- Second Affiliated Hospital of Zhejiang UniversityRecruiting
- Harbin Medical University Cancer HospitalRecruiting
- Shandong Cancer HospitalRecruiting
- Nanchang University - The First Affiliated HospitalRecruiting
- Nanjing Medical University NMU - Jiangsu Province HospitalRecruiting
- Fudan University Cancer HospitalRecruiting
- Liaoning Cancer Hospital InstituteRecruiting
- The 4th Hospital of Heibei Medical UniversityRecruiting
- The First Affiliated Hospital of Xiamen UniversityRecruiting
- University Hospital BrnoRecruiting
- Fakultni nemocnice Kralovske VinohradyRecruiting
- Aalborg University HospitalRecruiting
- Aarhus University Hospital
- RigshospitaletRecruiting
- Odense University HospitalRecruiting
- Soenderborg sygehusRecruiting
- Clinique Tivoli Ducos - Centre dOncologie et de Radiotherapie a BordeauxRecruiting
- Institut Claudius RegaudRecruiting
- Institut De Cancerologie De La LoireRecruiting
- CHR Metz-ThionvilleRecruiting
- Institut BergonieRecruiting
- Centre Georges François LeclercRecruiting
- CHD VendeeRecruiting
- Centre Hosp Univ de Grenoble CHUGRecruiting
- Centre Oscar LambretRecruiting
- Centre Leon BerardRecruiting
- Institut Paoli-CalmettesRecruiting
- Centre de Cancérologie du Grand MontpellierRecruiting
- The Sel of Centre dOncologie de GentillyRecruiting
- Centre Antoine LacassagneRecruiting
- Hospital St LouisRecruiting
- Hopital Georges PompidouRecruiting
- IUC AP-HP. Sorbonne Université, Hôpital TenonRecruiting
- CHU de PoitiersRecruiting
- Centre Eugene Marquis
- Institut de cancerologie de l'ouestRecruiting
- Strasbourg Europe Cancer InstituteRecruiting
- Gemeinschaftspraxis Dres. Halder / BangerterRecruiting
- Cahrité Campus Mitte
- Praxis Dr. med. J. SchillingRecruiting
- MediOnko-Institut GbR, Praxisklinik KrebsheilkundeRecruiting
- DRK Kliniken Berlin Köpenick
- Helios Klinikum Berlin-BuchRecruiting
- Onkologische SchwerpunktpraxisRecruiting
- Onkologische SchwerpunktpraxisRecruiting
- Studien GbR BraunschweigRecruiting
- Klinikum Bremen MitteRecruiting
- Hämato-Onkologische Praxis im Medicum
- Frauenklinik DIAKO BremenRecruiting
- Klinikverbund Südwest Kliniken Böblingen Frauenklinik BöblingenRecruiting
- Klinikum Chemnitz gGmbH
- DONAUISAR KlinikumRecruiting
- Klinikum Dortmund gGmbHRecruiting
- St.-Johannes-Hospital Dortmund, Dept. of Obstetrics/GynecologyRecruiting
- Onkologische Schwerpunktpraxis
- University Hospital DresdenRecruiting
- Onkozentrum DresdenRecruiting
- Universitätsklinikum Düsseldorf, Klinik für Frauenheilkunde & GeburtshilfeRecruiting
- Frauenklinik der Universität ErlangenRecruiting
- Kliniken Essen-Mitte, Klinik für Senologie/ Interdisziplinäres BrustzentrumRecruiting
- Universitätsklinikum Essen, FrauenklinikRecruiting
- Klinikum Esslingen GmbHRecruiting
- AGAPLESION Markus Krankenhaus
- Frankfurt University Department of Gynecology and ObstetricsRecruiting
- Centrum for Haematology and Oncology
- Universitätsklinik Freiburg, Klinik für FrauenheilkundeRecruiting
- Gynäkologisch-Onkologische SP-Praxis
- Evangelische Kliniken GelsenkirchenRecruiting
- MVZ II der Niels-Stensen-KlinikenRecruiting
- SRH Waldklinikum Gera, Brustzentrum Ostthüringen
- MVZ Onkologische Kooperation Harz
- Krankenhaus St. Elisabeth und St. Barbara Halle/SaaleRecruiting
- University Medical Center
- Mammazentrum HH am Krankenhaus JerusalemRecruiting
- Albertinen KrankenhausRecruiting
- Gynäkologisch-Ontologische Praxis HannoverRecruiting
- DIAKOVERE Henriettenstift Frauenklinik
- Gemeinschaftspraxis Frauenärzte am BahnhofsplatzRecruiting
- Department of Gyencology and Obstetrics, Saarland University HospitalRecruiting
- ViDia Christliche Kliniken KarlsruheRecruiting
- Elisabethkrankenhaus Kassel, BrustzentrumRecruiting
- Klinikum KasselRecruiting
- University Hospital Schleswig-Holstein
- Institut für Versorgungsforschung in der OnkologieRecruiting
