Clinical trial NCT03523585: DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
Official title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast Cancer
Metastatic breast cancer
DS 8201a
DESTINY - Breast 02
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo Co., Ltd.
name: AstraZeneca
First posted: 2018-05-14
Enrollment: 608
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare DS 8201a to standard treatment.

Participants must have HER2 breast cancer that has been treated before.

Their cancer:

* cannot be removed by an operation
* has spread to other parts of the body

Detailed description: The study is designed to compare DS 8201a versus standard of care (investigator's choice) in subjects with unresectable and/or metastatic breast cancer previously treated with T-DM1.

Eligibility criteria: Inclusion Criteria:

* Is the age of majority in their country
* Has pathologically documented breast cancer that:

  1. is unresectable or metastatic
  2. has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
  3. 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:

  1. 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males)
  2. 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)
  3. 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

Primary outcomes:
measure: Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
timeFrame: Baseline up to 46 months postdose
Secondary outcomes:
measure: Overall Survival (OS) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
timeFrame: Baseline up to 46 months postdose
measure: Percentage of Participants With Objective Response Rate (ORR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
timeFrame: Baseline up to 46 months postdose
measure: Duration of Response (DoR) Based on BICR in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
timeFrame: Baseline up to 46 months postdose
measure: Progression-Free Survival (PFS) Based on Investigator Assessment in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
timeFrame: Up to 46 months
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer Research Centers
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Hematology Oncology - Main Site
state: California
city: Monterey
country: United States
facility: Pacific Cancer Care
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Whittier
country: United States
facility: Innovative Clinical Research Institute
state: California
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale New Haven
state: Connecticut
city: Washington
country: United States
facility: Washington Cancer Institute
state: District of Columbia
city: Fort Myers
country: United States
facility: Florida Cancer Specialists-Broadway
state: Florida
city: Atlanta
country: United States
facility: Piedmont Cancer Institute, PC
state: Georgia
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children/Univ of HI
state: Hawaii
city: Maywood
country: United States
facility: Loyola University Health System
state: Illinois
city: Munster
country: United States
facility: Community Hospital
state: Indiana
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine
state: Maine
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Joplin
country: United States
facility: Cornell-Beshore Cancer Institute
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's Cancer Institute
state: Missouri
city: Kansas City
country: United States
facility: Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: East Setauket
country: United States
facility: North Shore Hematology Oncology Associates, PC
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Kettering
country: United States
facility: Dayton Physicians, LLC
state: Ohio
city: Philadelphia
country: United States
facility: Abramson Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Center
state: Pennsylvania
city: Chattanooga
country: United States
facility: Tennessee Oncology, PLLC Chattanooga
state: Tennessee
city: Germantown
country: United States
facility: The West Clinic
state: Tennessee
city: Nashville
country: United States
facility: SCRI - Tennessee Oncology
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler
state: Texas
city: Ogden
country: United States
facility: Community Cancer Trials of Utah
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Tacoma
country: United States
facility: MultiCare Health System Institute for Research and Innovation
state: Washington
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Tweed Heads
country: Australia
facility: The Tweed Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre Research
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Frankston
country: Australia
facility: Peninsula and South Eastern Haematology & Oncology Group
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Saint Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Warrnambool
country: Australia
facility: South West Oncology
state: Victoria
city: Wendouree
country: Australia
facility: Ballarat Oncology & Haematology Service
state: Victoria
city: Subiaco
country: Australia
facility: St John of God Subiaco Hospital
state: Western Australia
city: Bruce
country: Australia
facility: Calvary North Adelaide Hospital
