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Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer

StatusRecruiting
PhasePhase 3
Started2025-09-30
View on ClinicalTrials.gov ↗

Amendment history

2026-07-27
Study Status, Contacts/Locations v6
Trial sites expanded: 61 → 75 locations
2026-05-27
Study Status, Contacts/Locations v5
Trial sites expanded: 40 → 61 locations
2026-02-03
Study Status, Contacts/Locations v4
Study sites17→40
2025-12-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-10-31→confirmed 2025-09-30
Study sites0→17
2025-10-31
Study Status, Eligibility v2
Eligibility criteria+201 characters
[...] age IIC includes disease with aggressive histological types (aggressive histological types are composed of high-grade EECs (grade 3), serous, clear cell, undifferentiated, mixed, mesonephric-like, gastrointestinal mucinous type carcinomas, and carcinosarcomas) with any myometrial involvement. FIGO 2023 Stage III include [...] symptoms should have a cardiologic consultation during SCR periodPeriod to rule out MI. Has a QTcF prolongation to > 480 msec based [...]
2025-09-17
Study Status v1
Start date2025-08-25→2025-10-31
2025-06-06
Original filing
This study is designed to assess efficacy and safety of T-DXd adjuvant therapy, with or without radiotherapy, post-surgery in anticancer treatment naïve (including neoadjuvant therapy) endometrial cancer with various HER2 expression levels.
Trial Details
NCT Number NCT07022483
Lead Sponsor Daiichi Sankyo
Collaborators: AstraZeneca
Conditions Endometrial Cancer
Enrollment 710 participants
Start Date 2025-09-30
Primary Completion 2032-03-23 (estimated)
Study Completion 2032-03-23 (estimated)
Updated on ClinicalTrials.gov 2026-07-28