Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

Trial Title: Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

NCT ID: NCT03734029

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Camptothecin
Albumin-Bound Paclitaxel
Gemcitabine
Capecitabine
Trastuzumab
Trastuzumab deruxtecan
Immunoconjugates

Conditions: Keywords:
Anti-HER2-Antibody Drug Conjugate (ADC)
Unresectable or Metastatic
Human epidermal growth factor receptor 2 (HER2)-low
DESTINY - Breast 04

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Parallel model, randomized at a 2:1 ratio

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Trastuzumab deruxtecan (DS-8201a)
Description: DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously
Arm group label: Trastuzumab deruxtecan

Other name: DS-8201a

Intervention type: Drug
Intervention name: Capecitabine
Description: Administered according to label, as one option for Physician's Choice (determined before randomization)
Arm group label: Physician's Choice

Intervention type: Drug
Intervention name: Eribulin
Description: Administered according to label, as one option for Physician's Choice (determined before randomization)
Arm group label: Physician's Choice

Intervention type: Drug
Intervention name: Gemcitabine
Description: Administered according to label, as one option for Physician's Choice (determined before randomization)
Arm group label: Physician's Choice

Intervention type: Drug
Intervention name: Paclitaxel
Description: Administered according to label, as one option for Physician's Choice (determined before randomization)
Arm group label: Physician's Choice

Intervention type: Drug
Intervention name: Nab-paclitaxel
Description: Administered according to label, as one option for Physician's Choice (determined before randomization)
Arm group label: Physician's Choice

Summary: This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: - Cannot be removed by an operation - Has spread to other parts of the body

Detailed description: This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer participants. The Sponsor proposes to define a new HER2-low population in this trial including tumors with IHC 1+ and IHC 2+/ISH- HER2 expression.

Criteria for 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 low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) 3. Is HR-positive or HR-negative 4. Has progressed on, and would no longer benefit from, endocrine therapy 5. Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting 6. Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines) - Has documented radiologic progression (during or after most recent treatment) - Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for: 1. assessment of HER2 status 2. assessment of post-treatment status - Has at least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors 1.1 - Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions - Male and female participants of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels) Exclusion Criteria: - Is ineligible for all options in the physician's choice arm - Has breast cancer ever assessed with high-HER2 expression - Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate - Has uncontrolled or significant cardiovascular disease - Has spinal cord compression or clinically active central nervous system metastases - Has 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 any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Ironwood Cancer & Research Centers - Chandler II

Address:
City: Chandler
Zip: 85224
Country: United States

Facility:
Name: Banner MD Anderson Cancer Center

Address:
City: Gilbert
Zip: 85234-2165
Country: United States

Facility:
Name: Cancer Treatment Centers of America at Western Regional Medical Center

Address:
City: Goodyear
Zip: 85338
Country: United States

Facility:
Name: UCLA School of Medicine

Address:
City: Los Angeles
Zip: 90095-1690
Country: United States

Facility:
Name: Stanford Cancer Institute

Address:
City: Palo Alto
Zip: 94305
Country: United States

Facility:
Name: Cancer Care Associates Medical Group, Inc. TORI

Address:
City: Redondo Beach
Zip: 90277
Country: United States

Facility:
Name: University of California at San Francisco (PARENT)

Address:
City: San Francisco
Zip: 94158
Country: United States

Facility:
Name: Eastern Connecticut Hematology/Oncology Assoc.

Address:
City: Norwich
Zip: 06360
Country: United States

Facility:
Name: Christiana Care Health Services, Inc.

Address:
City: Newark
Zip: 19713
Country: United States

Facility:
Name: Sylvester Comprehensive Cancer Center - Deerfield Beach

Address:
City: Boca Raton
Zip: 33426
Country: United States

Facility:
Name: Florida Cancer Specialists (South Region)

Address:
City: Fort Myers
Zip: 33916
Country: United States

Facility:
Name: Memorial Healthcare System MRH Cancer Center

Address:
City: Hollywood
Zip: 33021
Country: United States

Facility:
Name: Orlando Health, Inc.

