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]

April 2, 2024 updated by: Daiichi Sankyo

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

524

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Tweed Heads, New South Wales, Australia, 2485
        • The Tweed Hospital
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Frankston, Victoria, Australia, 3199
        • Peninsula and South Eastern Haematology & Oncology Group
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • St John of God Subiaco Hospital
  • Belgium
      • Bruxelles, Belgium, 1000
        • Institut Jules-Bordet
      • Bruxelles, Belgium, 1090
        • Universitair Ziekenhuis Brussel
      • Edegem, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen
      • Gent, Belgium, 9000
        • AZ Sint-Lucas - Campus Sint-Lucas
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven
      • Namur, Belgium, 5000
        • CHU UCL Namur site de Sainte Elisabeth
  • Brazil
      • Rio De Janeiro, Brazil, 22793-080
        • Instituto Americas
      • São Paulo, Brazil, 01509-900
        • A. C. Camargo Cancer Center
    • Bahia
      • Salvador, Bahia, Brazil, 40170-110
        • Nob - Nucleo de Oncologia Da Bahia
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao
    • Santa Catarina
      • Itajaí, Santa Catarina, Brazil, 88301-220
        • Catarina Pesquisa Clinica
    • Sao Paulo
      • Santo André, Sao Paulo, Brazil, 09060-650
        • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
      • São Paulo, Sao Paulo, Brazil, 01246-000
        • ICESP - Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira
      • São Paulo, Sao Paulo, Brazil, 01317-001
        • Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda.
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Hospital
    • Quebec
      • Montréal, Quebec, Canada, H3T 1M5
        • St. Mary's Hospital
  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Beijing Hospital
      • Beijing, Beijing, China, 100021
        • Cancer hospital Chinese academy of medical sciences
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital, Sun Yat-Sen University
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University, Cancer Center
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Harbin Medical University Cancer Hospital
    • Jilin
      • Chang chun, Jilin, China, 130021
        • The First Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • LiaoNing Cancer Hospital & Institute
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Tianjin Medical University Cancer Institute & Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310000
        • Sir Run Run Shaw Hospital Xiasha Branch, Zhejiang University, School of Medicine
  • France
      • Paris, France, 75020
        • Hôpital Tenon
      • Paris, France, 75010
        • Hôpital Saint-Louis
      • Paris, France, 75005
        • Institut Curie - site de Paris
    • Bas Rhin
      • Strasbourg Cedex, Bas Rhin, France, 67000
        • Centre Paul Strauss
    • Bouches-du-Rhone
      • Marseille Cedex 20, Bouches-du-Rhone, France, 13915
        • Hôpital Nord - CHU Marseille
    • Calvados
      • Caen Cedex 05, Calvados, France, 14076
        • Centre François Baclesse
    • Cedex 02, Sarthe
      • Le Mans, Cedex 02, Sarthe, France, 72015
        • Clinique Victor Hugo - Centre Jean Bernard
    • Cotes d'Armor
      • Plérin, Cotes d'Armor, France, 22190
        • CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
    • Côte-d'Or
      • Dijon cedex, Côte-d'Or, France, 21079
        • Centre Georges François Leclerc
    • Doubs
      • Besançon, Doubs, France, 25030
        • CHRU Jean Minjoz
    • Gironde
      • Bordeaux cedex, Gironde, France, 33076
        • Institut Bergonie
    • Hauts De Seine
      • Saint-Cloud, Hauts De Seine, France, 92110
        • Centre René Huguenin
    • Herault
      • Montpellier, Herault, France, 34298
        • ICM Val d'Aurelle
    • Ille Et Vilaine
      • Rennes cedex, Ille Et Vilaine, France, 35042
        • CRLCC Eugene Marquis
    • Loire Atlantique
      • Saint-Herblain, Loire Atlantique, France, 44805
        • ICO - Site René Gauducheau
    • Maine Et Loire
      • Angers Cedex 2, Maine Et Loire, France, 49055
        • ICO - Site Paul Papin
    • Nord
      • Valenciennes, Nord, France, 59300
        • Centre de cancerologie les Dentellieres
    • Rhone
      • Lyon Cedex 08, Rhone, France, 69373
        • Centre Leon Berard
      • Pierre Benite Cedex, Rhone, France, 69495
        • Centre Hospitalier Lyon Sud
    • Vaculuse
      • Avignon Cedex 9, Vaculuse, France, 84918
        • Institut Sainte Catherine
    • Val De Marne
      • Saint-Mandé, Val De Marne, France, 94160
        • Hôpital d'Instruction des Armées Bégin
      • Villejuif cedex, Val De Marne, France, 94805
        • Institut Gustave Roussy
  • Germany
    • Bayern
      • Erlangen, Bayern, Germany, 91-54
        • Universitaetsklinikum Erlangen
      • Muenchen, Bayern, Germany, 81675
        • Klinikum rechts der Isar der TU Muenchen
      • Muenchen, Bayern, Germany, 80637
        • Rotkreuzklinikum Muenchen gGmbH
    • Nordrhein Westfalen
      • Düsseldorf, Nordrhein Westfalen, Germany, 40225
        • Universitaetsklinikum Duesseldorf AoeR
      • Troisdorf, Nordrhein Westfalen, Germany, 53840
        • Haematologisch-Onkologische Schwerpunktpraxis
    • Rheinland Pfalz
      • Bottrop, Rheinland Pfalz, Germany, 46236
        • Marienhospital Bottrop gGmbH
    • Schleswig Holstein
      • Luebeck, Schleswig Holstein, Germany, 23538
        • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
  • Hong Kong
      • Hong Kong, Hong Kong, 00000
        • The Chinese
      • Shatin, Hong Kong, 00000
        • The University of Hong Kong
  • Italy
      • Bergamo, Italy, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
      • Bologna, Italy, 40138
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
      • Genova, Italy, 16132
