HER2-Positive Primary Breast Cancer Clinical Trial
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)
| Verified date | December 2023 |
| Source | Daiichi Sankyo, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 1600 |
| Est. completion date | December 31, 2030 |
| Est. primary completion date | December 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 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. 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) 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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | COIBA | Buenos Aires | |
| Argentina | Hospital Aleman | Buenos Aires | |
| Argentina | Instituto Alexander Fleming | Caba | |
| Argentina | Centro Oncologico Riojano Integral | Capital | La Rioja |
| Argentina | Instituto de Oncología de Rosario | Rosario | Santa Fe |
| Argentina | Sanatorio Británico de Rosario | Rosario | Santa Fe |
| Argentina | CER San Juan | San Juan | |
| Australia | 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 | |
| Belgium | Algemeen Ziekenhuis AZ Klina - Borstkliniek | Brasschaat | |
| Belgium | Cliniques Universitaires Saint-Luc | Brussels | |
| Belgium | Institut Jules Bordet Brussels Belgium | Brussels | |
| Belgium | Antwerp University Hospital | Edegem | Antwerpen |
| Belgium | UZ Gent | Gent | O. Vl. |
| Belgium | UZ Leuven - Campus Gasthuisberg | Leuven | |
| Belgium | CHU Liege | Liège | |
| Belgium | GZA Hospitals Campus Sint- Augustinus | Wilrijk | |
| Brazil | Fundacao Pio XII-Hospital de Cancer de Barretos | Barretos | SP |
| Brazil | Hospital Sirio-Libanes HSL - Centro de Oncologia - Brasilia | Brasília | Federal District |
| Brazil | Fundação Universidade de Caxias do Sul Instituto de Pesquisas em Saúde IPS-UCS | Caxias Do Sul | Rio Grande Do Sul |
| Brazil | Hospital Erasto Gaertner | Curitiba | Parana |
| Brazil | Hospital Sao Lucas PUCRS | Porto Alegre | RS |
| Brazil | INCA - Instituto Nacional do Cancer / Hospital do Cancer HCIII | Rio De Janeiro | |
| Brazil | CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia | Santo André | SP |
| Brazil | Hospital de Base de Sao Jose do Rio Preto | São José Do Rio Preto | SP |
| Brazil | Instituto do Cancer do Estado de Sao Paulo (ICESP) | São Paulo | |
| Canada | Tom Baker Cancer Centre | Calgary | Alberta |
| Canada | CHUM | Montréal | Quebec |
| Canada | CIUSSSS de l'Est-de-l'Ile-de-Montréal - Installation Hôpital Maisonneuve-Rosemont | Montréal | Quebec |
| Canada | Jewish General Hospital Segal Cancer Centre | Montréal | Quebec |
| Canada | McGill University Health Centre - Cedars Cancer Centre | Montréal | Quebec |
| Canada | The Ottawa Hospital Cancer Centre | Ottawa | Ontario |
| Canada | CHU de Quebec - Hopital du Saint-Sacrement | Québec | Quebec |
| Chile | Fundacion Arturo Lopez Perez | Santiago | |
| Chile | Hospital Clinico Universidad de Chile | Santiago | RM |
| Chile | SIM CRC | Temuco | |
| China | 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 | Guangdong Academy of Medical Science | Guangzhou | |
| China | Sun Yat-sen Memorial Hospital | Guangzhou | |
| China | Second Affiliated Hospital of Zhejiang University | Hangzhou | |
| China | Zhejiang Cancer Hospital | 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 | |
| Czechia | University Hospital Brno | Brno | |
| Czechia | Fakultni nemocnice Kralovske Vinohrady | Prague | |
| Denmark | Aalborg University Hospital | Aalborg | |
| Denmark | Aarhus University Hospital | Aarhus | |
| Denmark | Rigshospitalet | Copenhagen | |
| Denmark | Odense University Hospital | Odense | |
| Denmark | Soenderborg sygehus | Syddanmark | |
| France | Clinique Tivoli Ducos - Centre dOncologie et de Radiotherapie a Bordeaux | Bordeaux | Gironde |
| 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 | CHR Metz-Thionville | Metz cedex 03 | Lorraine |
| France | Centre de Cancérologie du Grand Montpellier | Montpellier | |
| France | The Sel of Centre dOncologie de Gentilly | Nancy | |