Address:
City: Orlando
Zip: 32806
Country: United States

Facility:
Name: Moffitt Cancer Center -Tampa

Address:
City: Tampa
Zip: 33139
Country: United States

Facility:
Name: Cancer Treatment Centers of America-Georgia

Address:
City: Newnan
Zip: 30263
Country: United States

Facility:
Name: University of Chicago Medical Center

Address:
City: Chicago
Zip: 60637
Country: United States

Facility:
Name: Cancer Treatment Centers of America

Address:
City: Zion
Zip: 60099
Country: United States

Facility:
Name: Cancer Center of Kansas

Address:
City: Wichita
Zip: 67214
Country: United States

Facility:
Name: Touro Infirmary

Address:
City: New Orleans
Zip: 70115
Country: United States

Facility:
Name: Dana-Farber Cancer Institute

Address:
City: Boston
Zip: 02215
Country: United States

Facility:
Name: Henry Ford Hospital

Address:
City: Detroit
Zip: 48202
Country: United States

Facility:
Name: Saint Luke's Hospital of Kansas City

Address:
City: Kansas City
Zip: 64111
Country: United States

Facility:
Name: Saint Barnabas Medical Center

Address:
City: Livingston
Zip: 07039
Country: United States

Facility:
Name: New York University Medical Center

Address:
City: New York
Zip: 10016
Country: United States

Facility:
Name: Memorial Sloan Kettering Hospital

Address:
City: New York
Zip: 10065-6007
Country: United States

Facility:
Name: Weill Cornell Medicine Breast Center

Address:
City: New York
Zip: 10065
Country: United States

Facility:
Name: The Cleveland Clinic Foundation

Address:
City: Cleveland
Zip: 44195
Country: United States

Facility:
Name: Oregon Health & Science University

Address:
City: Portland
Zip: 97239
Country: United States

Facility:
Name: Allegheny General Hospital

Address:
City: Pittsburgh
Zip: 15212
Country: United States

Facility:
Name: University of Pittsburgh Medical Center Health System

Address:
City: Pittsburgh
Zip: 15219
Country: United States

Facility:
Name: St Francis Hospital

Address:
City: Greenville
Zip: 29601
Country: United States

Facility:
Name: Brig Center for Cancer Care and Survivorship

Address:
City: Knoxville
Zip: 37909
Country: United States

Facility:
Name: Baptist Cancer Center

Address:
City: Memphis
Zip: 38120
Country: United States

Facility:
Name: Tennessee Oncology - Skyline Satellite

Address:
City: Nashville
Zip: 37201
Country: United States

Facility:
Name: BloomTrials Clinical Research, LLC

Address:
City: Dallas
Zip: 75234
Country: United States

Facility:
Name: The Methodist Hospital Research Institute

Address:
City: Houston
Zip: 77030
Country: United States

Facility:
Name: University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics

Address:
City: Houston
Zip: 77030
Country: United States

Facility:
Name: Virginia Cancer Specialists

Address:
City: Fairfax
Zip: 22031
Country: United States

Facility:
Name: Medizinische Universität Innsbruck

Address:
City: Innsbruck
Zip: 6020
Country: Austria

Facility:
Name: Kepler Universitätsklinikum

Address:
City: Linz
Zip: 4020
Country: Austria

Facility:
Name: LKH - Universitätsklinikum der PMU Salzburg

Address:
City: Salzburg
Zip: 5020
Country: Austria

Facility:
Name: AKH - Medizinische Universität Wien (4305)

