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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03523585




Registration number
NCT03523585
Ethics application status
Date submitted
13/04/2018
Date registered
14/05/2018
Date last updated
2/04/2024

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
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St Vincent's Hospital Sydney - Darlinghurst
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Liverpool Hospital - Liverpool
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Macquarie University Hospital - Sydney
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The Tweed Hospital - Tweed Heads
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Princess Alexandra Hospital - Woolloongabba
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Ashford Cancer Centre Research - Kurralta Park
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Box Hill Hospital - Box Hill
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Frankston Hospital - Frankston
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Peninsula and South Eastern Haematology & Oncology Group - Frankston
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Austin Health - Heidelberg
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Peter MacCallum Cancer Centre - Melbourne
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Sunshine Hospital - Saint Albans
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South West Oncology - Warrnambool
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Ballarat Oncology & Haematology Service - Wendouree
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St John of God Subiaco Hospital - Subiaco
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Calvary North Adelaide Hospital - Bruce
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2010 - Darlinghurst
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2170 - Liverpool
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2109 - Sydney
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2485 - Tweed Heads
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4102 - Woolloongabba
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5037 - Kurralta Park
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3128 - Box Hill
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3199 - Frankston
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3084 - Heidelberg
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3000 - Melbourne
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3021 - Saint Albans
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3280 - Warrnambool
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3355 - Wendouree
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6008 - Subiaco
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2614 - Bruce
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Madrid
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Salamanca
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Sevilla
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Valencia
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Zaragoza
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Turkey
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Adana
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Ankara
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Antalya
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Bursa
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Istanbul
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Izmir
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Konya
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Sakarya
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Samsun
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Tekirdag
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United Kingdom
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Cornwall
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Devon
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Grampian Region
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Greater London
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Lothian Region
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United Kingdom
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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
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/ct2/show/NCT03523585
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03523585