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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]

Primary Purpose

Breast Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Trastuzumab deruxtecan (T-DXd)
Ado-trastuzumab emtansine (T-DM1)
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

Arm Type

Experimental

Active Comparator

Arm Label

Trastuzumab deruxtecan (T-DXd)

Ado-trastuzumab emtansine (T-DM1)

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Overall Survival (OS) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
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.
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
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.
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
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.
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
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.

Full Information

First Posted
April 13, 2018
Last Updated
February 7, 2023
Sponsor
Daiichi Sankyo, Inc.
Collaborators
Daiichi Sankyo Co., Ltd., AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT03529110
Brief Title
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]
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 9, 2018 (Actual)
Primary Completion Date
May 21, 2021 (Actual)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.
Collaborators
Daiichi Sankyo Co., Ltd., AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Metastatic breast cancer, DS-8201a, DESTINY - Breast 03

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
524 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trastuzumab deruxtecan (T-DXd)
Arm Type
Experimental
Arm Description
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).
Arm Title
Ado-trastuzumab emtansine (T-DM1)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab deruxtecan (T-DXd)
Other Intervention Name(s)
DS-8201a
Intervention Description
T-DXd is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Ado-trastuzumab emtansine (T-DM1)
Other Intervention Name(s)
T-DM1
Intervention Description
The treatment will be in accordance with the approved label.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Up to 33 months (data cut-off)
Secondary Outcome Measure Information:
Title
Overall Survival (OS) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
Description
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.
Time Frame
Up to 33 months (data cut-off)
Title
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
Description
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.
Time Frame
Up to 33 months (data cut-off)
Title
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
Description
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.
Time Frame
Up to 33 months (data cut-off)
Title
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
Description
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.
Time Frame
Up to 33 months (data cut-off)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Team Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Hematology Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Innovative Clinical Research Institute
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Washington Cancer Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Florida Cancer Specialists-Broadway
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Florida Cancer Specialists NORTH
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Piedmont Cancer Institute, PC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Loyola University Health System
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
North Shore Hematology Oncology Associates, PC
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Seidman Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Dayton Physicians, LLC
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Magee-Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Tennessee Oncology- St Thomas Location
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Vanderbilt Breast Center at One Hundred Oaks
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8857
Country
United States
Facility Name
Houston Methodist Hospital / Houston Methodist Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Millennium Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
The University of Texas Health Science Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Name
MultiCare Health System Institute for Research and Innovation
City
Auburn
State/Province
Washington
ZIP/Postal Code
98001
Country
United States
Facility Name
The Tweed Hospital
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Peninsula and South Eastern Haematology & Oncology Group
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Peter MacCallum Cancer
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
St John of God Subiaco Hospital
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Institut Jules-Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel
City
Bruxelles
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
AZ Sint-Lucas - Campus Sint-Lucas
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU UCL Namur site de Sainte Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
NOB - Nucleo de Oncologia da Bahia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40170-110
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceição
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Clínica de Neoplasias Litoral Ltda.
City
Itajaí
State/Province
Santa Catarina
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
City
Santo André
State/Province
Sao Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
ICESP - Instituto do Cancer do Estado de São Paulo Octavio Frias de Oliveira
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda.
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01317-001
Country
Brazil
Facility Name
COI - Clínicas Oncológicas Integradas
City
Rio De Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
A. C. Camargo Cancer Center
City
São Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Toronto Sunnybrook Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Mary's Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1M5
Country
Canada
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Sun Yat-sen University, Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
The First Hospital of Jilin University
City
Chang chun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Sir Run Run Shaw Hospital Xiasha Branch, Zhejiang University, School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Centre Paul Strauss
City
Strasbourg Cedex
State/Province
Bas Rhin
ZIP/Postal Code
67000
Country
France
Facility Name
Hôpital Nord - CHU Marseille
City
Marseille Cedex 20
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13915
Country
France
Facility Name
Centre François Baclesse
City
Caen Cedex 05
State/Province
Calvados
ZIP/Postal Code
14076
Country
France
Facility Name
Clinique Victor Hugo - Centre Jean Bernard
City
Le Mans
State/Province
Cedex 02, Sarthe
ZIP/Postal Code
72015
Country
France
Facility Name