Address:
City: Vienna
Zip: 1090
Country: Austria

Facility:
Name: Klinikum Wels-Grieskirchen GmbH

Address:
City: Wels
Zip: 4600
Country: Austria

Facility:
Name: Institut Jules Bordet

Address:
City: Bruxelles
Zip: 1000
Country: Belgium

Facility:
Name: Universitair Ziekenhuis Brussel

Address:
City: Bruxelles
Zip: 1090
Country: Belgium

Facility:
Name: Cliniques Universitaires Saint-Luc

Address:
City: Bruxelles
Zip: 1200
Country: Belgium

Facility:
Name: UZ Leuven

Address:
City: Leuven
Zip: 3000
Country: Belgium

Facility:
Name: Grand Hôpital de Charleroi

Address:
City: Loverval
Zip: 6280
Country: Belgium

Facility:
Name: CHU UCL Namur

Address:
City: Namur
Zip: 5000
Country: Belgium

Facility:
Name: Centre Hospitalier Wallonie picarde - Site IMC

Address:
City: Tournai
Zip: 7500
Country: Belgium

Facility:
Name: Tom Baker Cancer Center

Address:
City: Calgary
Zip: T2N4N2
Country: Canada

Facility:
Name: Toronto Sunnybrook Hospital

Address:
City: Toronto
Zip: M4N 3M5
Country: Canada

Facility:
Name: McGill University - Dept. Oncology Clinical Research Program

Address:
City: Montréal
Zip: H2W 1S6
Country: Canada

Facility:
Name: Anhui Provincial Hospital

Address:
City: Hefei
Zip: 230001
Country: China

Facility:
Name: Cancer Hospital Chinese Academy of Medical Sciences

Address:
City: Beijing
Zip: 100021
Country: China

Facility:
Name: Chinese PLA General Hospital

Address:
City: Beijing
Zip: 100853
Country: China

Facility:
Name: Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA

Address:
City: Fuzhou
Zip: 350025
Country: China

Facility:
Name: Sun Yat-sen Memorial hospital, Sun Yat-sen University

Address:
City: Guangzhou
Zip: 510120
Country: China

Facility:
Name: Harbin Medical University Cancer Hospital

Address:
City: Harbin
Zip: 150081
Country: China

Facility:
Name: Hubei Cancer Hospital

Address:
City: Wuhan
Zip: 430079
Country: China

Facility:
Name: The Affiliated Drum Tower Hospital of Nanjing University

Address:
City: Nanjing
Zip: 210008
Country: China

Facility:
Name: The First Hospital of Jilin University

Address:
City: Chang chun
Zip: 130000
Country: China

Facility:
Name: Jilin Cancer Hospital

Address:
City: Chang chun
Zip: 130012
Country: China

Facility:
Name: Liaoning Cancer Hospital & Institute

Address:
City: Shenyang
Zip: 110042
Country: China

Facility:
Name: General Hospital of Ningxia Medical University

Address:
City: Yinchuan
Zip: 750004
Country: China

Facility:
Name: Linyi Cancer Hospital

Address:
City: Linyi
Zip: 276001
Country: China

Facility:
Name: Shanghai General Hospital

Address:
City: Shanghai
Zip: 200080
Country: China

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Zip: 20032
Country: China

Facility:
Name: West China Hospital, Sichuan University

Address:
City: Chengdu
Zip: 610041
Country: China

Facility:
Name: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

Address:
City: Hangzhou
Zip: 310016
Country: China

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Hangzhou
Zip: 310022
Country: China