city: Bruxelles
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Kortrijk
country: Belgium
facility: Az Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven
city: Namur
country: Belgium
facility: CHU UCL Namur site de Sainte Elisabeth
city: Salvador
country: Brazil
facility: NOB - Núcleo de Oncologia da Bahia
state: Bahia
city: Salvador
country: Brazil
facility: AMO - Assistência Multidisciplinar em Oncologia
state: Bahia
city: Fortaleza
country: Brazil
facility: Pronutrir
state: Ceará
city: Nova Lima
country: Brazil
facility: Oncobio Servicos de Saude
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: HGB - Hospital Giovanni Battista - Mãe de Deus Center
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: CliniOnco - Tratamento Integrado do Câncer
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Escosteguy Barrios, Carlos Henrique
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição
state: Rio Grande Do Sul
city: Itajaí
country: Brazil
facility: Clínica de Neoplasias Litoral Ltda.
state: Santa Catarina
city: Santo André
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
state: Sao Paulo
city: São Paulo
country: Brazil
facility: IBCC - Instituto Brasileiro de Controle do Câncer
state: Sao Paulo
city: Rio De Janeiro
country: Brazil
facility: COI - Clínicas Oncológicas Integradas
city: São Paulo
country: Brazil
facility: Sociedade Beneficiente de Senhoras Hospital Sírio Libanês
city: São Paulo
country: Brazil
facility: A. C. Camargo Cancer Center
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Prague 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Praha
country: Czechia
facility: Nemocnice Na Bulovce
city: Marseille cedex 20
country: France
facility: Hôpital Nord - CHU Marseille
state: Bouches-du-Rhône
city: Caen Cedex 05
country: France
facility: Centre François Baclesse
state: Calvados
city: Plérin
country: France
facility: CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
state: Cotes d'Armor
city: Dijon cedex
country: France
facility: Centre Georges François Leclerc
state: Côte-d'Or
city: Besançon
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
state: Doubs
city: Brest Cedex
country: France
facility: CHU Brest - Hôpital Morvan
state: Finistere
city: Antony
country: France
facility: Hôpital Privé d'Antony
state: Hauts De Seine
city: Saint-Cloud
country: France
facility: Centre René Huguenin
state: Hauts De Seine
city: Montpellier
country: France
facility: Clinique Clementville
state: Herault
city: Montpellier
country: France
facility: Institut Régional du Cancer de Montpellier
state: Herault
city: Rennes cedex
country: France
facility: CRLCC Eugene Marquis
state: Ille Et Vilaine
city: Lille cedex
country: France
facility: Centre Oscar Lambret
state: Nord
city: Valenciennes
country: France
facility: Centre de cancerologie les Dentellieres
state: Nord
city: Paris Cedex 05
country: France
facility: Institut Curie - site de Paris
state: Paris
city: Bayonne Cedex
country: France
facility: Centre Hospitalier de la côte Basque
state: Pyrenees Atlantiques
city: Pierre Benite cedex
country: France
facility: Centre Hospitalier Lyon Sud
state: Rhone
city: Le Mans Cedex 02
country: France
facility: Clinique Victor Hugo - Centre Jean Bernard
state: Sarthe
city: Rouen
country: France
facility: Centre Henri Becquerel
state: Seine Maritime
city: Avignon Cedex 9
country: France
facility: Institut Sainte Catherine
state: Vaculuse
city: Villejuif cedex
country: France
facility: Institut Gustave Roussy
state: Val De Marne
city: Montpellier
country: France
facility: Institut Régional du Cancer de Montpellier
city: Paris
country: France
facility: Institut Curie - site de Paris
city: Paris
country: France
facility: Hopital Tenon
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar der TU Muenchen
state: Bayern
city: Bottrop
country: Germany
facility: Marienhospital Bottrop gGmbH
state: Rheinland Pfalz
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
state: Schleswig Holstein
city: Berlin
country: Germany
facility: Helios-Kliniken Berlin-Buch
city: Düsseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf AoeR
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
city: Koeln
country: Germany
facility: Kliniken Koeln
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig AoeR
city: Munich
country: Germany
facility: Klinikum der Universitaet Muenchen - Campus Grosshardern
city: Müenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Troisdorf
country: Germany
facility: Haematologisch-Onkologische Schwerpunktpraxis
city: Athens
country: Greece
facility: 251 General Air Force Hospital
city: Athens
country: Greece
facility: General Hospital of Athens "Alexandra"
city: Athens
country: Greece
facility: General Oncology Hospital of Kifissia " Agioi Anargyroi"
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
city: Thessaloníki
country: Greece
facility: Euromedica General Clinic Thessaloniki
city: Haifa
country: Israel
facility: Rambam Health Care Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Kfar Saba
country: Israel
facility: Sapir Medical Center, Meir Hospital
city: Petah tikva
country: Israel
facility: Rabin Medical Center-Beilinson Campus