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
City
Plérin
State/Province
Cotes d'Armor
ZIP/Postal Code
22190
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon cedex
State/Province
Côte-d'Or
ZIP/Postal Code
21079
Country
France
Facility Name
CHRU Jean Minjoz
City
Besançon
State/Province
Doubs
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonié
City
Bordeaux cedex
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Facility Name
Centre René Huguenin
City
Saint-Cloud
State/Province
Hauts De Seine
ZIP/Postal Code
92110
Country
France
Facility Name
ICM Val d'Aurelle
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34298
Country
France
Facility Name
CRLCC Eugene Marquis
City
Rennes cedex
State/Province
Ille Et Vilaine
ZIP/Postal Code
35042
Country
France
Facility Name
Institut de cancérologie de l'ouest, site René Gauducheau
City
Saint-Herblain
State/Province
Loire Atlantique
ZIP/Postal Code
44805
Country
France
Facility Name
ICO - Site Paul Papin
City
Angers Cedex 2
State/Province
Maine Et Loire
ZIP/Postal Code
49055
Country
France
Facility Name
Centre de cancerologie les Dentellieres
City
Valenciennes
State/Province
Nord
ZIP/Postal Code
59300
Country
France
Facility Name
Centre Leon Berard
City
Lyon Cedex 08
State/Province
Rhone
ZIP/Postal Code
69373
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite Cedex
State/Province
Rhone
ZIP/Postal Code
69495
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon Cedex 9
State/Province
Vaculuse
ZIP/Postal Code
84918
Country
France
Facility Name
Hôpital d'Instruction des Armees Begin*
City
Saint-Mandé
State/Province
Val De Marne
ZIP/Postal Code
94160
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif cedex
State/Province
Val De Marne
ZIP/Postal Code
94805
Country
France
Facility Name
Institut Curie - site de Paris
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Universitaetsklinikum Erlangen
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91-54
Country
Germany
Facility Name
Rotkreuzklinikum Muenchen gGmbH
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80637
Country
Germany
Facility Name
Klinikum rechts der Isar der TU Muenchen
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsklinikum Duesseldorf AoeR
City
Düsseldorf
State/Province
Nordrhein Westfalen
ZIP/Postal Code
40225
Country
Germany
Facility Name
Haematologisch-Onkologische Schwerpunktpraxis
City
Troisdorf
State/Province
Nordrhein Westfalen
ZIP/Postal Code
53840
Country
Germany
Facility Name
Marienhospital Bottrop gGmbH
City
Bottrop
State/Province
Rheinland Pfalz
ZIP/Postal Code
46236
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
City
Luebeck
State/Province
Schleswig Holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
Queen Mary Hospital
City
Hong Kong
ZIP/Postal Code
00000
Country
Hong Kong
Facility Name
Chinese University of Hong Kong
City
Shatin
ZIP/Postal Code
00000
Country
Hong Kong
Facility Name
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
City
Cona
State/Province
Ferrara
ZIP/Postal Code
44124
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), U.O Oncologia Medica
City
Monza
State/Province
Milano
ZIP/Postal Code
20900
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
IRCCS Centro di Riferimento Oncologico
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Istituto Nazionale per la Ricerca sul Cancro di Genova
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Azienda Ospealiera della Provincia di Lecco
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
City
Messina
ZIP/Postal Code
98158
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
IEO Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
A.O.U. Policlinico di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Istituto Nazionale Tumori Fondazione G. Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Shinjuku-Ku
State/Province
Tokyo-To
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Aichi Cancer Center Hospital
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
NHO Shikoku Cancer Center
City
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
NHO Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospital
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
NHO Hokkaido Cancer Center
City
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Niigata Cancer Center
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
NHO Osaka National Hospital
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Saitama Cancer Center
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Showa University Hospital
City
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
ICO l'Hospitalet - Hospital Duran i Reynals
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruña
City
A Coruña
State/Province
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago
City
Santiago De Compostela
State/Province
La Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
State/Province
Sevill
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
San Cristobal de la Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital Infanta Cristina
City
Badajoz
ZIP/Postal Code
6007
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
IOB-Institute of Oncology
City
Barcelona
ZIP/Postal Code
8023
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
MD Anderson Cancer Centre
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Koo Foundation, Sun Yat-Sen Cancer Center
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Royal Devon and Exeter Hospital (Wonford)
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Grampian Region
ZIP/Postal Code
AB25 2ZB
Country
United Kingdom
Facility Name
Queen Mary University of London
City
London
State/Province
Greater London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
University College London Hospitals
City
London
State/Province
Greater London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
SE1 9RY
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute UK
City
London
State/Province
Greater London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
State/Province
Lothian Region
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Nottingham University Hospitals City Campus
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/daiichi-sankyo/
Citations:
PubMed Identifier
35964548
Citation
Rugo HS, Bianchini G, Cortes J, Henning JW, Untch M. Optimizing treatment management of trastuzumab deruxtecan in clinical practice of breast cancer. ESMO Open. 2022 Aug;7(4):100553. doi: 10.1016/j.esmoop.2022.100553. Epub 2022 Aug 11.
Results Reference
derived
PubMed Identifier
35320644
Citation
Cortes J, Kim SB, Chung WP, Im SA, Park YH, Hegg R, Kim MH, Tseng LM, Petry V, Chung CF, Iwata H, Hamilton E, Curigliano G, Xu B, Huang CS, Kim JH, Chiu JWY, Pedrini JL, Lee C, Liu Y, Cathcart J, Bako E, Verma S, Hurvitz SA; DESTINY-Breast03 Trial Investigators. Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer. N Engl J Med. 2022 Mar 24;386(12):1143-1154. doi: 10.1056/NEJMoa2115022.
Results Reference
derived

Learn more about this trial

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]

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