Facility:
Name: Institut Paoli Calmettes

Address:
City: Marseille cedex 9
Zip: 13009
Country: France

Facility:
Name: Centre François Baclesse

Address:
City: Caen
Zip: 14076
Country: France

Facility:
Name: CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

Address:
City: Plérin
Zip: 22190
Country: France

Facility:
Name: CHU Brest - Hôpital Morvan

Address:
City: Brest Cedex
Zip: 29609
Country: France

Facility:
Name: Institut Bergonié

Address:
City: Bordeaux cedex
Zip: 33076
Country: France

Facility:
Name: Clinique Clementville

Address:
City: Montpellier
Zip: 34070
Country: France

Facility:
Name: Institut Régional du Cancer de Montpellier

Address:
City: Montpellier
Zip: 34298
Country: France

Facility:
Name: CRLCC Eugene Marquis

Address:
City: Rennes-cedex
Zip: 35042
Country: France

Facility:
Name: ICO - Site René Gauducheau

Address:
City: Saint-Herblain
Zip: 44805
Country: France

Facility:
Name: Centre Hospitalier Emile Roux

Address:
City: Le Puy-en-Velay
Zip: 43012
Country: France

Facility:
Name: ICO - Site Paul Papin

Address:
City: Angers Cedex 2
Zip: 49055
Country: France

Facility:
Name: Centre Hospitalier Valenciennes

Address:
City: Valenciennes
Zip: 59322
Country: France

Facility:
Name: Hôpital Saint-Louis - Paris

Address:
City: Paris Cedex 10
Zip: 75475
Country: France

Facility:
Name: Clinique Victor Hugo - Centre Jean Bernard

Address:
City: Le Mans Cedex 02
Zip: 72015
Country: France

Facility:
Name: Institut Sainte Catherine

Address:
City: Avignon Cedex 9
Zip: 84918
Country: France

Facility:
Name: Hôpital d'Instruction des Armees Begin*

Address:
City: Saint Mande
Zip: 94160
Country: France

Facility:
Name: Institut Gustave Roussy

Address:
City: Villejuif cedex
Zip: 94805
Country: France

Facility:
Name: Institut Curie - site de Paris

Address:
City: Paris
Zip: 75005
Country: France

Facility:
Name: Hopital Tenon

Address:
City: Paris
Zip: 75020
Country: France

Facility:
Name: Universitaetsklinikum Heidelberg

Address:
City: Heidelberg
Zip: 69120
Country: Germany

Facility:
Name: Klinikum der Universitaet Muenchen - Campus Grosshardern

Address:
City: Munich
Zip: 81377
Country: Germany

Facility:
Name: General Hospital of Athens "Alexandra"

Address:
City: Athens
Zip: 11528
Country: Greece

Facility:
Name: General Oncology Hospital of Kifissia " Agioi Anargyroi"

