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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/NCT04784715




Registration number
NCT04784715
Ethics application status
Date submitted
19/02/2021
Date registered
5/03/2021
Date last updated
1/09/2023

Titles & IDs
Public title
Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)
Scientific title
Phase III Study of Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)
Secondary ID [1] 0 0
2020-004074-21
Secondary ID [2] 0 0
D967UC00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer; HER2-positive; Metastatic 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 - Placebo
Treatment: Drugs - Taxane
Treatment: Drugs - Pertuzumab
Treatment: Drugs - Trastuzumab

Experimental: Arm A - Trastuzumab deruxtecan (T-DXd) plus pertuzumab-matching placebo

Experimental: Arm B - Trastuzumab deruxtecan (T-DXd) plus pertuzumab

Active Comparator: Arm C - Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)


Treatment: Drugs: Trastuzumab deruxtecan
Administered by intravenous infusion

Treatment: Drugs: Placebo
Administered by intravenous infusion

Treatment: Drugs: Taxane
Investigator's choice of docetaxel or paclitaxel administered by intravenous infusion

Treatment: Drugs: Pertuzumab
Administered by intravenous infusion

Treatment: Drugs: Trastuzumab
Administered by intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment
Timepoint [1] 0 0
Until progression or death, assessed up to approximately 60 months
Secondary outcome [1] 0 0
Progression Free Survival (PFS) by Investigator assessment
Timepoint [1] 0 0
Until progression or death, assessed up to approximately 60 months
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Until death, assessed up to approximately 104 months
Secondary outcome [3] 0 0
Objective Response Rate (ORR) by BICR and Investigator assessment
Timepoint [3] 0 0
Until progression or death (in the absence of progression), assessed up to approximately 60 months
Secondary outcome [4] 0 0
Duration of Response (DoR) by BICR and Investigator Assessment
Timepoint [4] 0 0
Until progression or death (in the absence of progression), assessed up to approximately 60 months
Secondary outcome [5] 0 0
Time to second progression or death (PFS2) by Investigator assessment
Timepoint [5] 0 0
Assessed up to approximately 104 months
Secondary outcome [6] 0 0
To assess the effect of T-DXd ± pertuzumab relative to THP in terms of patient-reported pain in participants with HER2 positive, first-line mBC'.
Timepoint [6] 0 0
Assessed up to approximately 60 months
Secondary outcome [7] 0 0
To assess patient-reported treatment tolerability
Timepoint [7] 0 0
Assessed up to approximately 60 months
Secondary outcome [8] 0 0
To assess patient-reported treatment tolerability
Timepoint [8] 0 0
Assessed up to approximately 60 months
Secondary outcome [9] 0 0
To assess patient-reported treatment tolerability
Timepoint [9] 0 0
Assessed up to approximately 60 months
Secondary outcome [10] 0 0
To assess patient-reported treatment tolerability
Timepoint [10] 0 0
Assessed up to approximately 60 months
Secondary outcome [11] 0 0
To assess patient-reported treatment tolerability
Timepoint [11] 0 0
Assessed up to approximately 60 months
Secondary outcome [12] 0 0
Serum concentration of trastuzumab deruxtecan and pertuzumab
Timepoint [12] 0 0
Up to Cycle 6, approximately Week 18; each cycle is 21 days
Secondary outcome [13] 0 0
Immunogenicity of trastuzumab deruxtecan.
Timepoint [13] 0 0
Up to follow-up period, approximately 60 months
Secondary outcome [14] 0 0
Safety and tolerability of trastuzumab deruxtecan, alone or with pertuzumab
Timepoint [14] 0 0
Assessed up to approximately 60 months

Eligibility
Key inclusion criteria
Key

- Patients must be =18 years of age

- Pathologically documented breast cancer that:

1. is advanced or metastatic

2. is locally assessed and prospectively centrally confirmed as HER2-positive (IHC3+
or ISH+)

3. is documented by local testing as hormone receptor (HR)-positive or HR-negative
disease in the metastatic setting

- No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast
cancer or only 1 previous line of endocrine therapy in the metastatic setting.
Participants who have received chemotherapy or HER2-targeted therapy in the
neo-adjuvant or adjuvant setting are eligible if > 6 months from treatment to
metastatic diagnosis.

- Has protocol-defined adequate organ and bone marrow function

- ECOG performance status 0 or 1

Key
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Ineligible for any of the agents on the study.

- Any substance abuse or other medical conditions that, in the investigator's opinion,
may interfere with subject's participation or study results

- Patients with spinal cord compression or clinically active central nervous system
metastases. Participants with clinically inactive brain metastases or treated brain
metastases that are no longer symptomatic may be included in the study.

- Active or prior documented interstitial lung disease (ILD)/pneumonitis or suspected
ILD/pneumonitis that cannot be ruled out by imaging at screening

- Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless
of treatment arm assignment

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
26/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2029
Actual
Sample size
Target
1134
Accrual to date
Final
Recruitment in Australia
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Recruitment outside Australia
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Russian Federation
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Taunton

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

Ethics approval
Ethics application status

Summary
Brief summary
The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as
T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with
Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of
treatment in the metastatic setting.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04784715
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04784715