- Unifrauenklinik Köln - Studienzentrum Gynäkologie
- St. Elisabeth HospitalRecruiting
- Kliniken der Stadt Köln / Brustzentrum Holweide
- St. Elisabeth Krankenhaus
- St. Vincenz KH Limburg
- UKSH Campus Lübeck
- Universitäts-FrauenklinikRecruiting
- Department of Obstetrics and GynecologyRecruiting
- Medzinische Fakultät Mannheim, Universität Heidelberg
- Klinikum Memmingen
- Johannes Wesling Klinikum Minden, Hämatologie-Onkologie/BrustzentrumRecruiting
- Rotkreuzklinikum München, FrauenklinikRecruiting
- Gynaekologie Arabella
- Brustzentrum NiederrheinRecruiting
- Medizinisches Versorgungszentrum für Hämatologie und Onkologie München MVZ GmbHRecruiting
- LMU Klinikum/ Klinik und Poliklinik für Frauenheilkunde und GeburtshilfeRecruiting
- Dept. OB/GYN Johanna Etienne Krankenhaus
- Ortenau Klinikum Offenburg-Kehl
- Klinikum Oldenburg AöRRecruiting
- Frauenklinik St. Louise - St. Vincenz- Krankenhaus GmbHRecruiting
- Klinikum Ernst von BergmannRecruiting
- Studienzentrum Onkologie RavensburgRecruiting
- Oncologianova GmbHRecruiting
- RoMed Klinikum RosenheimRecruiting
- Univ-Hospital, Dept Ob/GynRecruiting
- CaritasKlinikum St. TheresiaRecruiting
- Onkologische Schwerpunktpraxis Speyer
- G.SUND Gynäkologie KompetenzzentrumRecruiting
- KKH TorgauRecruiting
- Klinikum Mutterhaus
- Praxisnetzwerk Hämatologie/Internistische OnkologieRecruiting
- Frauenklinik
- Universitätsfrauenklinik UlmRecruiting
- Schwarzwald - Baar Klinikum Frauenklinik
- Harzklinikum Dorothea Christiane Erxleben
- St. Anna Hospital BrustzentrumRecruiting
- Klinikum Worms gGmbHRecruiting
- General Hospital of Athens Alexandra ClinicRecruiting
- University General Hospital of HeraklionRecruiting
- University General Hospital of PatrasRecruiting
- General Hospital of Patras Agios AndreasRecruiting
- Pamela Youde Nethersole Eastern Hospital PYNEHRecruiting
- The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH)Recruiting
- The University of Hong Kong (HKU) - Queen Mary Hospital (QMH)Recruiting
- Saint Vincents University HospitalRecruiting
- St. James HospitalRecruiting
- University College CorkRecruiting
- Mater Misericordiae University HospitalRecruiting
- University Hospital LimerickRecruiting
- Soroka MCRecruiting
- Sheba Medical CenterRecruiting
- Hadassah Medical CenterRecruiting
- Shaare Zedek Medical CenterRecruiting
- Rabin Medical CenterRecruiting
- Azienda Ospedaliera Garibaldi-NesimaRecruiting
- Istituto Europeo di OncologiaRecruiting
- Clinica Oncologica, Ospedali Riuniti Umberto 1Recruiting
- Centro di Riferimento Oncologico di Aviano - SOC Oncologia Medica e Prevenzione OncologicaRecruiting
- Istituto Oncologico di Bari
- Azienda ULSS n. 1 DolomitiRecruiting
- Policlinico S.Orsola-Malpighi SSD Oncologia Medica Addarii
- SSD Oncologia MedicaRecruiting
- Presidio Ospedaliero di Summa - Antonio PerrinoRecruiting
- Istitutoperla Ricercaela Curadel Cancro IRCC
- Istituto Naz per la Ricerca sul Cancro (IST) Genov
- Area Vasta Sud Est Sede Operativa Grosseto
- Azienda Usl Toscana sud estRecruiting
- IRCCS Ospedale San RaffaeleRecruiting
- University Hospital of ModenaRecruiting
- INT Fondazione Pascale
- Istituto Oncologico Veneto IRCCS
- ICS Maugeri IRCCSRecruiting
- Azienda Ospedaliera di PerugiaRecruiting
- A.O.U. Citta della Salute e della Scienza di TorinoRecruiting
- Hyogo Cancer CenterRecruiting
- National Cancer Center (NCC) - Tsukiji Campus - National Cancer Center Hospital (NCCH)Recruiting
- National Hospital Organization - National Kyushu Cancer CenterRecruiting
- Hiroshima City Hiroshima Citizens HospitalRecruiting
- Tokai University Hospital - Isehara CampusRecruiting
- Sagara HospitalRecruiting
- National Cancer Center Hospital East (NCCHE) - Kashiwa CampusRecruiting
- Japanese Foundation for Cancer Research (JFCR) - The Cancer Institute Hospital - Breast Oncology CenterRecruiting
- Kyoto University HospitalRecruiting