        • Istituto Nazionale per la Ricerca sul Cancro di Genova
      • Lecco, Italy, 23900
        • Azienda Ospealiera della Provincia di Lecco
      • Messina, Italy, 98158
        • Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
      • Milano, Italy, 20132
        • Ospedale San Raffaele
      • Milano, Italy, 20141
        • IEO Istituto Europeo di Oncologia
      • Modena, Italy, 41124
        • A.O.U. Policlinico di Modena
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori Fondazione G. Pascale
      • Parma, Italy, 43100
        • Azienda Ospedaliero Universitaria di Parma
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
      • Torino, Italy, 10126
        • Azienda Ospedaliera Citta della Salute e della Scienza di Torino
    • Ferrara
      • Cona, Ferrara, Italy, 44124
        • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
    • Milano
      • Monza, Milano, Italy, 20900
        • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), U.O Oncologia Medica
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • IRCCS Centro di Riferimento Oncologico
  • Japan
      • Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital
      • Ehime, Japan, 791-0280
        • NHO Shikoku Cancer Center
      • Fukuoka, Japan, 811-1395
        • NHO Kyushu Cancer Center
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hiroshima Citizens Hospital
      • Hokkaido, Japan, 003-0804
        • NHO Hokkaido Cancer Center
      • Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
      • Osaka, Japan, 540-0006
        • NHO Osaka National Hospital
      • Saitama, Japan, 362-0806
        • Saitama Cancer Center
      • Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR
      • Tokyo, Japan, 142-8666
        • Showa University Hospital
    • Tokyo-To
      • Shinjuku-Ku, Tokyo-To, Japan, 162-8655
        • Center Hospital of the National Center for Global Health and Medicine
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
  • Spain
      • Badajoz, Spain, 6007
        • Hospital Infanta Cristina
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall D'Hebron
      • Barcelona, Spain, 8023
        • IOB-Institute of Oncology
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28040
        • Hospital Universitario Clínico San Carlos
      • Madrid, Spain, 28033
        • MD Anderson Cancer Centre
      • Málaga, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen Del Rocio
    • Barcelona
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08908
        • ICO l'Hospitalet - Hospital Duran i Reynals
    • La Coruña
      • A Coruña, La Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña
      • Santiago De Compostela, La Coruña, Spain, 15706
        • Complejo Hospitalario Universitario De Santiago
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
    • Sevill
      • Sevilla, Sevill, Spain, 41009
        • Hospital Universitario Virgen Macarena
    • Tenerife
      • San Cristobal de la Laguna, Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 112
        • Koo Foundation, Sun Yat-Sen Cancer Center
  • United Kingdom
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital (Wonford)
    • Grampian Region
      • Aberdeen, Grampian Region, United Kingdom, AB25 2ZB
        • Aberdeen Royal Infirmary
    • Greater London
      • London, Greater London, United Kingdom, EC1M 6BQ
        • Queen Mary University of London
      • London, Greater London, United Kingdom, NW1 2PG
        • University College London Hospitals
      • London, Greater London, United Kingdom, SE1 9RY
        • Guy's Hospital
      • London, Greater London, United Kingdom, W1G 6AD
        • Sarah Cannon Research Institute UK
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • The Christie Hospital
    • Lothian Region
      • Edinburgh, Lothian Region, United Kingdom, EH4 2XU
        • Western General Hospital
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Nottingham University Hospitals City Campus
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Hematology Oncology
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
      • San Francisco, California, United States, 94115
        • University of California San Francisco
      • Whittier, California, United States, 90603
        • Innovative Clinical Research Institute
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Cancer Institute
    • Florida
      • Fort Myers, Florida, United States, 33916
        • Florida Cancer Specialists-Broadway
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists NORTH
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Piedmont Cancer Institute, PC
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Health System
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New York
      • East Setauket, New York, United States, 11733
        • North Shore Hematology Oncology Associates, PC
      • Rochester, New York, United States, 14642
        • University of Rochester
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States, 44106
        • Seidman Cancer Center
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
      • Kettering, Ohio, United States, 45409
        • Dayton Physicians, LLC
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Womens Hospital of UPMC
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Tennessee Oncology- St Thomas Location
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Breast Center at One Hundred Oaks
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • Houston, Texas, United States, 77090
        • Millennium Oncology
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital / Houston Methodist Cancer Center
      • Tyler, Texas, United States, 75708
        • The University of Texas Health Science Center at Tyler
    • Washington
      • Auburn, Washington, United States, 98001
        • MultiCare Health System Institute for Research and Innovation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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.

