Actively Recruiting
Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer
Led by Daiichi Sankyo · Updated on 2026-02-04
710
Participants Needed
40
Research Sites
338 weeks
Total Duration
On this page
Sponsors
D
Daiichi Sankyo
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older at the time of consent
- Histologically confirmed epithelial endometrial carcinoma (carcinosarcomas allowed; sarcomas excluded)
- Newly diagnosed FIGO 2023 Stage IIC (including Stage IICmp53abn) or Stage III
- HER2 expression of IHC 3+ or 2+ confirmed by central laboratory
- Adequate archived tumor tissue sample available for HER2 assessment (surgery sample recommended)
You will not qualify if you...
- Uterine mesenchymal tumors such as endometrial stromal sarcoma, leiomyosarcoma, other pure sarcomas, or adenosarcomas
- Recurrent disease or FIGO 2023 Stage IV
- Measurable residual tumor after surgery as per BICR assessment
- Known POLE mutation from approved/validated local tests if available
- History of myocardial infarction within 6 months before enrollment or symptomatic congestive heart failure (NYHA Class II to IV)
- Troponin levels above the upper limit of normal without MI symptoms unless cardiology consultation rules out MI
- QTcF prolongation over 480 msec on triplicate ECG
- Severe pulmonary compromise from intercurrent pulmonary illnesses or autoimmune/connective tissue disorders with potential lung involvement
- History or current noninfectious interstitial lung disease or pneumonitis requiring corticosteroids, or suspected ILD/pneumonitis not ruled out by imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
2
Trials365 LLC
Shreveport, Louisiana, United States, 71103
Actively Recruiting
3
Avera Medical Group Gynecologic Oncology Sioux Falls
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
4
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
5
The First Hospital of Jilin University
Changchun, China
Actively Recruiting
6
West China Second University Hospital, Sichuan University
Chengdu, China
Actively Recruiting
7
Obstetrics and Gynecology Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
8
Zhejiang Cancer Hospital
Hangzhou, China
Actively Recruiting
9
Cancer Hospital of Shandong First Medical University
Jinan, China
Actively Recruiting
10
Linyi Cancer Hospital
Linyi, China
Actively Recruiting
11
Jiangxi Maternal and Child Health Hospital
Nanchang, China
Actively Recruiting
12
Guangxi Medical University Affiliated Tumor Hospital
Nanning, China
Actively Recruiting
13
Shanghai First Maternity and Infant HospitalShanghai First Maternity and Infant Hospital
Shanghai, China
Actively Recruiting
14
Shanghai Tenth People's Hospital
Shanghai, China
Actively Recruiting
15
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Actively Recruiting
16
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Actively Recruiting
17
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, China
Actively Recruiting
18
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Actively Recruiting
19
Yantai Yuhuangding Hospital
Yantai, China
Actively Recruiting
20
Hyogo Cancer Center
Akashi-shi, Japan
Actively Recruiting
21
NHO Kyushu Cancer Center
Fukuoka, Japan
Actively Recruiting
22
Fukushima Medical University Hospital
Fukushima, Japan
Actively Recruiting
23
Saitama Medical University International Medical Center
Hidaka-shi, Japan
Actively Recruiting
24
Cancer Institute Hospital of JFCR
Kōtoku, Japan
Actively Recruiting
25
Kurume University Hospital
Kurume-shi, Japan
Actively Recruiting
26
Niigata Cancer Center Hospital
Niigata, Japan
Actively Recruiting
27
Okayama University Hospital
Okayama, Japan
Actively Recruiting
28
Gunma Prefectural Cancer Center
Ota-shi, Japan
Actively Recruiting
29
NHO Hokkaido Cancer Center
Sapporo, Japan
Actively Recruiting
30
Tohoku University Hospital
Sendai, Japan
Actively Recruiting
31
Keio University Hospital
Shinjuku-ku, Japan
Actively Recruiting
32
Mie University Hospital
Tsu, Japan
Actively Recruiting
33
Yamagata University Hospital
Yamagata, Japan
Actively Recruiting
34
Keimyung University Dongsan Hospital
Daegu, South Korea
Actively Recruiting
35
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
36
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
37
Taichung Veterans General Hospital
Taichung, Taiwan
Actively Recruiting
38
National Cheng Kung University Hospital
Tainan, Taiwan
Actively Recruiting
39
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
40
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
C
Contact for Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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