Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03523585
Registration number
NCT03523585
Ethics application status
Date submitted
13/04/2018
Date registered
14/05/2018
Titles & IDs
Public title
DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
Query!
Scientific title
A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1
Query!
Secondary ID [1]
0
0
2018-000221-31
Query!
Secondary ID [2]
0
0
DS8201-A-U301
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Breast
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Trastuzumab deruxtecan
Treatment: Drugs - Capecitabine
Treatment: Drugs - Lapatinib
Treatment: Drugs - Trastuzumab
Experimental: Trastuzumab deruxtecan (DS-8201a) - HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to treatment with DS-8201a
Active comparator: Trastuzumab+capecitabine - HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Trastuzumab/capecitabine
Active comparator: Lapatinib+capecitabine - HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Lapatinib/capecitabine
Treatment: Drugs: Trastuzumab deruxtecan
DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as intravenous (IV) dose
Treatment: Drugs: Capecitabine
Investigator's choice Standard of Care when combined with trastuzumab or lapatinib
Treatment: Drugs: Lapatinib
Investigator's choice Standard of Care when combined with capecitabine
Treatment: Drugs: Trastuzumab
Investigator's choice Standard of Care when combined with capecitabine
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
Query!
Assessment method [1]
0
0
Progression-free survival (PFS) by BICR was defined as the time from the date of randomization 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.
Query!
Timepoint [1]
0
0
Baseline up to 46 months postdose
Query!
Secondary outcome [1]
0
0
Overall Survival (OS) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
Query!
Assessment method [1]
0
0
Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there is no death reported for a subject before the data cutoff for OS analysis, OS will be censored at the last contact date at which the subject is known to be alive.
Query!
Timepoint [1]
0
0
Baseline up to 46 months postdose
Query!
Secondary outcome [2]
0
0
Percentage of Participants With Objective Response Rate (ORR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
Query!
Assessment method [2]
0
0
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 based on BICR and Investigator Assessment is reported.
Query!
Timepoint [2]
0
0
Baseline up to 46 months postdose
Query!
Secondary outcome [3]
0
0
Duration of Response (DoR) Based on BICR in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline up to 46 months postdose
Query!
Secondary outcome [4]
0
0
Progression-Free Survival (PFS) Based on Investigator Assessment in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
Query!
Assessment method [4]
0
0
Progression-free survival (PFS) by investigator assessment was defined as the time from the date of randomization 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.
Query!
Timepoint [4]
0
0
Up to 46 months
Query!
Eligibility
Key inclusion criteria
* Is the age of majority in their country
* Has pathologically documented breast cancer that:
1. is unresectable or metastatic
2. has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
3. was previously treated with ado-trastuzumab emtansine (T-DM1)
* Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy)
* Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.
* Male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least:
1. 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males)
2. 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)
3. 7 months after the last dose of trastuzumab/capecitabine
* Has adequate hematopoietic, renal and hepatic functions
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Has previously participated in an antibody drug conjugate study sponsored by Daiichi Sankyo. Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy
* Has had prior treatment with capecitabine
* Has uncontrolled or significant cardiovascular disease
* Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
* Has active central nervous system (CNS) metastases
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/08/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/05/2025
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
608
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
St Vincent's Hospital Sydney - Darlinghurst
Query!
Recruitment hospital [2]
0
0
Liverpool Hospital - Liverpool
Query!
Recruitment hospital [3]
0
0
Macquarie University Hospital - Sydney
Query!
Recruitment hospital [4]
0
0
The Tweed Hospital - Tweed Heads
Query!
Recruitment hospital [5]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment hospital [6]
0
0
Ashford Cancer Centre Research - Kurralta Park
Query!
Recruitment hospital [7]
0
0
Box Hill Hospital - Box Hill
Query!
Recruitment hospital [8]
0
0
Frankston Hospital - Frankston
Query!
Recruitment hospital [9]
0
0
Peninsula and South Eastern Haematology & Oncology Group - Frankston
Query!
Recruitment hospital [10]
0
0
Austin Health - Heidelberg
Query!
Recruitment hospital [11]
0
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment hospital [12]
0
0
Sunshine Hospital - Saint Albans
Query!
Recruitment hospital [13]
0
0
South West Oncology - Warrnambool
Query!
Recruitment hospital [14]
0
0
Ballarat Oncology & Haematology Service - Wendouree
Query!
Recruitment hospital [15]
0
0
St John of God Subiaco Hospital - Subiaco
Query!
Recruitment hospital [16]
0
0
Calvary North Adelaide Hospital - Bruce
Query!
Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [3]
0
0
2109 - Sydney
Query!
Recruitment postcode(s) [4]
0
0
2485 - Tweed Heads
Query!
Recruitment postcode(s) [5]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [6]
0
0
5037 - Kurralta Park
Query!
Recruitment postcode(s) [7]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [8]
0
0
3199 - Frankston
Query!
Recruitment postcode(s) [9]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [10]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [11]
0
0
3021 - Saint Albans
Query!
