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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 (May 2026). This Phase 3 trial studies multiple treatments including Trastuzumab Deruxtecan and Chemotherapy for endometrial cancer.

Phase 3RecruitingDaiichi SankyoNCT07022483Data as of May 2026

Treatment: Trastuzumab Deruxtecan · ChemotherapyThis 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.

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Extracted eligibility criteria

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

Prior therapy

No prior treatment (treatment-naive required)

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 →

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