| France | Centre Antoine Lacassagne | Nice | |
| France | Hopital Georges Pompidou | Paris | |
| France | Hospital St Louis | 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 | Institut De Cancerologie De La Loire | Saint-Priest-en-Jarez | Loire |
| France | Strasbourg Europe Cancer Institute | Strasbourg | |
| France | Institut Claudius Regaud | Toulouse | Haute Garonne |
| Germany | Gemeinschaftspraxis Dres. Halder / Bangerter | Augsburg | |
| Germany | Cahrité Campus Mitte | Berlin | |
| Germany | DRK Kliniken Berlin Köpenick | Berlin | |
| Germany | Helios Klinikum Berlin-Buch | Berlin | |
| Germany | MediOnko-Institut GbR, Praxisklinik Krebsheilkunde | Berlin | |
| Germany | Onkologische Schwerpunktpraxis | Berlin | |
| Germany | Praxis Dr. med. J. Schilling | Berlin | |
| Germany | Onkologische Schwerpunktpraxis | Bielefeld | |
| Germany | Klinikverbund Südwest Kliniken Böblingen Frauenklinik Böblingen | Böblingen | |
| Germany | Studien GbR Braunschweig | Braunschweig | |
| Germany | Frauenklinik DIAKO Bremen | Bremen | |
| Germany | Klinikum Bremen Mitte | Bremen | |
| Germany | Klinikum Chemnitz gGmbH | Chemnitz | |
| Germany | DONAUISAR Klinikum | Deggendorf | |
| Germany | Klinikum Dortmund gGmbH | Dortmund | |
| Germany | St.-Johannes-Hospital Dortmund, Dept. of Obstetrics/Gynecology | Dortmund | |
| Germany | Onkologische Schwerpunktpraxis | Dresden | |
| Germany | Onkozentrum Dresden | Dresden | |
| Germany | University Hospital 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 | |
| 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 | |
| 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/saale | |
| Germany | Albertinen Krankenhaus | Hamburg | |
| Germany | Mammazentrum HH am Krankenhaus Jerusalem | Hamburg | |
| Germany | University Medical Center | Hamburg | |
| Germany | DIAKOVERE Henriettenstift Frauenklinik | Hannover | |
| Germany | Gynäkologisch-Ontologische Praxis Hannover | Hannover | |
| 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 | Kliniken der Stadt Köln / Brustzentrum Holweide | Köln | |
| Germany | St. Elisabeth Hospital | Köln | |
| Germany | Unifrauenklinik Köln - Studienzentrum Gynäkologie | Köln | |
| Germany | St. Vincenz KH Limburg | Limburg | |
| Germany | UKSH Campus Lübeck | Luebeck | |
| 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 | Rotkreuzklinikum München, Frauenklinik | Muenchen | |
| Germany | LMU Klinikum/ Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe | München | |
| Germany | Medizinisches Versorgungszentrum für Hämatologie und Onkologie München MVZ GmbH | München | |
| Germany | Gynaekologie Arabella | Munich | |
| 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 | Tuebingen | |
| 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 | |
| Greece | General Hospital of Athens Alexandra Clinic | Athens | Attiki |
| Greece | University General Hospital of Heraklion | Heraklion | Crete |
| Greece | General Hospital of Patras Agios Andreas | Patras | |
| Greece | University General Hospital of Patras | Patras | Western Greece |
| Hong Kong | 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 | |
| Ireland | University College Cork | Cork | |
| Ireland | Mater Misericordiae University Hospital | Dublin | |
| Ireland | Saint Vincents University Hospital | Dublin | Ie-d |
| Ireland | St. James Hospital | Dublin | Leinster |
| Ireland | University Hospital Limerick | Limerick | |
| Israel | Soroka MC | Be'er Sheva | Hadarom |
| Israel | Hadassah Medical Center | Jerusalem | |
| Israel | Rabin Medical Center | Petah tikva | |
| Israel | Sheba Medical Center | Ramat Gan | Tel Aviv |
| 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 | Azienda Ospedaliera Garibaldi-Nesima | Catania | CT |
| Italy | Ospedale Poli SAN MARTINO | Genova | |
| Italy | Area Vasta Sud Est Sede Operativa Grosseto | Grosseto | |
| Italy | Azienda Usl Toscana sud est | Grosseto | |