- National Hospital Organization (NHO) - Shikoku Cancer CenterRecruiting
- Aichi Cancer Center HospitalRecruiting
- Niigata Cancer Center HospitalRecruiting
- Hyogo College of Medicine HospitalRecruiting
- Okayama University HospitalRecruiting
- National Hospital Organization - Osaka National Hospital (ONH)Recruiting
- Osaka International Cancer Institute (OICI)Recruiting
- Saitama Cancer CenterRecruiting
- National Hospital Organization - Hokkaido Cancer CenterRecruiting
- Kindai University (Kinki University) - Faculty of Medicine (Kinki University School of Medicine (KUSM)) - Kindai University Hospital (Kinki University Hospital) - Cancer CenterRecruiting
- Tohoku University Hospital (TUH) - Clinical Research, Innovation and Education Center (CRIETO)Recruiting
- Showa University Hospital - Breast CenterRecruiting
- Tokyo Medical University HospitalRecruiting
- Shizuoka Cancer Center (SCC)Recruiting
- Kanagawa Cancer Center Hospital - Kanagawa Cancer Center (Kanagawa Cancer Centre Research Institute)Recruiting
- Kyungpook National University HospitalRecruiting
- National Cancer CenterRecruiting
- CHA Bundang Medical Center CHA UniversityRecruiting
- Seoul National University Bundang HospitalRecruiting
- Gachon University Gil Medical CenterRecruiting
- Samsung Medical CenterRecruiting
- Korea University Anam HospitalRecruiting
- Seoul National University HospitalRecruiting
- Severance HospitalRecruiting
- Asan Medical CenterRecruiting
- Soon Chun Hyang Central Medical Center (SCHMC)Recruiting
- Clinstile SA de CVRecruiting
- CIMAB S.A. de C.VRecruiting
- Hospital Civil de Guadalajara Fray Antonio AlcaldeRecruiting
- Consultorio del Dr. Joaqun Gabriel Reinoso Toledo
- Amsterdam UMC - VU Medisch CentrumRecruiting
- Amphia Hospital BredaRecruiting
- Erasmus MC - Daniel den Hoed Oncologisch CentrumRecruiting
- Hospital Nacional Arzobispo LoayzaRecruiting
- Clinica Ricardo PalmaRecruiting
- Instituto Nacional de Enfermedades Neoplasicas INENRecruiting
- Centro de Investigación Clinica Trujillo EIRLRecruiting
- SP Zoz Opolskie Centrum Onkologii IMRecruiting
- Uniwersyteckie Centrum KliniczneRecruiting
- Centrum Medyczne HCP Sp. z o.o.Recruiting
- MSCM Cancer Center and Institute of Oncology Department of Breast Cancer and Reconstructive SurgeryRecruiting
- Instytut Centrum Zdrowia Matki PolkiRecruiting
- Hospital da Senhora da Oliveira, Guimarães EPERecruiting
- Instituto Português de Oncologia de Lisboa Francisco Gentil, EPERecruiting
- Fundação ChampalimaudRecruiting
- Centro Hospitalar de Lisboa Ocidental, EPERecruiting
- Hospital da LuzRecruiting
- Hospital CUF DescobertasRecruiting
- Hospital Beatriz ÂngeloRecruiting
- Unidade Local de Saúde de Matosinhos, EPERecruiting
- Instituto Português de Oncologia do Porto Francisco Gentil, EPERecruiting
- Centro Hospitalar de Vila Nova de Gaia/Espinho, EPERecruiting
- Institutul Oncologic Prof. Dr. Ion ChiricutaRecruiting
- Onco Clinic Consult SARecruiting
- Centrul de Oncologie Sfantu NectarieRecruiting
- Institutul Oncologic Bucuresti IOBRecruiting
- State Budget Healthcare Institution of Stavropol Region
- SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary
- State Budgetary Healthcare Institution Oncological Dispensary No. 2 of the Ministry of Health of Krasnodar Region
- National University Cancer InstituteRecruiting
- National Cancer Center SingaporeRecruiting
- Hospital Universitario de BasurtoRecruiting
- Hospital Clínico Universitario Virgen de la ArrixacaRecruiting
- Vithas Xanit International Hospital
- Hospital Universitario Sant Joan ReusRecruiting
- Hospital Universitario Fundación AlcorcónRecruiting
- Hospital General Universitario de AlicanteRecruiting
- Hospital Universitario de Torrevieja
- Hospital de San Juan de AlicanteRecruiting
- Hospital Universitario de Badajoz
- Hospital del MarRecruiting
- IOB Institute Of Oncology-Hospital Quironsalud BarcelonaRecruiting
