DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]
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 03
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 trastuzumab and taxane in the advanced/metastatic setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane
- 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.
- If of reproductive/childbearing potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study for 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males) or 7 months after the last dose of T-DM1
- Has adequate renal and hepatic function
Exclusion Criteria:
- Has previously been treated with an anti-HER2 antibody drug conjugate (ADC) in the metastatic setting. 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 uncontrolled or significant cardiovascular disease
- Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
- Participants with clinically inactive brain metastases may be included in the study.
- Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.
Sites / Locations
- UCLA Hematology Oncology
- Sharp Memorial Hospital
- University of California San Francisco
- Innovative Clinical Research Institute
- Washington Cancer Institute
- Florida Cancer Specialists-Broadway
- Florida Cancer Specialists NORTH
- Piedmont Cancer Institute, PC
- Loyola University Health System
- Norton Cancer Institute
- Dana-Farber Cancer Institute
- University of Nebraska Medical Center
- North Shore Hematology Oncology Associates, PC
- University of Rochester
- Wake Forest University Baptist Medical Center
- University of Cincinnati Medical Center
- Seidman Cancer Center
- The Ohio State University
- Dayton Physicians, LLC
- Magee-Womens Hospital of UPMC
- Tennessee Oncology- St Thomas Location
- Vanderbilt Breast Center at One Hundred Oaks
- UT Southwestern Medical Center
- Houston Methodist Hospital / Houston Methodist Cancer Center
- MD Anderson Cancer Center
- Millennium Oncology
- The University of Texas Health Science Center at Tyler
- MultiCare Health System Institute for Research and Innovation
- The Tweed Hospital
- Princess Alexandra Hospital
- Box Hill Hospital
- Peninsula and South Eastern Haematology & Oncology Group
- Peter MacCallum Cancer
- St John of God Subiaco Hospital
- Institut Jules-Bordet
- Universitair Ziekenhuis Brussel
- Universitair Ziekenhuis Antwerpen
- AZ Sint-Lucas - Campus Sint-Lucas
- Universitaire Ziekenhuizen Leuven
- CHU UCL Namur site de Sainte Elisabeth
- NOB - Nucleo de Oncologia da Bahia
- Hospital Nossa Senhora da Conceição
- Clínica de Neoplasias Litoral Ltda.
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
- ICESP - Instituto do Cancer do Estado de São Paulo Octavio Frias de Oliveira
- Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda.
- COI - Clínicas Oncológicas Integradas
- A. C. Camargo Cancer Center
- Tom Baker Cancer Centre
- Toronto Sunnybrook Hospital
- St. Mary's Hospital
- Cancer Hospital Chinese Academy of Medical Sciences
- Beijing Hospital
- Sun Yat-sen University, Cancer Center
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Harbin Medical University Cancer Hospital
- The First Hospital of Jilin University
- Liaoning Cancer Hospital & Institute
- Fudan University Shanghai Cancer Center
- West China Hospital, Sichuan University
- Tianjin Medical University Cancer Institute & Hospital
- Sir Run Run Shaw Hospital Xiasha Branch, Zhejiang University, School of Medicine
- Zhejiang Cancer Hospital
- Centre Paul Strauss
- Hôpital Nord - CHU Marseille
- Centre François Baclesse
- Clinique Victor Hugo - Centre Jean Bernard
- CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
- Centre Georges François Leclerc
- CHRU Jean Minjoz
- Institut Bergonié
- Centre René Huguenin
- ICM Val d'Aurelle
- CRLCC Eugene Marquis
- Institut de cancérologie de l'ouest, site René Gauducheau
- ICO - Site Paul Papin
- Centre de cancerologie les Dentellieres
- Centre Leon Berard
- Centre Hospitalier Lyon Sud
- Institut Sainte Catherine
- Hôpital d'Instruction des Armees Begin*
- Institut Gustave Roussy
- Institut Curie - site de Paris
- Hôpital Saint-Louis
- Hopital Tenon
- Universitaetsklinikum Erlangen
- Rotkreuzklinikum Muenchen gGmbH
- Klinikum rechts der Isar der TU Muenchen
- Universitaetsklinikum Duesseldorf AoeR
- Haematologisch-Onkologische Schwerpunktpraxis
- Marienhospital Bottrop gGmbH
- Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
- Queen Mary Hospital
- Chinese University of Hong Kong
- Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
- Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), U.O Oncologia Medica
- Istituto Clinico Humanitas
- IRCCS Centro di Riferimento Oncologico
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
- Istituto Nazionale per la Ricerca sul Cancro di Genova
- Azienda Ospealiera della Provincia di Lecco
- Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
- Ospedale San Raffaele
- IEO Istituto Europeo di Oncologia
- A.O.U. Policlinico di Modena
- Istituto Nazionale Tumori Fondazione G. Pascale
- Azienda Ospedaliero Universitaria di Parma
- Fondazione IRCCS Policlinico San Matteo
- Azienda Ospedaliera Città della Salute e della Scienza di Torino
- Center Hospital of the National Center for Global Health and Medicine
- Aichi Cancer Center Hospital
- NHO Shikoku Cancer Center
- NHO Kyushu Cancer Center
- Hiroshima City Hiroshima Citizens Hospital
- NHO Hokkaido Cancer Center
- Kanagawa Cancer Center
- Kumamoto University Hospital
- Niigata Cancer Center
- Okayama University Hospital
- NHO Osaka National Hospital
- Osaka International Cancer Institute
- Saitama Cancer Center
- Shizuoka Cancer Center
- National Cancer Center Hospital
- The Cancer Institute Hospital of JFCR
- Showa University Hospital
- Seoul National University Bundang Hospital
- Seoul National University Hospital
- Severance Hospital, Yonsei University
- Asan Medical Center
- Samsung Medical Center
- ICO l'Hospitalet - Hospital Duran i Reynals
- Complejo Hospitalario Universitario A Coruña
- Complejo Hospitalario Universitario de Santiago
- Hospital Universitario Puerta de Hierro Majadahonda
- Hospital Universitario Virgen Macarena
- Hospital Universitario de Canarias
- Hospital Infanta Cristina
- Hospital Universitari Vall d'Hebron
- Hospital Clinic de Barcelona
- IOB-Institute of Oncology
- Hospital General Universitario Gregorio Maranon
- MD Anderson Cancer Centre
- Hospital Universitario Ramon y Cajal
- Hospital Universitario Clinico San Carlos
- Hospital Universitario 12 de Octubre
- Hospital Clinico Universitario Virgen de la Victoria
- Hospital Universitario Virgen del Rocio
- China Medical University Hospital
- National Cheng Kung University Hospital
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Koo Foundation, Sun Yat-Sen Cancer Center
- Royal Devon and Exeter Hospital (Wonford)
- Aberdeen Royal Infirmary
- Queen Mary University of London
- University College London Hospitals
- Guy's Hospital
- Sarah Cannon Research Institute UK
- The Christie NHS Foundation Trust
- Western General Hospital
- Nottingham University Hospitals City Campus
- Royal Surrey County Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Trastuzumab deruxtecan (T-DXd)
Ado-trastuzumab emtansine (T-DM1)
Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.