Trastuzumab Deruxtecan for the Treatment of HER2+ Newly Diagnosed or Recurrent Osteosarcoma
A Phase 2 Study of DS-8201a (NSC# 807708) in Adolescents, or Young Adults With Recurrent HER2+ Osteosarcoma
Sponsor: National Cancer Institute (NCI)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Event-free survival of DS-8201A for HER2+ osteosarcoma
Time frame: At 24 weeks
Secondary Endpoints
Incidence of adverse events of DS-8201A for HER2+ osteosarcoma
Time to progression of DS-8201A for HER2+ osteosarcoma
Overall survival of DS-8201A for HER2+ osteosarcoma
Eligibility Criteria
Inclusion Criteria: * Patients must be \> 12 years and =\< 39 years of age at the time of study enrollment * Patients must have had histologic verification of osteosarcoma at original diagnosis or relapse * Patients with diagnoses of osteosarcoma and confirmed HER2 expression of \> 10% of osteosarcoma cells are eligible for the intervention * Note: There is a mandatory tissue submission for HER2 staining during the Step 0 Eligibility Screening process. Metastatic tissue, when possible from the most recent relapse, is strongly preferred for HER2 staining over archival tissue from primary resection or diagnostic biopsy. The evaluation period for HER2 staining to determine eligibility for therapy will be less than 4 weeks from screening enrollment * Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Patients with clinically inactive brain metastases may be included in the study. Patients with treated brain metastases that…
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