Trastuzumab deruxtecan (T-DXd) with or without Pertuzumab versus Taxane, Trastuzumab and Pertuzumab in HER2-positive metastatic Breast Cancer (DESTINY-Breast09)
Study identifier:D967UC00001
ClinicalTrials.gov identifier:NCT04784715
EudraCT identifier:2020-004074-21
CTIS identifier:N/A
Recruitment Complete
Official 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)
Medical condition
Breast Cancer; HER2-positive; metastatic
Phase
Phase 3
Healthy volunteers
No
Study drug
Trastuzumab deruxtecan, Placebo, Taxane, Pertuzumab, Trastuzumab
Sex
All
Actual Enrollment
1157
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 26 Apr 2021
Estimated Primary Completion Date: 24 Jul 2025
Estimated Study Completion Date: 30 Dec 2029
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 May 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Daiichi Sankyo
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm A Trastuzumab deruxtecan (T-DXd) plus pertuzumab-matching placebo | Drug: Trastuzumab deruxtecan Administered by intravenous infusion Other Name: DS-8201a; T-DXd Drug: Placebo Administered by intravenous infusion |
| Experimental: Arm B Trastuzumab deruxtecan (T-DXd) plus pertuzumab | Drug: Trastuzumab deruxtecan Administered by intravenous infusion Other Name: DS-8201a; T-DXd Drug: Pertuzumab Administered by intravenous infusion |
| Active Comparator: Arm C Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab) | Drug: Taxane Investigator's choice of docetaxel or paclitaxel administered by intravenous infusion Drug: Pertuzumab Administered by intravenous infusion Drug: Trastuzumab Administered by intravenous infusion |
