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)

Conditions

HER2-expressing endometrial cancer (IHC 3+/2+)

Brief summary

DFS is defined as time interval from the date of randomization to the first documented local-regional recurrence, distant metastasis, or death due to any cause, whichever occurs first. DFS will be assessed radiographically by BICR or by histopathologic confirmation of disease recurrence per local assessment.

Detailed description

OS is defined as the time interval from the date of randomization to the date of death due to any cause., DFS is defined as the time from randomization to the first documented local-regional recurrence, distant metastasis or death due to any cause, whichever occurs first. DFS will be assessed radiographically by investigator or by histopathologic confirmation of disease recurrence per local assessment., Distant metastatic recurrence is defined as recurrence outside of vagina, pelvis, or pelvic lymph nodes., Local recurrence is defined as recurrence in the vagina as assessed radiologically by BICR or by histopathologic confirmation of disease recurrence per local assessment, Regional recurrence is defined as recurrence in the pelvis or pelvic lymph nodes as assessed radiologically by BICR or by histopathologic confirmation of disease recurrence per local assessment, Incidence of TEAEs, SAEs, TEAEs associated with dose modifications, AESIs, TEAEs with death outcome, and changes from baseline in vital signs, clinical laboratory results, ECGs, ECHO/MUGA, and ophthalmologic assessments, Change from baseline and time to deterioration for the following PRO questionnaire: EORTC QLQ-C30 GHS/overall QoL, physical, Change from baseline and time to deterioration for the following PRO questionnaires: EORTC QLQ-EN24: Back and pelvic pain (ENBP), tingling/numbness (ENTN), muscular pain (ENM), Serum concentrations of T-DXd, total anti-HER2 antibody and DXd., ADA incidence: The proportion of participants having treatment-emergent ADA. Titer and nAb may be determined when ADA is positive.

Related papers

No related papers found yet.

Interventions

DRUGDocetaxel AqVida 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGDS-8201a

DRUGPaclitaxel Ribosepharm 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCarboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
DFS is defined as time interval from the date of randomization to the first documented local-regional recurrence, distant metastasis, or death due to any cause, whichever occurs first. DFS will be assessed radiographically by BICR or by histopathologic confirmation of disease recurrence per local assessment.	—

Secondary

Measure	Time frame
OS is defined as the time interval from the date of randomization to the date of death due to any cause., DFS is defined as the time from randomization to the first documented local-regional recurrence, distant metastasis or death due to any cause, whichever occurs first. DFS will be assessed radiographically by investigator or by histopathologic confirmation of disease recurrence per local assessment., Distant metastatic recurrence is defined as recurrence outside of vagina, pelvis, or pelvic lymph nodes., Local recurrence is defined as recurrence in the vagina as assessed radiologically by BICR or by histopathologic confirmation of disease recurrence per local assessment, Regional recurrence is defined as recurrence in the pelvis or pelvic lymph nodes as assessed radiologically by BICR or by histopathologic confirmation of disease recurrence per local assessment, Incidence of TEAEs, SAEs, TEAEs associated with dose modifications, AESIs, TEAEs with death outcome, and changes from base	—

Measure

Time frame

OS is defined as the time interval from the date of randomization to the date of death due to any cause., DFS is defined as the time from randomization to the first documented local-regional recurrence, distant metastasis or death due to any cause, whichever occurs first. DFS will be assessed radiographically by investigator or by histopathologic confirmation of disease recurrence per local assessment., Distant metastatic recurrence is defined as recurrence outside of vagina, pelvis, or pelvic lymph nodes., Local recurrence is defined as recurrence in the vagina as assessed radiologically by BICR or by histopathologic confirmation of disease recurrence per local assessment, Regional recurrence is defined as recurrence in the pelvis or pelvic lymph nodes as assessed radiologically by BICR or by histopathologic confirmation of disease recurrence per local assessment, Incidence of TEAEs, SAEs, TEAEs associated with dose modifications, AESIs, TEAEs with death outcome, and changes from base

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Countries

France, Germany, Greece, Italy, Poland, Portugal, Spain

Outcome results

None listed