| Italy | Istituto Europeo di Oncologia | Milan | MI |
| Italy | IRCCS Ospedale San Raffaele | Milano | |
| Italy | University Hospital of Modena | Modena | |
| Italy | INT Fondazione Pascale | Napoli | |
| 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 | |
| Japan | Hyogo Cancer Center | Akashi City | |
| Japan | National Cancer Center (NCC) - Tsukiji Campus - National Cancer Center Hospital (NCCH) | Chuo-Ku | |
| Japan | National Hospital Organization - National Kyushu Cancer Center | Fukuoka City | |
| Japan | Hiroshima City Hiroshima Citizens Hospital | Hiroshima City | |
| Japan | Tokai University Hospital - Isehara Campus | Isehara City | |
| Japan | Sagara Hospital | Kagoshima City | |
| Japan | National Cancer Center Hospital East (NCCHE) - Kashiwa Campus | Kashiwa City | |
| Japan | Japanese Foundation for Cancer Research (JFCR) - The Cancer Institute Hospital - Breast Oncology Center | Koto-Ku | |
| Japan | Kyoto University Hospital | Kyoto | |
| Japan | National Hospital Organization (NHO) - Shikoku Cancer Center | Matsuyama City | |
| Japan | Aichi Cancer Center Hospital | Nagoya City | |
| Japan | Niigata Cancer Center Hospital | Niigata City | |
| Japan | Hyogo College of Medicine Hospital | Nishinomiya City | |
| Japan | Okayama University Hospital | Okayama City | |
| Japan | National Hospital Organization - Osaka National Hospital (ONH) | Osaka City | |
| Japan | Osaka International Cancer Institute (OICI) | Osaka City | |
| Japan | Saitama Cancer Center | Saitama | |
| Japan | National Hospital Organization - Hokkaido Cancer Center | Sapporo City | |
| Japan | Kindai University (Kinki University) - Faculty of Medicine (Kinki University School of Medicine (KUSM)) - Kindai University Hospital (Kinki University Hospital) - Cancer Center | Sayama City | |
| Japan | Tohoku University Hospital (TUH) - Clinical Research, Innovation and Education Center (CRIETO) | Sendai City | |
| Japan | Showa 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 City | |
| Korea, Republic of | Kyungpook National University Hospital | Daegu | |
| Korea, Republic of | CHA Bundang Medical Center CHA University | Gyeonggi-do | |
| Korea, Republic of | National Cancer Center | Gyeonggi-do | |
| Korea, Republic of | Seoul National University Bundang Hospital | Gyeonggi-do | |
| Korea, Republic of | Gachon University Gil Medical Center | Incheon | |
| Korea, Republic of | Samsung Medical Center | Irwon-dong | |
| Korea, Republic of | Korea University Anam Hospital | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Severance Hospital | Seoul | |
| Korea, Republic of | Asan Medical Center | Songpa-gu | |
| Korea, Republic of | Soon Chun Hyang Central Medical Center (SCHMC) | Yongsan | |
| Mexico | Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara | JAL |
| Mexico | Consultorio del Dr. Joaqun Gabriel Reinoso Toledo | Monterrey | Nuevo Leon |
| Mexico | CIMAB S.A. de C.V | Torreon | Coahuila |
| Netherlands | Amsterdam UMC - VU Medisch Centrum | Amsterdam | Noord-Holland |
| Netherlands | Amphia Hospital Breda | Breda | |
| Netherlands | Erasmus MC - Daniel den Hoed Oncologisch Centrum | Rotterdam | |
| Peru | Clinica Ricardo Palma | Lima | |
| Peru | Hospital Nacional Arzobispo Loayza | Lima | |
| Peru | Instituto Nacional de Enfermedades Neoplasicas INEN | Lima | |
| Peru | Centro de Investigación Clinica Trujillo EIRL | Trujillo | |
| Poland | Uniwersyteckie Centrum Kliniczne | Gdansk | Pomorskie |
| Poland | Instytut Centrum Zdrowia Matki Polki | Lódz | |
| Poland | SP Zoz Opolskie Centrum Onkologii IM | Opole | Opolskie |
| Poland | Centrum Medyczne HCP Sp. z o.o. | Poznan | Wielkopolskie |
| Poland | MSCM Cancer Center and Institute of Oncology Department of Breast Cancer and Reconstructive Surgery | Warsaw | |
| Portugal | Hospital da Senhora da Oliveira, Guimarães EPE | Guimarães | |
| Portugal | Centro Hospitalar de Lisboa Ocidental, EPE | Lisboa | |
| Portugal | Fundação Champalimaud | Lisboa | |
