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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]
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
Secondary ID [1] 0 0
2018-000221-31
Secondary ID [2] 0 0
DS8201-A-U301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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
Timepoint [1] 0 0
Baseline up to 46 months postdose
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
Timepoint [1] 0 0
Baseline up to 46 months postdose
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
Timepoint [2] 0 0
Baseline up to 46 months postdose
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
Timepoint [3] 0 0
Baseline up to 46 months postdose
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
Timepoint [4] 0 0
Up to 46 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
Accrual to date
Final
608
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Macquarie University Hospital - Sydney
Recruitment hospital [4] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [7] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [8] 0 0
Frankston Hospital - Frankston
Recruitment hospital [9] 0 0
Peninsula and South Eastern Haematology & Oncology Group - Frankston
Recruitment hospital [10] 0 0
Austin Health - Heidelberg
Recruitment hospital [11] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [12] 0 0
Sunshine Hospital - Saint Albans
Recruitment hospital [13] 0 0
South West Oncology - Warrnambool
Recruitment hospital [14] 0 0
Ballarat Oncology & Haematology Service - Wendouree
Recruitment hospital [15] 0 0
St John of God Subiaco Hospital - Subiaco
Recruitment hospital [16] 0 0
Calvary North Adelaide Hospital - Bruce
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2109 - Sydney
Recruitment postcode(s) [4] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3199 - Frankston
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
3000 - Melbourne
Recruitment postcode(s) [11] 0 0
3021 - Saint Albans
Recruitment postcode(s) [12] 0 0
3280 - Warrnambool
Recruitment postcode(s) [13] 0 0
3355 - Wendouree
Recruitment postcode(s) [14] 0 0
6008 - Subiaco
Recruitment postcode(s) [15] 0 0
2614 - Bruce
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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Connecticut
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Hawaii
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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Maine
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Maryland
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Massachusetts
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Michigan
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Missouri
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New York
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Belgium
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Bruxelles
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Belgium
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Gent
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Kortrijk
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Belgium
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Leuven
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Belgium
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Namur
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Brazil
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Bahia
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Brazil
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Ceará
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Brazil
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Minas Gerais
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Brazil
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Rio Grande Do Sul
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Brazil
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Santa Catarina
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Brazil
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Sao Paulo
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Brazil
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Rio De Janeiro
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Brazil
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São Paulo
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Czechia
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Brno
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Czechia
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Olomouc
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Czechia
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Prague 5
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Czechia
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Praha
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France
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Bouches-du-Rhône
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France
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Cotes d'Armor
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Doubs
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France
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Finistere
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Hauts De Seine
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Herault
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Ille Et Vilaine
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Nord
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Paris
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Pyrenees Atlantiques
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Sarthe
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Vaculuse
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Val De Marne
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Montpellier
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Germany
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Bayern
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Germany
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Rheinland Pfalz
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Germany
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Schleswig Holstein
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Germany
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Berlin
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Germany
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Düsseldorf
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Germany
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Erlangen
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Koeln
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Leipzig
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Germany
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Munich
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Germany
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Müenster
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Germany
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Troisdorf
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Greece
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Athens
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Heraklion
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Thessaloníki
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Israel
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Haifa
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Jerusalem
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Kfar Saba
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Petah tikva
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Israel
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Ramat Gan
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Tel Aviv
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Milano
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Pordenone
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Verona
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Bergamo
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Italy
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Bologna
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Cona
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Italy
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Genova
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Italy
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Lecco
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Italy
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Messina
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Italy
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Modena
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Italy
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Napoli
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Italy
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Padova
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Italy
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Parma
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Italy
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Pavia
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Italy
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Pisa
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Italy
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Torino
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Japan
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Fukushima-Ken
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Japan
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Osaka-Fu
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Japan
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Tokyo-To
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Kyoto
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Japan
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Miyagi
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Japan
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Nagoya
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Japan
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Niigata
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Shizuoka
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Japan
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Tokyo
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Korea, Republic of
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Chungcheongbuk-do
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Daegu
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Seoul
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Spain
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Barcelona
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Spain
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Cádiz
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Spain
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La Coruña
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Spain
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Tenerife
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Spain
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Badajoz
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Spain
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Lleida
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Salamanca
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Zaragoza
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Turkey
State/province [130] 0 0
Adana
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Turkey
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Ankara
Country [132] 0 0
Turkey
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Antalya
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Turkey
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Bursa
Country [134] 0 0
Turkey
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Istanbul
Country [135] 0 0
Turkey
State/province [135] 0 0
Izmir
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Turkey
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Konya
Country [137] 0 0
Turkey
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Sakarya
Country [138] 0 0
Turkey
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Samsun
Country [139] 0 0
Turkey
State/province [139] 0 0
Tekirdag
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Cornwall
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Devon
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Grampian Region
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Greater London
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Lothian Region
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Nottinghamshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Daiichi Sankyo
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Daiichi Sankyo Co., Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
AstraZeneca
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Team Leader
Address 0 0
Daiichi Sankyo
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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.
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/daiichi-sankyo/


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations 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