Trastuzumab deruxtecan (T-DXd) alone or in sequence with THP, versus standard treatment (ddAC-THP), in HER2-positive early breast cancer
Study identifier:D967RC00001
ClinicalTrials.gov identifier:NCT05113251
EudraCT identifier:2021-000603-21
CTIS identifier:N/A
Recruitment Complete
Official Title
A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd followed by THP Compared to ddAC-THP in Participants with High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11)
Medical condition
Breast Neoplasms
Phase
Phase 3
Healthy volunteers
No
Study drug
Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab, Pertuzumab, Doxorubicin, cyclophosphamide
Sex
All
Actual Enrollment
927
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 25 Oct 2021
Estimated Primary Completion Date: 12 Mar 2025
Estimated Study Completion Date: 30 Apr 2027
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Daiichi-Sankyo
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm A Trastuzumab deruxtecan | Drug: Trastuzumab Deruxtecan administered by intravenous infusion Other Name: T-DXd Other Name: Enhertu |
| Experimental: Arm B T-DXd, followed by THP | Drug: Trastuzumab Deruxtecan administered by intravenous infusion Other Name: T-DXd Other Name: Enhertu Drug: Paclitaxel administered by intravenous infusion Other Name: Taxol Other Name: Onxol Drug: Trastuzumab administered by intravenous infusion Other Name: Herceptin Other Name: Herzuma Drug: Pertuzumab administered by intravenous infusion Other Name: Perjeta |
| Active Comparator: Arm C doxorubicin and cyclophosphamide, followed by THP | Drug: Paclitaxel administered by intravenous infusion Other Name: Taxol Other Name: Onxol Drug: Trastuzumab administered by intravenous infusion Other Name: Herceptin Other Name: Herzuma Drug: Pertuzumab administered by intravenous infusion Other Name: Perjeta Drug: Doxorubicin administered by intravenous infusion Other Name: Adriamycin Other Name: Rubex Drug: cyclophosphamide administered by intravenous infusion Other Name: Neosar Other Name: Cytoxan |