    1. Participants with clinically inactive brain metastases may be included in the study.
    2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trastuzumab deruxtecan (T-DXd)
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).
Drug: Trastuzumab deruxtecan (T-DXd)
T-DXd is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously.
Other Names:
  • DS-8201a
Active Comparator: 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-DM1 in accordance with the approved label.
Drug: Ado-trastuzumab emtansine (T-DM1)
The treatment will be in accordance with the approved label.
Other Names:
  • T-DM1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
Time Frame: Up to 33 months (data cut-off)
Progression-free survival (PFS) by BICR was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
Up to 33 months (data cut-off)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
Time Frame: Up to 33 months (data cut-off)
Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.
Up to 33 months (data cut-off)
Percentage of Participants With Objective Response Rate (ORR) Based on BICR and Investigator Assessment in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
Time Frame: Up to 33 months (data cut-off)
The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by BICR and investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR is reported.
Up to 33 months (data cut-off)
Duration of Response (DoR) Based on BICR and Investigator Assessment in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
Time Frame: Up to 33 months (data cut-off)
Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR in participants with confirmed CR/PR based on BICR and investigator assessment is reported.
Up to 33 months (data cut-off)
Progression-Free Survival (PFS) Based on Investigator Assessment in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
Time Frame: Up to 33 months (data cut-off)
Progression-free survival (PFS) by investigator assessment was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
Up to 33 months (data cut-off)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo

Collaborators

AstraZeneca
Daiichi Sankyo Co., Ltd.

Investigators

  • Study Director: Global Team Leader, Daiichi Sankyo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2018

Primary Completion (Actual)

May 21, 2021

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 13, 2018

First Submitted That Met QC Criteria

May 7, 2018

First Posted (Actual)

May 18, 2018

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS8201-A-U302
  • 2018-000222-61 (EudraCT Number)
  • 183976 (Registry Identifier: JAPIC CTI)
  • DESTINY-B03 (Other Identifier: Daiichi Sankyo and AstraZeneca)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD Sharing Time Frame

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD Sharing Access Criteria

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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