- Hospital Universitari Vall d'HebronRecruiting
- Hospital Clínic de BarcelonaRecruiting
- Hospital Universitari Mútua TerrassaRecruiting
- ALTHAIA, Xarxa Assistencial Universitària de Manresa F.P.Recruiting
- Hospital de MataróRecruiting
- ICO HospitaletRecruiting
- ICO BadalonaRecruiting
- Consorcio Hospitalario Provincial de Castelló
- Complejo Hospitalario Universitario A Coruña (CHUA)Recruiting
- Hospital Universitario San Pedro de AlcantaraRecruiting
- ICO GironaRecruiting
- Hospital Universitario Clínico San CecilioRecruiting
- Complejo Hospitalario de JaenRecruiting
- Complejo Asistencial Universitario de LeónRecruiting
- Hospital Arnau de Vilanova de LleidaRecruiting
- Clinica Universidad De Navarra, MadridRecruiting
- Hospital MD Anderson Cancer Center MadridRecruiting
- Hospital Universitario Ramón y CajalRecruiting
- Hospital Universitario Fundación Jiménez Díaz
- Hospital Universitario 12 de OctubreRecruiting
- Hospital Universitario La PazRecruiting
- HM Sanchinarro (CIOCC)Recruiting
- Hospital Universitario Puerta de Hierro de MajadahondaRecruiting
- Hospital Universitario HM Puerta del SurRecruiting
- Hospital Universitario de FuenlabradaRecruiting
- Hospital General Universitario Morales MeseguerRecruiting
- Hospital Universitario Virgen de la VictoriaRecruiting
- Hospital Universitario Rey Juan CarlosRecruiting
- Complejo Hospitalario de Navarra
- Hospital Universitari Son EspasesRecruiting
- Hospital Son LlatzerRecruiting
- Hospital Universitario de CanariasRecruiting
- Hospital General de CatalunyaRecruiting
- Complejo Hospitalario Clínico Universitario de Santiago de Compostela (CHUS)Recruiting
- Hospital Universitario Virgen MacarenaRecruiting
- Hospital Quirón Salud Sagrado CorazónRecruiting
- Hospital Universtiario Virgen del RocioRecruiting
- Fundación Instituto Valenciano de Oncologia (IVO)Recruiting
- Hospital Clínico Universitario de ValenciaRecruiting
- Hospital Arnau de Vilanova de ValenciaRecruiting
- Hospital Clínico Universitario Lozano BlesaRecruiting
- E-Da Cancer HospitalRecruiting
- Koo Foundation Sun Yat-Sen Cancer CenterRecruiting
- Changhua Christian Hospital (CCH)Recruiting
- Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
- China Medical University HospitalRecruiting
- Taichung Veterans General HospitalRecruiting
- National Cheng Kung University HospitalRecruiting
- Chi Mei Medical Center CMMC - Yongkang BranchRecruiting
- National Taiwan University Hospital NTUHRecruiting
- MacKay Memorial HospitalRecruiting
- Taipei Veterans General Hospital TPVGHRecruiting
- Tri-Service General HospitalRecruiting
- Chang Gung Memorial Hospital CGMHRecruiting
- Hacettepe University Cancer Institute
- Trakya University Medical Faculty
- Istanbul Medeniyet University Medical Faculty
- Medical Park - Izmir Hastanesi
- Peterborough City HospitalRecruiting
- Kent Oncology Centre Maidstone Hospital
- The Christie HospitalRecruiting
- Clatterbridge Cancer Centre
- Nottingham University HospitalsRecruiting
- Royal United Hospital Bath NHS Trust - Royal United Hospital RUHRecruiting
- Somerset NHS Foundation TrustRecruiting
- St. James University HospitalRecruiting
- Univeristy Hospitals Bristol NHS Foundation Trust
- Colchester Hospital, East Suffolk & North Essex NHS Foundation TrustRecruiting
- Royal Devon Exeter NHS Foundation Trust
- Beatson West of Scotland Cancer CentreRecruiting
- Guys and St Thomas NHS Foundation TrustRecruiting
- Charing Cross HospitalRecruiting
- Oxford University Hospitals NHS Foundation TrustRecruiting
- Blackpool Victoria Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Trastuzumab deruxtecan (T-DXd)
Trastuzumab ematansine (T-DM1)
Participants who will be randomized to receive trastuzumab deruxtecan (T-DXd) at a starting dose of 5.4 mg/kg.
Participants who will be randomized to receive trastuzumab ematansine (T-DM1) at a starting dose of 3.6 mg/kg.