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

Phase 3
Not yet recruiting
Conditions
Endometrial Cancer
Interventions
Registration Number
NCT07022483
Lead Sponsor
Daiichi Sankyo
Brief 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.

Detailed Description

This is a global, multicenter, open-label, phase 3 study to evaluate the efficacy and safety of T-DXd versus SoC chemotherapy with or without radiotherapy as adjuvant treatment in participants with HER2-expressing (IHC 3+/2+) endometrial cancer. Participants will be randomized 1:1 to either T-DXd or SoC chemotherapy. The primary objective will assess disease-free survival as assessed radiographically by BICR or by histopathologic confirmation of disease recurrence per local assessment.

T-DXd (Enhertu®) is a HER2 directed ADC composed of a humanized anti-HER2 IgG1 mAb with the same amino acid sequence as trastuzumab, which includes a plasma-stable, selectively cleavable linker and potent topoisomerase I inhibitor payload (a derivative of exatecan) that leverages the clinically validated DXd ADC technology.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Female
Target Recruitment
710
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Arm B: Standard of Care ChemotherapyChemotherapyParticipants will receive carboplatin AUC 5 or 6 and paclitaxel 175 mg/m2 Q3W, or AUC 5 or 6 and paclitaxel 175 mg/m2 Q3W with or without \[optional\] radiotherapy or chemoradiotherapy (EBRT plus cisplatin \[as radiosensitizer\] 50 mg/m2
Arm A: T-DXdTrastuzumab DeruxtecanParticipants will receive T-DXd 5.4 mg/kg intravenously (IV) once every 3 weeks (Q3W) with or without \[optional\] radiotherapy
Primary Outcome Measures
NameTimeMethod
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.

Secondary Outcome Measures
NameTimeMethod
Overall SurvivalFrom randomization to the date of death due to any cause, up to approximately 63 months

Overall Survival is defined as the time interval from the date of randomization to the date of death due to any cause.

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