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

ConditionEndometrial Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDaiichi Sankyo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trastuzumab Deruxtecan

    Drug

    T-DXd will be administered at a dose of 5.4 mg/kg IV Q3W.

  • Chemotherapy

    Drug

    Carboplatin AUC 5 or 6 and paclitaxel will be administered at a dose of 175 mg/m2 Q3W, or carboplatin AUC 5 or 6 and paclitaxel 175 mg/m2 Q3W followed by chemoradiotherapy.

Treatment groups

710 Participants
are divided into 2 treatment groups
Group A: Arm A: T-DXdExperimental treatment 1 intervention
Group B: Arm B: Standard of Care ChemotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Disease-Free Survival as Assessed by Blinded Independent Central Review or by Histopathologic Confirmation of Disease Recurrence per Local Assessment

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

Time frame
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

Secondary outcomes

1

Overall Survival

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

Time frame
From randomization to the date of death due to any cause, up to approximately 63 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daiichi Sankyo

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov
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