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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03523585




Registration number
NCT03523585
Ethics application status
Date submitted
13/04/2018
Date registered
14/05/2018
Date last updated
20/08/2019

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 DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including 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) - Time from the date of randomization to the first objective documentation of radiographic disease progression via BICR according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1, or death due to any cause.
Timepoint [1] 0 0
Within 45 months
Secondary outcome [1] 0 0
Overall survival (OS) - Time from the date of randomization to the date of death for 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.
Timepoint [1] 0 0
At 45 months
Secondary outcome [2] 0 0
Objective response rate (ORR) based on BICR and investigator assessment - Percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR), based on BICR and investigator assessment
Timepoint [2] 0 0
Within 45 months
Secondary outcome [3] 0 0
Duration of response (DoR) based on BICR and investigator's assessment - Length of time response continued, based on BICR and investigator's assessment
Timepoint [3] 0 0
Within 45 months
Secondary outcome [4] 0 0
Clinical benefit rate (CBR) based on BICR and investigator assessment - Percentage of participants receiving clinical benefit (CR, PR or more than 6 months stable disease) from the treatment based on BICR and investigator assessment
Timepoint [4] 0 0
Within 45 months
Secondary outcome [5] 0 0
Progression-free survival (PFS) based on investigator's assessment - Time from the date of randomization to the first objective documentation of radiographic disease progression via investigator assessment, according to mRECIST version 1.1, or death due to any cause.
Timepoint [5] 0 0
Within 45 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. 4.5 months after the last dose of DS-8201a

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
Gender
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

- 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,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
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Peninsula and South Eastern Haematology & Oncology Group - Frankston
Recruitment hospital [6] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [7] 0 0
Sunshine Hospital - Saint Albans
Recruitment hospital [8] 0 0
St John of God Subiaco Hospital - Subiaco
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
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment postcode(s) [7] 0 0
3021 - Saint Albans
Recruitment postcode(s) [8] 0 0
6008 - Subiaco
Recruitment outside Australia
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United States of America
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Arizona
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California
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Connecticut
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District of Columbia
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Georgia
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Indiana
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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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Texas
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United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Belgium
State/province [19] 0 0
Bruxelles
Country [20] 0 0
Belgium
State/province [20] 0 0
Gent
Country [21] 0 0
Belgium
State/province [21] 0 0
Kortrijk
Country [22] 0 0
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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Santa Catarina
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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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Prague 5
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Czechia
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Praha
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Doubs
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Herault
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France
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Nord
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France
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Paris
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France
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Pyrenees Atlantiques
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Rhone
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Sarthe
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Vaculuse
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France
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Val De Marne
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France
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Montpellier
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Greece
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Athens
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Greece
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Thessaloníki
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Israel
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Jerusalem
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Israel
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Petah tikva
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Israel
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Tel Aviv
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Italy
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Milano
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Italy
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Pordenone
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Bergamo
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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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Napoli
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Italy
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Parma
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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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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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Hyogo
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Kanagawa
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Kyoto
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Miyagi
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Nagoya
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Niigata
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Okayama
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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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Seoul
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Spain
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Barcelona
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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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Madrid
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Spain
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Sevilla
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Spain
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Valencia
Country [87] 0 0
Turkey
State/province [87] 0 0
Adana
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Turkey
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Antalya
Country [89] 0 0
Turkey
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Istanbul
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Turkey
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Izmir
Country [91] 0 0
Turkey
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Samsun
Country [92] 0 0
Turkey
State/province [92] 0 0
Tekirdag
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Devon
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Grampian Region
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Greater London
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Lothian Region
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Nottinghamshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Daiichi Sankyo, Inc.
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
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
Trial website
https://clinicaltrials.gov/show/NCT03523585
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Team Leader
Address 0 0
Daiichi Sankyo, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
(For Sites in Asia Only) Daiichi Sankyo Contact for Clinical Trial Information
Address 0 0
Country 0 0
Phone 0 0
+81-3-6225-1111(M-F 9-5 JST)
Fax 0 0
Email 0 0
dsclinicaltrial@daiichisankyo.co.jp
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03523585