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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04784715
Registration number
NCT04784715
Ethics application status
Date submitted
19/02/2021
Date registered
5/03/2021
Date last updated
1/08/2025
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)
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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)
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Secondary ID [1]
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2023-507904-30-00
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Secondary ID [2]
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D967UC00001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer; HER2-positive; Metastatic
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment
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Assessment method [1]
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Defined as time from date of randomisation until the date of objective radiological disease progression according to Blinded Independent Central Review (BICR) using RECIST 1.1 or death by any cause.
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Timepoint [1]
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Until progression or death, assessed up to approximately 60 months
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Secondary outcome [1]
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Progression Free Survival (PFS) by Investigator assessment
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Assessment method [1]
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Defined as time from date of randomisation until the date of objective radiological disease progression according to Investigator using RECIST 1.1 or death by any cause.
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Timepoint [1]
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Until progression or death, assessed up to approximately 60 months
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as the time from randomisation until the date of death due to any cause.
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Timepoint [2]
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Until death, assessed up to approximately 104 months
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Secondary outcome [3]
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Objective Response Rate (ORR) by BICR and Investigator assessment
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Assessment method [3]
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ORR is defined as The proportion of participants who have a complete response (CR) or partial response (PR) based on BICR and investigator assessment using RECIST 1.1.
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Timepoint [3]
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Until progression or death (in the absence of progression), assessed up to approximately 60 months
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Secondary outcome [4]
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Duration of Response (DoR) by BICR and Investigator Assessment
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Assessment method [4]
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DoR is defined as the time from date of first detection of objective response until the date of objective radiological disease progression according to BICR and investigator assessment using RECIST 1.1 or death in the absence of progression.
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Timepoint [4]
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Until progression or death (in the absence of progression), assessed up to approximately 60 months
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Secondary outcome [5]
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Time to second progression or death (PFS2) by Investigator assessment
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Assessment method [5]
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PFS2 is defined as the time from randomisation until the date of tumor progression on next-line treatment (the earliest of the progression event subsequent to first subsequent anticancer therapy after the first progression) or death from any cause; second progression will be defined according to local standard clinical practice.
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Timepoint [5]
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Assessed up to approximately 104 months
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Secondary outcome [6]
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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'.
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Assessment method [6]
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Pain progression: Time to sustained deterioration of European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Pain Scale. Scores range from 0-100 based on 2 items with responses ranging from 1-4. A lower score would mean better outcome.
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Timepoint [6]
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Assessed up to approximately 60 months
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Secondary outcome [7]
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To assess patient-reported treatment tolerability
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Assessment method [7]
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Proportion of participants experiencing treatment related symptoms as measured by selected items from the European Organisation for Research and Treatment of Cancer, general cancer module (EORTC QLQ-C30), score of 1-4. A lower score would mean better outcome.
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Timepoint [7]
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Assessed up to approximately 60 months
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Secondary outcome [8]
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To assess patient-reported treatment tolerability
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Assessment method [8]
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Proportion of patients reporting different levels of overall tolerability as measured by the Patient Global Impression of Treatment Tolerability (PGI-TT), score of 0-4. A lower score would mean a better outcome.
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Timepoint [8]
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0
Assessed up to approximately 60 months
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Secondary outcome [9]
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To assess patient-reported treatment tolerability
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Assessment method [9]
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Proportion of participants experiencing treatment related symptoms as measured by selected items from the European Organisation for Research and Treatment of Cancer, breast cancer module (EORTC QLQ-BR45), score of 1-4. A lower score would mean better outcome.
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Timepoint [9]
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0
Assessed up to approximately 60 months
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Secondary outcome [10]
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To assess patient-reported treatment tolerability
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Assessment method [10]
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Proportion of participants experiencing treatment related symptoms as measured by selected items from the Patient-Reported Outcomes- Common Terminology Criteria for Adverse Events (PRO-CTCAE). PRO-CTCAE responses are scored from 0 to 4 (or 0/1 for absent/present). A lower score would mean a better outcome.