Recruitment postcode(s) [12]
0
0
3280 - Warrnambool
Query!
Recruitment postcode(s) [13]
0
0
3355 - Wendouree
Query!
Recruitment postcode(s) [14]
0
0
6008 - Subiaco
Query!
Recruitment postcode(s) [15]
0
0
2614 - Bruce
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
District of Columbia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Hawaii
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maine
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Massachusetts
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Michigan
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Missouri
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New York
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Ohio
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Pennsylvania
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Tennessee
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Texas
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Utah
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Virginia
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Washington
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Bruxelles
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Gent
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Kortrijk
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Leuven
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Namur
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Bahia
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
Ceará
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Minas Gerais
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
Rio Grande Do Sul
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
Santa Catarina
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
Sao Paulo
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
Rio De Janeiro
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
São Paulo
Query!
Country [37]
0
0
Czechia
Query!
State/province [37]
0
0
Brno
Query!
Country [38]
0
0
Czechia
Query!
State/province [38]
0
0
Olomouc
Query!
Country [39]
0
0
Czechia
Query!
State/province [39]
0
0
Prague 5
Query!
Country [40]
0
0
Czechia
Query!
State/province [40]
0
0
Praha
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Bouches-du-Rhône
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Calvados
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Cotes d'Armor
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Côte-d'Or
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Doubs
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Finistere
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Hauts De Seine
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Herault
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Ille Et Vilaine
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Nord
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Paris
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Pyrenees Atlantiques
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Rhone
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Sarthe
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Seine Maritime
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Vaculuse
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Val De Marne
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Montpellier
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Bayern
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Rheinland Pfalz
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Schleswig Holstein
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Berlin
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Düsseldorf
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Erlangen
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Koeln
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Leipzig
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Munich
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Müenster
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Troisdorf
Query!
Country [70]
0
0
Greece
Query!
State/province [70]
0
0
Athens
Query!
Country [71]
0
0
Greece
Query!
State/province [71]
0
0
Heraklion
Query!
Country [72]
0
0
Greece
Query!
State/province [72]
0
0
Thessaloníki
Query!
Country [73]
0
0
Israel
Query!
State/province [73]
0
0
Haifa
Query!
Country [74]
0
0
Israel
Query!
State/province [74]
0
0
Jerusalem
Query!
Country [75]
0
0
Israel
Query!
State/province [75]
0
0
Kfar Saba
Query!
Country [76]
0
0
Israel
Query!
State/province [76]
0
0
Petah tikva
Query!
Country [77]
0
0
Israel
Query!
State/province [77]
0
0
Ramat Gan
Query!
Country [78]
0
0
Israel
Query!
State/province [78]
0
0
Tel Aviv
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Milano
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
Pordenone
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Verona
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
Bergamo
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Bologna
Query!
Country [84]
0
0
Italy
Query!
State/province [84]
0
0
Cona
Query!
Country [85]
0
0
Italy
Query!
State/province [85]
0
0
Genova
Query!
Country [86]
0
0
Italy
Query!
State/province [86]
0
0
Lecco
Query!
Country [87]
0
0
Italy
Query!
State/province [87]
0
0
Messina
Query!
Country [88]
0
0
Italy
Query!
State/province [88]
0
0
Modena
Query!
Country [89]
0
0
Italy
Query!
State/province [89]
0
0
Napoli
Query!
Country [90]
0
0
Italy
Query!
State/province [90]
0
0
Padova
Query!
Country [91]
0
0
Italy
Query!
State/province [91]
0
0
Parma
Query!
Country [92]
0
0
Italy
Query!
State/province [92]
0
0
Pavia
Query!
Country [93]
0
0
Italy
Query!
State/province [93]
0
0
Pisa
Query!
Country [94]
0
0
Italy
Query!
State/province [94]
0
0
Torino
Query!
Country [95]
0
0
Japan
Query!
State/province [95]
0
0
Fukushima-Ken
Query!
Country [96]
0
0
Japan
Query!
State/province [96]
0
0
Osaka-Fu
Query!
Country [97]
0
0
Japan
Query!
State/province [97]
0
0
Tokyo-To
Query!
Country [98]
0
0
Japan
Query!
State/province [98]
0
0
Ehime
Query!
Country [99]
0
0
Japan
Query!
State/province [99]
0
0
Fukuoka
Query!
Country [100]
0
0
Japan
Query!
State/province [100]
0
0
Hiroshima
Query!
Country [101]
0
0
Japan
Query!
State/province [101]
0
0
Hokkaido
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Hyogo
Query!
Country [103]
0
0
Japan
Query!
State/province [103]
0
0
Kanagawa
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Kyoto
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Miyagi
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Nagoya
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Niigata
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Okayama
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Osaka
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Saitama
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Shizuoka
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Tokyo
Query!
Country [113]
0
0
Korea, Republic of
Query!
State/province [113]
0
0
Chungcheongbuk-do
Query!