| Portugal | Hospital CUF Descobertas | Lisboa | |
| Portugal | Hospital da Luz | Lisboa | |
| Portugal | Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE | Lisboa | |
| Portugal | Hospital Beatriz Ângelo | Loures | |
| Portugal | Unidade Local de Saúde de Matosinhos, EPE | Matosinhos | |
| 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 | |
| Romania | Institutul Oncologic Bucuresti IOB | Bucharest | |
| Romania | Institutul Oncologic Prof. Dr. Ion Chiricuta | Cluj-Napoca | Cluj |
| Romania | Centrul de Oncologie Sfantu Nectarie | Craiova | Dolj |
| Romania | Onco Clinic Consult SA | Craiova | Dolj |
| Russian Federation | SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary | Arkhangel'sk | |
| Russian Federation | State Budgetary Healthcare Institution Oncological Dispensary No. 2 of the Ministry of Health of Krasnodar Region | Sochi | |
| Singapore | National Cancer Center Singapore | Singapore | |
| Singapore | National University Cancer Institute | Singapore | |
| Spain | Hospital Universitario Fundación Alcorcón | Alcorcón | |
| Spain | Hospital de San Juan de Alicante | Alicante | |
| Spain | Hospital General Universitario de Alicante | Alicante | |
| Spain | Hospital Universitario de Badajoz | Badajoz | |
| Spain | ALTHAIA, Xarxa Assistencial Universitària de Manresa F.P. | Barcelona | |
| Spain | Hospital Clínic de Barcelona | Barcelona | |
| Spain | Hospital de Mataró | Barcelona | |
| Spain | Hospital del Mar | Barcelona | |
| Spain | Hospital Universitari Mútua Terrassa | Barcelona | |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
| Spain | ICO Badalona | Barcelona | |
| Spain | ICO Hospitalet | Barcelona | |
| Spain | IOB Institute Of Oncology-Hospital Quironsalud Barcelona | Barcelona | |
| Spain | Hospital Universitario de Basurto | Bilbao | Bizkaia |
| Spain | Hospital Universitario San Pedro de Alcantara | Cáceres | |
| Spain | Consorcio Hospitalario Provincial de Castelló | Castellón | |
| Spain | Complejo Hospitalario Universitario A Coruña (CHUA) | Coruña | |
| Spain | Hospital Clínico Universitario Virgen de la Arrixaca | El Palmar | Murcia |
| 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 | HM Sanchinarro (CIOCC) | Madrid | |
| Spain | Hospital MD Anderson Cancer Center Madrid | Madrid | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario de Fuenlabrada | Madrid | |
| Spain | Hospital Universitario Fundación Jiménez Díaz | Madrid | |
| Spain | Hospital Universitario HM Puerta del Sur | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro de Majadahonda | Madrid | |
| Spain | Hospital Universitario Ramón y Cajal | 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 Son Llatzer | Palma De Mallorca | |
| Spain | Hospital Universitari Son Espases | Palma De Mallorca | |
| Spain | Hospital Universitario Sant Joan Reus | Reus | Tarragona |
| Spain | Hospital Universitario de Canarias | San Cristobal 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 Quirón Salud Sagrado Corazón | Sevilla | |
| Spain | Hospital Universitario Virgen Macarena | Sevilla | |
| Spain | Hospital Universtiario Virgen del Rocio | Sevilla | |
| Spain | Fundación Instituto Valenciano de Oncologia (IVO) | Valencia | |
| Spain | Hospital Arnau de Vilanova de Valencia | Valencia | |
| Spain | Hospital Clínico Universitario de Valencia | Valencia | |
| Spain | Hospital Clínico Universitario Lozano Blesa | Zaragoza | |
| Taiwan | Koo Foundation Sun Yat-Sen Cancer Center | Beitou | |
| Taiwan | Changhua Christian Hospital (CCH) | Chang Hua | |
| Taiwan | E-Da Cancer Hospital | Kaohsiung | Yanchao District |
| Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | |
| Taiwan | China Medical University Hospital | Taichung | |
| Taiwan | Taichung Veterans General Hospital | Taichung | |
| Taiwan | Chi Mei Medical Center CMMC - Yongkang Branch | Tainan | |
| Taiwan | National Cheng Kung University Hospital | Tainan | |
| Taiwan | Chang Gung Memorial Hospital CGMH | Taipei | |