Address:
City: Athens
Zip: 14564
Country: Greece

Facility:
Name: Athens Medical Center

Address:
City: Athens
Zip: 15125
Country: Greece

Facility:
Name: University General Hospital of Heraklion

Address:
City: Heraklion
Zip: 71110
Country: Greece

Facility:
Name: University General Hospital of Larissa

Address:
City: Larissa
Zip: 41110
Country: Greece

Facility:
Name: Bioclinic Thessaloniki

Address:
City: Thessaloníki
Zip: 54622
Country: Greece

Facility:
Name: Euromedica General Clinic Thessaloniki

Address:
City: Thessaloníki
Zip: 54645
Country: Greece

Facility:
Name: General Hospital Papageorgiou

Address:
City: Thessaloníki
Zip: 56429
Country: Greece

Facility:
Name: Interbalkan Hospital of Thessaloniki

Address:
City: Thessaloníki
Zip: 57001
Country: Greece

Facility:
Name: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

Address:
City: Budapest
Zip: 1097
Country: Hungary

Facility:
Name: Orszagos Onkologiai Intezet

Address:
City: Budapest
Zip: 1122
Country: Hungary

Facility:
Name: Debreceni Egyetem

Address:
City: Debrecen
Zip: 4032
Country: Hungary

Facility:
Name: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

Address:
City: Gyula
Zip: 5700
Country: Hungary

Facility:
Name: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

Address:
City: Nyiregyhaza
Zip: 4400
Country: Hungary

Facility:
Name: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

Address:
City: Szolnok
Zip: 5004
Country: Hungary

Facility:
Name: Rambam Health Care Center

Address:
City: Haifa
Zip: 3109601
Country: Israel

Facility:
Name: Shaare Zedek Medical Center

Address:
City: Jerusalem
Zip: 9103102
Country: Israel

Facility:
Name: Hadassah University Hospital - Ein Kerem

Address:
City: Jerusalem
Zip: 9112001
Country: Israel

Facility:
Name: Rabin Medical Center-Beilinson Campus

Address:
City: Petah tikva
Zip: 49100
Country: Israel

Facility:
Name: Chaim Sheba Medical Center

Address:
City: Ramat Gan
Zip: 52363
Country: Israel

Facility:
Name: Kaplan Medical Center

Address:
City: Rechovot
Zip: 7610001
Country: Israel

Facility:
Name: Ziv Medical Center

Address:
City: Safed
Zip: 13100
Country: Israel

Facility:
Name: Tel Aviv Sourasky Medical Center

Address:
City: Tel Aviv
Zip: 6423906
Country: Israel

Facility:
Name: Azienda Ospedaliera Card. G. Panico

Address:
City: Tricase
Zip: 73039
Country: Italy

Facility:
Name: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

Address:
City: Monza
Zip: 20900
Country: Italy

Facility:
Name: Istituto Clinico Humanitas

Address:
City: Rozzano
Zip: 20089
Country: Italy

Facility:
Name: Ospedale Sacro Cuore Don Calabria

Address:
City: Negrar
Zip: 37024
Country: Italy

Facility:
Name: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

Address:
City: Bologna
Zip: 40138
Country: Italy

Facility:
Name: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

Address:
City: Brescia
Zip: 25100
Country: Italy

Facility:
Name: Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico

Address:
City: Catania
Zip: 95125
Country: Italy

Facility:
Name: Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario

Address:
City: Catanzaro
Zip: 88100
Country: Italy

Facility:
Name: IEO Istituto Europeo di Oncologia

Address:
City: Milano
Zip: 20141
Country: Italy

Facility:
Name: Istituto Nazionale Tumori Fondazione G. Pascale

Address:
City: Napoli
Zip: 80131
Country: Italy

Facility:
Name: Ospedale degli Infermi

Address:
City: Rimini
Zip: 47923
Country: Italy

Facility:
Name: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Address:
City: Roma
Zip: 00133
Country: Italy

Facility:
Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Address:
City: Roma
Zip: 00168
Country: Italy

