OncoMatch/Clinical Trials/NCT07022483
Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer
Is NCT07022483 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Trastuzumab Deruxtecan and Chemotherapy for endometrial cancer.
Treatment: Trastuzumab Deruxtecan · Chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Endometrial Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+/2+ per 2016 ASCO-CAP gastric cancer IHC scoring guidelines) (IHC 3+/2+)
Has HER2-expression (IHC 3+/2+) per 2016 ASCO-CAP gastric cancer IHC scoring guidelines as confirmed by central laboratory testing.
Excluded: POLE mutation
Is known to have a POLE mutation from an approved and/or validated local test, according to local regulations, if available
Disease stage
Required: Stage FIGO 2023 STAGE IIC, FIGO 2023 STAGE IICMP53ABN, FIGO 2023 STAGE III (FIGO 2023)
Excluded: Stage FIGO 2023 STAGE IV
Grade: high-grade EECs (grade 3)
Is newly diagnosed FIGO 2023 Stage IIC (including Stage IICmp53abn) or Stage III ... Has recurrent or FIGO 2023 Stage IV
Demographics
Prior therapy
Lab requirements
Cardiac function
No medical history of MI within 6 months before randomization/enrollment, no symptomatic CHF (NYHA Class II to IV), troponin above ULN at screening requires cardiologic consultation to rule out MI
Has a medical history of MI within 6 months before randomization/enrollment, symptomatic CHF (NYHA Class II to IV). Participants with troponin levels above ULN at SCR (as defined by the manufacturer), and without any MI related symptoms should have a cardiologic consultation during SCR Period to rule out MI.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mount Sinai Medical Center · Miami Beach, Florida
- Trials365 LLC · Shreveport, Louisiana
- Avera Medical Group Gynecologic Oncology Sioux Falls · Sioux Falls, South Dakota
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07022483 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 overexpression (IHC 3+/2+ per 2016 ASCO-CAP gastric cancer IHC scoring guidelines) is a required biomarker for enrollment.
Are patients with POLE alterations eligible?
No. POLE mutation is an exclusion criterion.
What disease stage is eligible?
Stage FIGO 2023 STAGE IIC or FIGO 2023 STAGE IICMP53ABN or FIGO 2023 STAGE III is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify