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Study of Trastuzumab Deruxtecan for HER2-Expressing Endometrial Cancer

This study is looking at Trastuzumab Deruxtecan (T-DXd) compared to standard chemotherapy for people with HER2-expressing (IHC 3+/2+) endometrial cancer. T-DXd is a targeted drug that uses a special delivery system (ADC) to bring a cancer-fighting medicine directly to HER2-positive cells. You might be able to join if you are an adult woman with endometrial cancer that has not been treated with anti-cancer therapy before surgery, and your cancer shows HER2 expression. The main goal is to see if T-DXd can help you live longer without the cancer coming back (disease-free survival). The study plans to enroll 710 participants.

Study design
This is a global, multi-center, open-label Phase 3 study. Participants will be randomly assigned to receive either Trastuzumab Deruxtecan or standard chemotherapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the start of the study until the first sign of cancer recurrence or death, for up to approximately 51 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07022483

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Daiichi Sankyo
~710 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Trastuzumab DeruxtecanChemotherapy

At a glance

Recruiting sites
75 of 75 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-Free Survival as Assessed by Blinded Independent Central Review or by Histopathologic Confirmation of Disease Recurrence per Local Assessment
Measured over From randomization to the first documented local regional recurrence, distant metastasis, or death due to any cause, whichever occurs first, up to approximately 51 months

Conditions

Endometrial Cancer

Explore related trials

Endometrial CarcinomaERBB2 Gene

Where it's being run

75 sites across 19 states
China16
Japan14
Italy6
Spain6
Argentina5
Taiwan4
Florida3
Chile3

Who to contact

Contact for Trial Information
[email protected]
908-992-6400
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults ≥18 years at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old)
Has histologically confirmed diagnosis of epithelial endometrial carcinoma. All histology's are allowed except for sarcomas (carcinosarcomas are allowed).
Is newly diagnosed FIGO 2023 Stage IIC (including Stage IICmp53abn) or Stage III Note: FIGO 2023 Stage 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 includes disease with local and/or regional spread of the tumor of any histological subtype.
Has HER2-expression (IHC 3+/2+) per 2016 ASCO-CAP gastric cancer IHC scoring guidelines as confirmed by central laboratory testing.
Has adequate archived tumor tissue sample (sample from surgery is strongly recommended) available for assessment of HER2 status by central laboratory.

Exclusion

Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas are also not allowed.
Has recurrent or FIGO 2023 Stage IV
Has measurable residual tumor after surgery as determined by BICR assessment.
Is known to have a POLE mutation from an approved and/or validated local test, according to local regulations, if available
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.
Has a QTcF prolongation to \> 480 msec based on average of the SCR triplicate12-lead ECG. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the trial enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.) and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.
Has a history of (noninfectious) ILD/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at SCR.

What this trial measures

  • Disease-Free Survival as Assessed by Blinded Independent Central Review or by Histopathologic Confirmation of Disease Recurrence per Local AssessmentFrom randomization to the first documented local regional recurrence, distant metastasis, or death due to any cause, whichever occurs first, up to approximately 51 months

    Disease-Free Survival will be assessed radiographically by BICR or by histopathologic confirmation of disease recurrence per local assessment.