Facility:
Name: Aichi Cancer Center Hospital

Address:
City: Nagoya
Zip: 464-8681
Country: Japan

Facility:
Name: National Cancer Center Hospital East

Address:
City: Kashiwa-shi
Zip: 277-8577
Country: Japan

Facility:
Name: NHO Shikoku Cancer Center

Address:
City: Matsuyama-shi
Zip: 791-0280
Country: Japan

Facility:
Name: NHO Kyushu Cancer Center

Address:
City: Fukuoka-shi
Zip: 811-1395
Country: Japan

Facility:
Name: Fukushima Medical University Hospital

Address:
City: Fukushima
Zip: 960-1295
Country: Japan

Facility:
Name: Hiroshima City Hiroshima Citizens Hospital

Address:
City: Hiroshima-shi
Zip: 730-8518
Country: Japan

Facility:
Name: NHO Hokkaido Cancer Center

Address:
City: Sapporo-shi
Zip: 003-0804
Country: Japan

Facility:
Name: Hyogo College of Medicine Hospital

Address:
City: Nishinomiya-shi
Zip: 663-8501
Country: Japan

Facility:
Name: Hakuaikai Sagara Hospital

Address:
City: Kagoshima
Zip: 892-0833
Country: Japan

Facility:
Name: Tokai University Hospital

Address:
City: Isehara
Zip: 259-1193
Country: Japan

Facility:
Name: Kanagawa Cancer Center

Address:
City: Yokohama
Zip: 241-8515
Country: Japan

Facility:
Name: NHO Osaka National Hospital

Address:
City: Osaka-shi
Zip: 540-0006
Country: Japan

Facility:
Name: Kindai University Hospital

Address:
City: Onohigashi
Zip: 589-8511
Country: Japan

Facility:
Name: Saitama Cancer Center

Address:
City: Kitaadachi-gun
Zip: 362-0806
Country: Japan

Facility:
Name: Shizuoka Cancer Center

Address:
City: Sunto-gun
Zip: 411-8777
Country: Japan

Facility:
Name: Cancer Institute Hospital of JFCR

Address:
City: Koto-Ku
Zip: 135-8550
Country: Japan

Facility:
Name: Toranomon Hospital

Address:
City: Minato-Ku
Zip: 105-8470
Country: Japan

Facility:
Name: Showa University Hospital

Address:
City: Shinagawa-Ku
Zip: 142-8666
Country: Japan

Facility:
Name: Chungbuk National University Hospital

Address:
City: Cheongju-si
Zip: 361-711
Country: Korea, Republic of

Facility:
Name: National Cancer Center

Address:
City: Goyang-si
Zip: 10408
Country: Korea, Republic of

Facility:
Name: Inha University Hospital

Address:
City: Incheon
Zip: 22332
Country: Korea, Republic of

Facility:
Name: Seoul National University Bundang Hospital

Address:
City: Seongnam-si
Zip: 13620
Country: Korea, Republic of

Facility:
Name: Ajou University Hospital

Address:
City: Suwon
Zip: 16499
Country: Korea, Republic of

Facility:
Name: Kyungpook National University Chilgok Hospital

Address:
City: Daegu
Zip: 41404
Country: Korea, Republic of

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Zip: 03080
Country: Korea, Republic of

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: The Catholic University of Korea, Seoul St. Mary's Hospital

Address:
City: Seoul
Zip: 06591
Country: Korea, Republic of

Facility:
Name: Severance Hospital, Yonsei University Health System

Address:
City: Seoul
Zip: 120-752
Country: Korea, Republic of

Facility:
Name: Hospital de Braga

Address:
City: Braga
Zip: 4710-243
Country: Portugal

Facility:
Name: Centro Hospitalar do Alto do Ave, EPE

Address:
City: Guimarães
Zip: 4835-044
Country: Portugal

Facility:
Name: Fundação Champalimaud

Address:
City: Lisboa
Zip: 1400-038
Country: Portugal

Facility:
Name: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

Address:
City: Lisboa
Zip: 1649-035
Country: Portugal

Facility:
Name: Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano)

Address:
City: Matosinhos
Zip: 4464-509
Country: Portugal

Facility:
Name: Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António

Address:
City: Porto
Zip: 4099-001
Country: Portugal

Facility:
Name: Instituto Português de Oncologia do Porto Francisco Gentil, EPE

Address:
City: Porto
Zip: 4200-072
Country: Portugal

Facility:
Name: Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião

Address:
City: Santa Maria Da Feira
Zip: 4520-211
Country: Portugal

Facility:
Name: Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E

Address:
City: Vila Nova De Gaia
Zip: 4434-502
Country: Portugal

Facility:
Name: Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE

Address:
City: Vila Real
Zip: 5000-508
Country: Portugal

Facility:
Name: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

Address:
City: Moscow
Zip: 115478
Country: Russian Federation

Facility:
Name: SBIH of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Departement

Address:
City: Moscow
Zip: 143423
Country: Russian Federation

Facility:
Name: SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"

Address:
City: Yaroslavl
Zip: 150054
Country: Russian Federation

Facility:
Name: ICO l'Hospitalet - Hospital Duran i Reynals

Address:
City: L'Hospitalet De Llobregat
Zip: 08908
Country: Spain

Facility:
Name: Hospital Universitario Donostia

Address:
City: San Sebastián
Zip: 20014
Country: Spain

Facility:
Name: Complejo Hospitalario Universitario A Coruña

Address:
City: A Coruña
Zip: 15006
Country: Spain

Facility:
Name: Hospital Universitario de Canarias

Address:
City: San Cristobal de la Laguna
Zip: 38320
Country: Spain

Facility:
Name: Hospital de Basurto

Address:
City: Bilbao
Zip: 48013
Country: Spain

Facility:
Name: Hospital del Mar

Address:
City: Barcelona
Zip: 08003
Country: Spain

Facility:
Name: Hospital Quironsalud Barcelona

Address:
City: Barcelona
Zip: 08023
Country: Spain

Facility:
Name: Hospital Universitari Vall d'Hebron

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: Hospital Clinic de Barcelona

