DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Metastatic breast cancer, DS 8201a, DESTINY - Breast 02
Eligibility Criteria
Inclusion Criteria:
- Is the age of majority in their country
Has pathologically documented breast cancer that:
- is unresectable or metastatic
- has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
- was previously treated with ado-trastuzumab emtansine (T-DM1)
- Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy)
- Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.
Male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least:
- 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males)
- 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)
- 7 months after the last dose of trastuzumab/capecitabine
- Has adequate hematopoietic, renal and hepatic functions
Exclusion Criteria:
- Has previously participated in an antibody drug conjugate study sponsored by Daiichi Sankyo. Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy
- Has had prior treatment with capecitabine
- Has uncontrolled or significant cardiovascular disease
- Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- Has active central nervous system (CNS) metastases
Sites / Locations
- Ironwood Cancer Research Centers
- UCLA Hematology Oncology - Main Site
- Pacific Cancer Care
- Sharp Memorial Hospital
- Innovative Clinical Research Institute
- Smilow Cancer Hospital at Yale New Haven
- Washington Cancer Institute
- Florida Cancer Specialists-Broadway
- Piedmont Cancer Institute, PC
- Kapiolani Medical Center for Women and Children/Univ of HI
- Loyola University Health System
- Community Hospital
- Norton Cancer Institute
- Maine Center for Cancer Medicine
- University of Maryland
- Beth Israel Deaconess Medical Center
- Dana Farber Cancer Institute
- Henry Ford Hospital
- Cornell-Beshore Cancer Institute
- Saint Luke's Cancer Institute
- Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC
- Washington University
- North Shore Hematology Oncology Associates, PC
- Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
- University of Cincinnati Medical Center
- Cleveland Clinic Main Campus
- The Ohio State University
- Dayton Physicians, LLC
- Abramson Cancer Center
- Allegheny General Hospital
- UPMC Cancer Center
- Tennessee Oncology, PLLC Chattanooga
- The West Clinic
- SCRI - Tennessee Oncology
- UT Southwestern Medical Center
- MD Anderson Cancer Center
- The Methodist Hospital Research Institute
- The University of Texas Health Science Center at Tyler
- Community Cancer Trials of Utah
- Virginia Cancer Specialists, PC
- MultiCare Health System Institute for Research and Innovation
- St Vincent's Hospital Sydney
- Liverpool Hospital
- Macquarie University Hospital
- The Tweed Hospital
- Princess Alexandra Hospital
- Ashford Cancer Centre Research
- Box Hill Hospital
- Frankston Hospital
- Peninsula and South Eastern Haematology & Oncology Group
- Austin Health
- Peter MacCallum Cancer Centre
- Sunshine Hospital
- South West Oncology
- Ballarat Oncology & Haematology Service
- St John of God Subiaco Hospital
- Calvary North Adelaide Hospital
- Universitair Ziekenhuis Brussel
- Cliniques Universitaires Saint-Luc
- AZ Maria Middelares
- Az Groeninge
- UZ Leuven
- CHU UCL Namur site de Sainte Elisabeth
- NOB - Núcleo de Oncologia da Bahia
- AMO - Assistência Multidisciplinar em Oncologia
- Pronutrir
- Oncobio Servicos de Saude
- HGB - Hospital Giovanni Battista - Mãe de Deus Center
- CliniOnco - Tratamento Integrado do Câncer
- Escosteguy Barrios, Carlos Henrique
- Hospital Nossa Senhora da Conceição
- Clínica de Neoplasias Litoral Ltda.
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
- IBCC - Instituto Brasileiro de Controle do Câncer
- COI - Clínicas Oncológicas Integradas
- Sociedade Beneficiente de Senhoras Hospital Sírio Libanês
- A. C. Camargo Cancer Center
- Fakultni nemocnice Brno
- Fakultni nemocnice Olomouc
- Fakultni nemocnice v Motole
- Nemocnice Na Bulovce
- Hôpital Nord - CHU Marseille
- Centre François Baclesse
- CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
- Centre Georges François Leclerc
- CHU Besançon - Hôpital Jean Minjoz
- CHU Brest - Hôpital Morvan
- Hôpital Privé d'Antony
- Centre René Huguenin
- Clinique Clementville
- Institut Régional du Cancer de Montpellier
- CRLCC Eugene Marquis
- Centre Oscar Lambret
- Centre de cancerologie les Dentellieres
- Institut Curie - site de Paris
- Centre Hospitalier de la côte Basque
- Centre Hospitalier Lyon Sud
- Clinique Victor Hugo - Centre Jean Bernard
- Centre Henri Becquerel
- Institut Sainte Catherine
- Institut Gustave Roussy
- Institut Régional du Cancer de Montpellier
- Institut Curie - site de Paris
- Hopital Tenon
- Klinikum rechts der Isar der TU Muenchen
- Marienhospital Bottrop gGmbH
- Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
- Helios-Kliniken Berlin-Buch
- Universitaetsklinikum Duesseldorf AoeR