| Taiwan | MacKay Memorial Hospital | Taipei | |
| Taiwan | National Taiwan University Hospital NTUH | Taipei | |
| Taiwan | Taipei Veterans General Hospital TPVGH | Taipei | |
| Taiwan | Tri-Service General Hospital | Taipei | |
| Turkey | Hacettepe University Cancer Institute | Ankara | Iç Anadolu |
| Turkey | Trakya University Medical Faculty | Edirne | |
| Turkey | Istanbul Medeniyet University Medical Faculty | Istanbul | |
| Turkey | Medical Park - Izmir Hastanesi | Izmir | |
| United Kingdom | Royal United Hospital Bath NHS Trust - Royal United Hospital RUH | Bath | Somerset |
| 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 | St. James University Hospital | Leeds | West Yorkshire |
| United Kingdom | Charing Cross Hospital | London | |
| United Kingdom | Guys and St Thomas NHS Foundation Trust | London | |
| United Kingdom | Kent Oncology Centre Maidstone Hospital | Maidstone | Kent |
| United Kingdom | The Christie Hospital | Manchester | Lancashire |
| United Kingdom | Nottingham University Hospitals | Nottingham | Nottinghamshire |
| United Kingdom | Oxford University Hospitals NHS Foundation Trust | Oxford | |
| United Kingdom | Blackpool Victoria Hospital | Peterborough | |
| United Kingdom | Peterborough City Hospital | Peterborough | Cambridgeshire |
| United Kingdom | Somerset NHS Foundation Trust | Taunton | Somerset |
| United Kingdom | Clatterbridge Cancer Centre | Wirral | Merseyside |
| United States | SCRI FCS North- Altamonte | Altamonte Springs | Florida |
| United States | Kaiser Permanente | Anaheim | California |
| United States | The Oncology Institute of Hope & Innovation | Anaheim | California |
| United States | MultiCare Cancer Center Aurburn | Auburn | Washington |
| United States | Kaiser Permanente | Baldwin Park | California |
| United States | MedStar Franklin Square Cancer Center at Loch Raven Campus | Baltimore | Maryland |
| United States | MedStar Franklin Square Medical Center-Harry and Jeanette Weinberg Cancer Institute | Baltimore | Maryland |
| United States | LSU Health Baton Rouge North Clinic | Baton Rouge | Louisiana |
| United States | Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana |
| United States | Our Lady of the Lake Physician Group-Medical Oncology | Baton Rouge | Louisiana |
| United States | Houston Methodist Baytown | Baytown | Texas |
| United States | Kaiser Permanente | Bellflower | California |
| United States | UPMC Upper St. Clair | Bethel Park | Pennsylvania |
| United States | SCRI FCS South- Bonita | Bonita Springs | Florida |
| United States | SCRI FCS North- Brandon Cancer Center | Brandon | Florida |
| United States | Wellmont Medical Associates Oncology & Hematology | Bristol | Virginia |
| United States | Montefiore Medical Center | Bronx | New York |
| United States | SCRI FCS South- North Fort Myers | Cape Coral | Florida |
| United States | Waverly Hematology Oncology | Cary | North Carolina |
| United States | University of Virginia | Charlottesville | Virginia |
| United States | SCRI FCS North- Mease/Clearwater | Clearwater | Florida |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | Cleveland Clinic - Hillcrest | Cleveland | Ohio |
| United States | Cleveland Clinic-Fairview | Cleveland | Ohio |
| United States | Ochsner Hematology Oncology North Shore - Covington (West Region) | Covington | Louisiana |
| United States | UPMC Passavant Cranberry/North | Cranberry Township | Pennsylvania |
| United States | Elmhurst Memorial Hospital- Nancy W. Knowles Cancer Center | Elmhurst | Illinois |
| United States | AHN Cancer Inst at St Vincent | Erie | Pennsylvania |
| United States | UPMC Erie | Erie | Pennsylvania |
| United States | Kaiser Permanente | Fontana | California |
| 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 | Orange Coast Blood and Cancer Care | Fountain Valley | California |
| United States | SCRI TO Nashville- Franklin Tennessee Oncology, PLLC | Franklin | Tennessee |