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Monza
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
state: Milano
city: Aviano
country: Italy
facility: IRCCS Centro di Riferimento Oncologico
state: Pordenone
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore Don Calabria
state: Verona
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
city: Cona
country: Italy
facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
city: Genova
country: Italy
facility: Istituto Nazionale per la Ricerca sul Cancro di Genova
city: Lecco
country: Italy
facility: Azienda Ospealiera della Provincia di Lecco
city: Messina
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: IEO Istituto Europeo di Oncologia
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione G. Pascale
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto IRCCS
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital
state: Fukushima-Ken
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka-Fu
city: Ōsakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka-Fu
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo-To
city: Ehime
country: Japan
facility: NHO Shikoku Cancer Center
city: Fukuoka
country: Japan
facility: NHO Kyushu Cancer Center
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
city: Hokkaido
country: Japan
facility: NHO Hokkaido Cancer Center
city: Hyōgo
country: Japan
facility: Hyōgo College of Medicine Hospital
city: Kanagawa
country: Japan
facility: St. Marianna University School of Medicine Hospital
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Miyagi
country: Japan
facility: Tohoku University Hospital
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: NHO Osaka National Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: Toranomon Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Badalona
country: Spain
facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: ICO l'Hospitalet - Hospital Duran i Reynals
state: Barcelona
city: Jerez De La Frontera
country: Spain
facility: Hospital de Especialidades de Jerez de la Frontera
state: Cádiz
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
state: La Coruña
city: San Cristobal de la Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Barcelona
country: Spain
facility: Hospital Quironsalud Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: MD Anderson Cancer Centre
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Málaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia IVO
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Adana
country: Turkey
facility: Acibadem Adana Hospital
city: Adana
country: Turkey
facility: Adana Numune Training and Research Hospital
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazit Uni. Med. Fac.Ankara City Hospital
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Bursa
country: Turkey
facility: Uludag University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital
city: Istanbul
country: Turkey
facility: Medipol University Medical Faculty
city: Istanbul
country: Turkey
facility: Medical Park Goztepe Hospital
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet Uni Goztepe Training & Research Hospital
city: Istanbul
country: Turkey
facility: Kartal Lutfi Kirdar Research and Training Hospital
city: İzmir
country: Turkey
facility: Izmir Medicalpark Hospital
city: Konya
country: Turkey
facility: Konya Necmettin Erbakan University Meram Faculty of Medicine
city: Sakarya
country: Turkey
facility: Sakarya Traning and Research Hospital
city: Samsun
country: Turkey
facility: Medical Park Samsun Hastanesi
city: Tekirdağ
country: Turkey
facility: Namik Kemal University
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital (Wonford)
state: Devon
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: Devon
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Grampian Region
city: London
country: United Kingdom
facility: Queen Mary University of London
state: Greater London
city: London
country: United Kingdom
facility: University College London Hospitals
state: Greater London
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
state: Greater London
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: Lothian Region
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals City Campus
state: Nottinghamshire
Study officials:
affiliation: Daiichi Sankyo
name: Global Team Leader
role: STUDY_DIRECTOR
References:
citation: Andre F, Hee Park Y, Kim SB, Takano T, Im SA, Borges G, Lima JP, Aksoy S, Gavila Gregori J, De Laurentiis M, Bianchini G, Roylance R, Miyoshi Y, Armstrong A, Sinha R, Ruiz Borrego M, Lim E, Ettl J, Yerushalmi R, Zagouri F, Duhoux FP, Fehm T, Gambhire D, Cathcart J, Wu C, Chu C, Egorov A, Krop I. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 May 27;401(10390):1773-1785. doi: 10.1016/S0140-6736(23)00725-0. Epub 2023 Apr 20.
citation: Fehm T, Cottone F, Dunton K, Andre F, Krop I, Park YH, De Laurentiis M, Miyoshi Y, Armstrong A, Borrego MR, Yerushalmi R, Duhoux FP, Takano T, Lu W, Egorov A, Kim SB. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): patient-reported outcomes from a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2024 May;25(5):614-625. doi: 10.1016/S1470-2045(24)00128-1.