Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer
NCT07022483 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 710
Last updated 2026-02-04
Summary
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.
Conditions
Interventions
- DRUG
-
T-DXd will be administered at a dose of 5.4 mg/kg IV Q3W.
- DRUG
-
Carboplatin AUC 5 or 6 and paclitaxel will be administered at a dose of 175 mg/m2 Q3W, or carboplatin AUC 5 or 6 and paclitaxel 175 mg/m2 Q3W followed by chemoradiotherapy.
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-30
- Primary Completion
- 2032-03-23
- Completion
- 2032-03-23
- FDA Drug
- Yes
Countries
- United States
- China
- Japan
- South Korea
- Taiwan
Study Locations
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