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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03529110




Registration number
NCT03529110
Ethics application status
Date submitted
13/04/2018
Date registered
18/05/2018

Titles & IDs
Public 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]
Scientific 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
Secondary ID [1] 0 0
2018-000222-61
Secondary ID [2] 0 0
DS8201-A-U302
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 (T-DXd)
Treatment: Drugs - Ado-trastuzumab emtansine (T-DM1)

Experimental: Trastuzumab deruxtecan (T-DXd) - 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).

Active comparator: Ado-trastuzumab emtansine (T-DM1) - 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.


Treatment: Drugs: Trastuzumab deruxtecan (T-DXd)
T-DXd is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously.

Treatment: Drugs: Ado-trastuzumab emtansine (T-DM1)
The treatment will be in accordance with the approved label.
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 Previously Treated With Trastuzumab and Taxane
Timepoint [1] 0 0
Up to 33 months (data cut-off)
Secondary outcome [1] 0 0
Overall Survival (OS) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
Timepoint [1] 0 0
Up to 33 months (data cut-off)
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Up to 33 months (data cut-off)
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Up to 33 months (data cut-off)
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Up to 33 months (data cut-off)

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

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
9/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
Accrual to date
Final
524
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
Peninsula and South Eastern Haematology & Oncology Group - Frankston
Recruitment hospital [5] 0 0
Peter MacCallum Cancer - Melbourne
Recruitment hospital [6] 0 0
St John of God Subiaco Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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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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Illinois
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United States of America
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Kentucky
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United States of America
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Massachusetts
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United States of America
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Nebraska
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Belgium
State/province [16] 0 0
Bruxelles
Country [17] 0 0
Belgium
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Edegem
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Belgium
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Gent
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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
State/province [21] 0 0
Bahia
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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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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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China
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Beijing
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China
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Guangdong
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China
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Heilongjiang
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China
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Jilin
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China
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Liaoning
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China
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Shanghai
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China
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Sichuan
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China
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Tianjin
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China
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Zhejiang
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France
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Bas Rhin
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France
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Bouches-du-Rhone
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France
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Calvados
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France
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Cedex 02, Sarthe
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France
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Cotes d'Armor
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France
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Côte-d'Or
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France
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Doubs
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France
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Gironde
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France
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Hauts De Seine
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France
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Herault
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France
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Ille Et Vilaine
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France
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Loire Atlantique
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France
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Maine Et Loire
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France
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Nord
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France
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Rhone
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France
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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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Paris
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Germany
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Bayern
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Germany
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Nordrhein Westfalen
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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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Hong Kong
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Hong Kong
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Hong Kong
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Shatin
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Italy
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Ferrara
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Italy
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Milano
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Italy
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Pordenone
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Italy
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Bergamo
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Italy
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Bologna
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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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Parma
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Italy
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Pavia
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Italy
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Torino
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Japan
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Tokyo-To
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Japan
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Aichi
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Ehime
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Fukuoka
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Hiroshima
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Hokkaido
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Kanagawa
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Kumamoto
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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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Gyeonggi-do
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Korea, Republic of
State/province [91] 0 0
Seoul
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Spain
State/province [92] 0 0
Barcelona
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Spain
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La Coruña
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Spain
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Madrid
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Spain
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Sevill
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Spain
State/province [96] 0 0
Tenerife
Country [97] 0 0
Spain
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Badajoz
Country [98] 0 0
Spain
State/province [98] 0 0
Málaga
Country [99] 0 0
Spain
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Sevilla
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Taiwan
State/province [100] 0 0
Taichung
Country [101] 0 0
Taiwan
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Tainan
Country [102] 0 0
Taiwan
State/province [102] 0 0
Taipei
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Devon
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Grampian Region
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Greater London
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Greater Manchester
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Lothian Region
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Nottinghamshire
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Surrey

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) 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), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
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

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03529110