Address:
City: Barcelona
Zip: 08036
Country: Spain

Facility:
Name: MD Anderson Cancer Centre

Address:
City: Madrid
Zip: 28033
Country: Spain

Facility:
Name: Hospital Ruber Internacional

Address:
City: Madrid
Zip: 28034
Country: Spain

Facility:
Name: Hospital Universitario Ramon y Cajal

Address:
City: Madrid
Zip: 28034
Country: Spain

Facility:
Name: Hospital Universitario Clinico San Carlos

Address:
City: Madrid
Zip: 28040
Country: Spain

Facility:
Name: Hospital Clinico Universitario Virgen de la Victoria

Address:
City: Málaga
Zip: 29010
Country: Spain

Facility:
Name: Hospital Universitario Virgen Macarena

Address:
City: Sevilla
Zip: 41009
Country: Spain

Facility:
Name: Hospital Universitario Virgen del Rocio

Address:
City: Sevilla
Zip: 41013
Country: Spain

Facility:
Name: Instituto Valenciano de Oncologia IVO

Address:
City: Valencia
Zip: 46009
Country: Spain

Facility:
Name: Hospital General Universitario de Valencia

Address:
City: Valencia
Zip: 46014
Country: Spain

Facility:
Name: Karolinska universitetssjukhuset - Solna

Address:
City: Solna
Zip: 17176
Country: Sweden

Facility:
Name: Länssjukhuset Sundsvall-Härnösand

Address:
City: Sundsvall
Zip: 85186
Country: Sweden

Facility:
Name: Akademiska Sjukhuset

Address:
City: Uppsala
Zip: 75185
Country: Sweden

Facility:
Name: Hirslanden Medical Center

Address:
City: Aarau
Zip: 5000
Country: Switzerland

Facility:
Name: Universitaetsspital Basel

Address:
City: Basel
Zip: 4031
Country: Switzerland

Facility:
Name: Kantonsspital Graubuenden

Address:
City: Chur
Zip: 7000
Country: Switzerland

Facility:
Name: Centre Hospitalier Universitaire Vaudois

Address:
City: Lausanne
Zip: 1011
Country: Switzerland

Facility:
Name: Kantonsspital St. Gallen

Address:
City: Saint Gallen
Zip: 9007
Country: Switzerland

Facility:
Name: Kantonsspital Winterthur

Address:
City: Winterthur
Zip: 8401
Country: Switzerland

Facility:
Name: Universitaetsspital Zuerich

Address:
City: Zürich
Zip: 8091
Country: Switzerland

Facility:
Name: Kaohsiung Medical University Chung-Ho Memorial Hospital

Address:
City: Kaohsiung
Zip: 807
Country: Taiwan

Facility:
Name: National Cheng Kung University Hospital

Address:
City: Tainan
Zip: 704
Country: Taiwan

Facility:
Name: National Taiwan University Hospital

Address:
City: Taipei
Zip: 100
Country: Taiwan

Facility:
Name: Royal Cornwall Hospital

Address:
City: Truro
Zip: TR1 3LJ
Country: United Kingdom

Facility:
Name: Queen Mary University of London

Address:
City: London
Zip: EC1M 6BQ
Country: United Kingdom

Facility:
Name: University College London Hospitals

Address:
City: London
Zip: NW1 2PG
Country: United Kingdom

Facility:
Name: Royal Free Hospital

Address:
City: London
Zip: NW3 2QG
Country: United Kingdom

Facility:
Name: Western General Hospital

Address:
City: Edinburgh
Zip: EH4 2XU
Country: United Kingdom

Facility:
Name: Nottingham University Hospitals City Campus

Address:
City: Nottingham
Zip: NG5 1PB
Country: United Kingdom

Facility:
Name: Royal Surrey County Hospital

Address:
City: Guildford
Zip: GU2 7XX
Country: United Kingdom

Start date: December 27, 2018

Completion date: October 1, 2025

Lead sponsor:
Agency: Daiichi Sankyo
Agency class: Industry

Collaborator:
Agency: Daiichi Sankyo Co., Ltd.
Agency class: Industry

Collaborator:
Agency: AstraZeneca
Agency class: Industry

Source: Daiichi Sankyo

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT03734029