| United States | Frederick Health-James M Stockman Cancer Center | Frederick | Maryland |
| United States | SCRI FCS North- Gainesville Cancer Center | Gainesville | Florida |
| United States | SCRI TO Nashville- Gallatin Tennessee Oncology, PLLC | Gallatin | Tennessee |
| United States | MultiCare Regional Cancer Center - Gig Harbor | Gig Harbor | Washington |
| United States | UPMC Arnold Palmer-Mt View | Greensburg | Pennsylvania |
| United States | Kaiser Permanente | Harbor City | California |
| United States | UMPC Pinnacle Pharmacy | Harrisburg | Pennsylvania |
| United States | UPMC Pinnacle-Ortenzio Cancer Center | Harrisburg | Pennsylvania |
| United States | SCRI TO Nashville- Hendersonville Tennessee Oncology, PLLC | Hendersonville | Tennessee |
| United States | SCRI TO Nashville- Summit Tennessee Oncology, PLLC | Hermitage | Tennessee |
| United States | Houston Methodist | Houston | Texas |
| United States | Houston Methodist West | Houston | Texas |
| United States | Houston Methodist Willowbrook | Houston | Texas |
| United States | Kaiser Permanente | Irvine | California |
| United States | Baptist MD Anderson Cancer Center | Jacksonville | Florida |
| United States | AHN Cancer Insititute at Jefferson | Jefferson Hills | Pennsylvania |
| United States | Regional Cancer Center at Indian Path Community Hospital | Kingsport | Tennessee |
| United States | SCRI FCS North- Villages East | Lady Lake | Florida |
| United States | SCRI FCS South- Lakewood Ranch | Lakewood Ranch | Florida |
| United States | SCRI FCS North- Largo/Highland | Largo | Florida |
| United States | SCRI TO Nashville- Lebanon Tennessee Oncology, PLLC | Lebanon | Tennessee |
| United States | SCRI FCS North- Lecanto | Lecanto | Florida |
| United States | University of Kentucky, Markey Cancer Center, Clinical Research Organization | Lexington | Kentucky |
| United States | Long Beach Memorial TCI | Long Beach | California |
| United States | Kaiser Permanente | Los Angeles | California |
| United States | Baptist Health Louisville | Louisville | Kentucky |
| United States | AHN Cancer Institute at Forbes | Monroeville | Pennsylvania |
| United States | UPMC Monroeville | Monroeville | Pennsylvania |
| United States | West Virginia University | Morgantown | West Virginia |
| United States | UPMC Arnold Palmer-Mt Pleasant | Mount Pleasant | Pennsylvania |
| United States | UPMC Arnold Palmer-Norwin | N. Huntingdon | Pennsylvania |
| United States | Edward Cancer Center | Naperville | Illinois |
| United States | SCRI FCS South- Naples West | Naples | Florida |
| United States | SCRI FCS South- Naples/Goodlette | Naples | Florida |
| 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- St. Thomas Midtown Tennessee Oncology, PLLC | Nashville | Tennessee |
| United States | SCRI TO Nashville- St. Thomas West Tennessee Oncology, PLLC | Nashville | Tennessee |
| United States | Tennessee Oncology Nashville / Sarah Cannon | Nashville | Tennessee |
| United States | Houston Methodist Clear Lake | Nassau Bay | Texas |
| United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
| 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 | Kaiser Permanente | Ontario | California |
| 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 | Kaiser Permanente | Panorama City | California |
| United States | AHN Cancer Inst at West Penn | Pittsburgh | Pennsylvania |
| United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
| United States | Magee | 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 St. Margaret | Pittsburgh | Pennsylvania |
| United States | Edward Cancer Center Plainfield | Plainfield | Illinois |
| United States | SCRI FCS South- Port Charlotte | Port Charlotte | Florida |
| United States | MultiCare Cancer Center Puyallup | Puyallup | Washington |
| United States | Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia |
| United States | Kaiser Permanente | Riverside | California |