- Universitaetsklinikum Erlangen
- Kliniken Koeln
- Universitaetsklinikum Leipzig AoeR
- Klinikum der Universitaet Muenchen - Campus Grosshardern
- Universitaetsklinikum Muenster
- Haematologisch-Onkologische Schwerpunktpraxis
- 251 General Air Force Hospital
- General Hospital of Athens "Alexandra"
- General Oncology Hospital of Kifissia " Agioi Anargyroi"
- University General Hospital of Heraklion
- Euromedica General Clinic Thessaloniki
- Rambam Health Care Center
- Shaare Zedek Medical Center
- Hadassah University Hospital - Ein Kerem
- Sapir Medical Center, Meir Hospital
- Rabin Medical Center-Beilinson Campus
- Chaim Sheba Medical Center
- Tel Aviv Sourasky Medical Center
- Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
- IRCCS Centro di Riferimento Oncologico
- Ospedale Sacro Cuore Don Calabria
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
- Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
- Istituto Nazionale per la Ricerca sul Cancro di Genova
- Azienda Ospealiera della Provincia di Lecco
- Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
- Ospedale San Raffaele
- Fondazione IRCCS Istituto Nazionale dei Tumori
- IEO Istituto Europeo di Oncologia
- A.O.U. Policlinico di Modena
- Istituto Nazionale Tumori Fondazione G. Pascale
- IOV - Istituto Oncologico Veneto IRCCS
- Azienda Ospedaliero Universitaria di Parma
- Fondazione IRCCS Policlinico San Matteo
- Azienda Ospedaliero Universitaria Pisana
- Azienda Ospedaliera Città della Salute e della Scienza di Torino
- Fukushima Medical University Hospital
- Kindai University Hospital
- Kindai University Hospital
- National Cancer Center Hospital
- NHO Shikoku Cancer Center
- NHO Kyushu Cancer Center
- Hiroshima City Hiroshima Citizens Hospital
- NHO Hokkaido Cancer Center
- Hyōgo College of Medicine Hospital
- St. Marianna University School of Medicine Hospital
- Kanagawa Cancer Center
- Kyoto University Hospital
- Tohoku University Hospital
- Aichi Cancer Center Hospital
- Niigata Cancer Center Hospital
- Okayama University Hospital
- NHO Osaka National Hospital
- Osaka International Cancer Institute
- Saitama Cancer Center
- Shizuoka Cancer Center
- Toranomon Hospital
- The Cancer Institute Hospital of JFCR
- Tokyo Medical University Hospital
- Chungbuk National University Hospital
- Inha University Hospital
- Seoul National University Bundang Hospital
- The Catholic University of Korea, St. Vincent's Hospital
- Ajou University Hospital
- Kyungpook National University Chilgok Hospital
- National Cancer Center
- Korea University Anam Hospital
- Seoul National University Hospital
- Severance Hospital, Yonsei University
- Asan Medical Center
- Samsung Medical Center
- The Catholic University of Korea, Seoul St. Mary's Hospital
- ICO Badalona - Hospital Universitari Germans Trias i Pujol
- ICO l'Hospitalet - Hospital Duran i Reynals
- Hospital de Especialidades de Jerez de la Frontera
- Complejo Hospitalario Universitario A Coruña
- Hospital Universitario de Canarias
- Hospital Infanta Cristina
- Hospital Quironsalud Barcelona
- Hospital Universitari Vall d'Hebron
- Hospital Clinic de Barcelona
- Hospital del Mar
- Hospital Universitari Arnau de Vilanova
- Hospital General Universitario Gregorio Marañon
- MD Anderson Cancer Centre
- Hospital Universitario Clinico San Carlos
- Hospital Clinico Universitario Virgen de la Victoria
- Hospital Universitario de Salamanca
- Hospital Universitario Virgen Macarena
- Hospital Universitario Virgen del Rocio
- Instituto Valenciano de Oncologia IVO
- Hospital Universitario Miguel Servet
- Acibadem Adana Hospital
- Adana Numune Training and Research Hospital
- Ankara Yildirim Beyazit Uni. Med. Fac.Ankara City Hospital
- Akdeniz University Medical Faculty
- Uludag University Medical Faculty
- Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
- Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital
- Medipol University Medical Faculty
- Medical Park Goztepe Hospital
- Istanbul Medeniyet Uni Goztepe Training & Research Hospital
- Kartal Lutfi Kirdar Research and Training Hospital
- Izmir Medicalpark Hospital
- Konya Necmettin Erbakan University Meram Faculty of Medicine
- Sakarya Traning and Research Hospital
- Medical Park Samsun Hastanesi
- Namik Kemal University
- Royal Cornwall Hospital
- Royal Devon and Exeter Hospital (Wonford)
- Derriford Hospital
- Aberdeen Royal Infirmary
- Queen Mary University of London
- University College London Hospitals
- Sarah Cannon Research Institute UK
- Western General Hospital
- Nottingham University Hospitals City Campus
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Trastuzumab deruxtecan (DS-8201a)
Trastuzumab+capecitabine
Lapatinib+capecitabine
HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to treatment with DS-8201a
HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Trastuzumab/capecitabine
HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Lapatinib/capecitabine