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

Part of paid clinical trials in Fort Lauderdale, Florida.

Sponsor
Daiichi Sankyo
Study ID
NCT07022483
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 30, 2025
Status verified
May 2026
Primary completion
Mar 23, 2032
Completion
Mar 23, 2032

Study Design

Enrollment
710 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: T-DXd
    Participants will receive T-DXd 5.4 mg/kg intravenously (IV) once every 3 weeks (Q3W) with or without \[optional\] radiotherapy
  • Active Comparator: Arm B: Standard of Care Chemotherapy
    Participants 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

Primary Outcome Measure

Disease-Free Survival as Assessed by Blinded Independent Central Review 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 ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Broward Health Medical CenterFort LauderdaleFlorida33316-
Miami Cancer InstituteMiamiFlorida33176-
Mount Sinai Medical CenterMiami BeachFlorida33140-
Trials365 LLCShreveportLouisiana71103-
FirstHealth of the Carolinas, Inc.PinehurstNorth Carolina28374-
University of Cincinnati Physicians Group, LLCCincinnatiOhio45206-
Avera Medical Group Gynecologic Oncology Sioux FallsSioux FallsSouth Dakota57105-
Texas Oncology San Antonio Medical CenterSan AntonioTexas78240-

Find similar trials in Fort Lauderdale, FL

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Broward Health Medical Center· Fort Lauderdale, FLMiami Cancer Institute· Miami, FLMount Sinai Medical Center· Miami Beach, FLTrials365 LLC· Shreveport, LAFirstHealth of the Carolinas, Inc.· Pinehurst, NCUniversity of Cincinnati Physicians Group, LLC· Cincinnati, OH

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