| United States | UNC Cancer Care at Nash | Rocky Mount | North Carolina |
| United States | SCRI FCS North | Saint Petersburg | Florida |
| United States | SCRI FCS North- St. Anthony's/St. Petersburg | Saint Petersburg | Florida |
| United States | Kaiser Permanente | San Diego | California |
| United States | Kaiser Permanente | San Marcos | California |
| United States | SCRI FCS South- Sarasota-Cattleman | Sarasota | Florida |
| United States | SCRI FCS South-Sarasota-Downtown | Sarasota | Florida |
| United States | Holy Cross Hospital | Silver Spring | Maryland |
| United States | Maryland Oncology Hematology | Silver Spring | Maryland |
| United States | SCRI TO Nashville- Smyrna Tennessee Oncology, PLLC | Smyrna | Tennessee |
| United States | MultiCare Institute for Research & Innovation | Spokane | Washington |
| United States | MultiCare Institute for Research & Innovation | Spokane | Washington |
| United States | SCRI FCS North- Spring Hill | Spring Hill | Florida |
| United States | Houston Methodist Sugarland | Sugar Land | Texas |
| United States | MultiCare Cancer Center Tacoma | Tacoma | Washington |
| United States | SCRI FCS North- Tampa Cancer Center | Tampa | Florida |
| United States | SCRI FCS North- Tavares | Tavares | Florida |
| United States | Houston Methodist Woodlands | The Woodlands | Texas |
| United States | UPMC Uniontown | Uniontown | Pennsylvania |
| United States | SCRI FCS South- Venice Healthpark | Venice | Florida |
| United States | Cleveland Clinic South Pointe | Warrensville Heights | Ohio |
| United States | UPMC Washington | Washington | Pennsylvania |
| United States | Kaiser Permanente | West Los Angeles | California |
| United States | Reading Hospital, McGlinn Cancer Institute | West Reading | Pennsylvania |
| United States | Cleveland Clinic-Weston | Weston | Florida |
| United States | AHN Cancer Institute at Wexford | Wexford | Pennsylvania |
| United States | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina |
| United States | SCRI FCS North- Winter Park | Winter Park | Florida |
| United States | Kaiser Permanente | Woodland Hills | California |
| United States | UPMC Pinnacle-Memorial Cancer Center | York | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Daiichi Sankyo, Inc. | AstraZeneca, German Breast Group, NSABP Foundation Inc, Spanish Breast Cancer Research Group (SOLTI) |
United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russian Federation, Singapore, Spain, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Invasive Disease-free Survival (IDFS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment | 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 | Disease-free Survival (DFS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment | 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 | ||
| Secondary | Overall Survival (OS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment | Randomization to date of death from any cause, up to approximately 81 months postdose | ||
| Secondary | Distant Recurrence-free Interval (DRFI) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment | Randomization to date of distant recurrence, up to approximately 81 months postdose | ||
| Secondary | Brain Metastases-free Interval (BMFI) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment | Randomization to date of brain metastasis, up to approximately 81 months postdose | ||
| Secondary | Percentage of Treatment-emergent Adverse Events in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment | Baseline up to approximately 81 months postdose | ||
| Secondary | Serum Concentrations of Trastuzumab Deruxtecan (T-DXd), total anti-HER2 antibody, and Active Metabolite MAAA-1181a | 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) | ||
| Secondary | Percentage of Participants Positive for Treatment-emergent Anti-drug Antibodies (ADAs) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) | Baseline up to approximately 81 months postdose |