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Timepoint [10]
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Assessed up to approximately 60 months
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Secondary outcome [11]
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To assess patient-reported treatment tolerability
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Assessment method [11]
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The proportion of participants with maintained or improved physical function while on treatment, based on the EORTC QLQ-C30 Physical Functioning scale. Scores range from 0-100, based on 5 items with responses ranging from 1-4. A higher score would mean a better outcome.
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Timepoint [11]
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Assessed up to approximately 60 months
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Secondary outcome [12]
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Serum concentration of trastuzumab deruxtecan and pertuzumab
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Assessment method [12]
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Determination of trastuzumab deruxtecan and pertuzumab concentrations in serum.
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Timepoint [12]
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Up to Cycle 6, approximately Week 18; each cycle is 21 days
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Secondary outcome [13]
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Immunogenicity of trastuzumab deruxtecan.
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Assessment method [13]
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Number and percentage of participants who develop anti-drug antibody (ADA) for trastuzumab deruxtecan.
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Timepoint [13]
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Up to follow-up period, approximately 60 months
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Secondary outcome [14]
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Safety and tolerability of trastuzumab deruxtecan, alone or with pertuzumab
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Assessment method [14]
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Number of AEs according to NCI-CTCAE Version 5.0 per each treatment arm
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Timepoint [14]
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Assessed up to approximately 60 months
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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
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Minimum age
18
Years
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Maximum age
130
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/04/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/12/2029
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Actual
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Sample size
Target
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Accrual to date
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Final
1157
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Recruitment in Australia
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India
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Bengaluru
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India
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Calicut
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India
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Gurgaon
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India
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Mysuru
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India
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Nashik
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India
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New Delhi
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Israel
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Haifa
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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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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Bergamo
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Italy
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Candiolo
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Italy
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Genova
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Italy
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Livorno
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Italy
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Milan
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Italy
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Napoli
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Italy
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Padua
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Italy
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Rozzano
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Italy
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Udine
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Akashi-shi
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Aomori
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Bunkyo City
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Chiba
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Japan
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Chuoku
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Japan
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Fukushima
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Hidaka-shi
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Hiroshima
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Isehara-shi
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Kagoshima
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Kawasaki-shi
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Kobe
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Kotoku
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Japan
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Kurume-shi
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Kyoto
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Matsuyama
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Japan
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Nagoya
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Japan
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Niigata
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Nishinomiya-shi
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Okayama
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Japan
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Osaka
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Japan
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Ota-shi
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Japan
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Sapporo
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Japan
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Sendai
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Japan
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Shinagawa-ku
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Japan
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Shinjuku-ku
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Japan
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Shizuoka
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Japan
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Tsu
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Japan
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Yokohama
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Mexico
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Alc. Cuauhtémoc
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Mexico
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Estado de México
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Guadalajara
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Mexico
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Metepec
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Mexico
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Nuevo León
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Mexico
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Veracruz
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Peru
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Arequipa
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Peru
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Lima
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Baguio City
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Manila
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Philippines
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Quezon City
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Philippines
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Romania
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Bucharest
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Romania
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Floresti
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Russia
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Moscow
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Russia
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Saint Petersburg
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Russia
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Yaroslavl
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Dammam
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Jeddah
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Riyadh
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Cape Town
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George
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Port Elizabeth
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Pretoria
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Rondebosch
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Soweto
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Daegu
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Goyang-si
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Seoul
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Spain
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Alicante
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Barcelona
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Madrid
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Spain
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Seville
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Gothenburg
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Stockholm
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Uppsala
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Vaxjo
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Taichung
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Taiwan
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Taoyuan District
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Adana
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Samsun
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United Kingdom
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Buckhurst Hill
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Edinburgh
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Guildford
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London
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United Kingdom
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Manchester
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Swansea
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United Kingdom
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Taunton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
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Daiichi Sankyo
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Address [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT04784715
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Trial related presentations / publications
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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
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Contacts
Principal investigator
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Fax
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Contact person for public queries
Name
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0
AstraZeneca Clinical Study Information Center
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Address
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Phone
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0
1-877-240-9479
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Fax
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04784715
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