Country [114]
0
0
Korea, Republic of
Query!
State/province [114]
0
0
Gyeonggi-do
Query!
Country [115]
0
0
Korea, Republic of
Query!
State/province [115]
0
0
Daegu
Query!
Country [116]
0
0
Korea, Republic of
Query!
State/province [116]
0
0
Goyang-si
Query!
Country [117]
0
0
Korea, Republic of
Query!
State/province [117]
0
0
Seoul
Query!
Country [118]
0
0
Spain
Query!
State/province [118]
0
0
Barcelona
Query!
Country [119]
0
0
Spain
Query!
State/province [119]
0
0
Cádiz
Query!
Country [120]
0
0
Spain
Query!
State/province [120]
0
0
La Coruña
Query!
Country [121]
0
0
Spain
Query!
State/province [121]
0
0
Tenerife
Query!
Country [122]
0
0
Spain
Query!
State/province [122]
0
0
Badajoz
Query!
Country [123]
0
0
Spain
Query!
State/province [123]
0
0
Lleida
Query!
Country [124]
0
0
Spain
Query!
State/province [124]
0
0
Madrid
Query!
Country [125]
0
0
Spain
Query!
State/province [125]
0
0
Málaga
Query!
Country [126]
0
0
Spain
Query!
State/province [126]
0
0
Salamanca
Query!
Country [127]
0
0
Spain
Query!
State/province [127]
0
0
Sevilla
Query!
Country [128]
0
0
Spain
Query!
State/province [128]
0
0
Valencia
Query!
Country [129]
0
0
Spain
Query!
State/province [129]
0
0
Zaragoza
Query!
Country [130]
0
0
Turkey
Query!
State/province [130]
0
0
Adana
Query!
Country [131]
0
0
Turkey
Query!
State/province [131]
0
0
Ankara
Query!
Country [132]
0
0
Turkey
Query!
State/province [132]
0
0
Antalya
Query!
Country [133]
0
0
Turkey
Query!
State/province [133]
0
0
Bursa
Query!
Country [134]
0
0
Turkey
Query!
State/province [134]
0
0
Istanbul
Query!
Country [135]
0
0
Turkey
Query!
State/province [135]
0
0
Izmir
Query!
Country [136]
0
0
Turkey
Query!
State/province [136]
0
0
Konya
Query!
Country [137]
0
0
Turkey
Query!
State/province [137]
0
0
Sakarya
Query!
Country [138]
0
0
Turkey
Query!
State/province [138]
0
0
Samsun
Query!
Country [139]
0
0
Turkey
Query!
State/province [139]
0
0
Tekirdag
Query!
Country [140]
0
0
United Kingdom
Query!
State/province [140]
0
0
Cornwall
Query!
Country [141]
0
0
United Kingdom
Query!
State/province [141]
0
0
Devon
Query!
Country [142]
0
0
United Kingdom
Query!
State/province [142]
0
0
Grampian Region
Query!
Country [143]
0
0
United Kingdom
Query!
State/province [143]
0
0
Greater London
Query!
Country [144]
0
0
United Kingdom
Query!
State/province [144]
0
0
Lothian Region
Query!
Country [145]
0
0
United Kingdom
Query!
State/province [145]
0
0
Nottinghamshire
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Daiichi Sankyo
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Daiichi Sankyo Co., Ltd.
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Commercial sector/industry
Query!
Name [2]
0
0
AstraZeneca
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: * cannot be removed by an operation * has spread to other parts of the body
Query!
Trial website
https://clinicaltrials.gov/study/NCT03523585
Query!
Trial related presentations / publications
Andre F, Hee Park Y, Kim SB, Takano T, Im SA, Borges G, Lima JP, Aksoy S, Gavila Gregori J, De Laurentiis M, Bianchini G, Roylance R, Miyoshi Y, Armstrong A, Sinha R, Ruiz Borrego M, Lim E, Ettl J, Yerushalmi R, Zagouri F, Duhoux FP, Fehm T, Gambhire D, Cathcart J, Wu C, Chu C, Egorov A, Krop I. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 May 27;401(10390):1773-1785. doi: 10.1016/S0140-6736(23)00725-0. Epub 2023 Apr 20. Erratum In: Lancet. 2023 Dec 9;402(10418):2196. doi: 10.1016/S0140-6736(23)02709-5. Lancet. 2024 Mar 9;403(10430):912. doi: 10.1016/S0140-6736(24)00420-3.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Global Team Leader
Query!
Address
0
0
Daiichi Sankyo
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
De-identified individual participant data (IPD) on completed studies 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/
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
Query!
When will data be available (start and end dates)?
Completed studies that has reached a global end or completion with all data set collected and analyzed, and 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.
Query!
Available to whom?
Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed 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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/daiichi-sankyo/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/85/NCT03523585/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/85/NCT03523585/Prot_SAP_000.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Andre F, Hee Park Y, Kim SB, Takano T, Im SA, Borg...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT03523585