Informations générales (source: ClinicalTrials.gov)
A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy With or Without Radiotherapy as Adjuvant Treatment for HER2-Expressing (IHC 3+/2+) Endometrial Cancer (DESTINY-Endometrial02/ GOG-3122/ ENGOT-en30/GINECO)
Interventional
Phase 3
Daiichi Sankyo (Voir sur ClinicalTrials)
septembre 2025
mars 2032
28 octobre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Alexandra LEARY | 16/10/2026 17:45:04 | Contacter | ||
Critères
Femme
Key Inclusion Criteria
- 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+).
- Has adequate archived tumor tissue sample available for assessment of HER2 status by
central laboratory.
Key Exclusion Criteria
- 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 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.
- 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+).
- Has adequate archived tumor tissue sample available for assessment of HER2 status by
central laboratory.
Key Exclusion Criteria
- 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 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.