Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers

This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-postive salivary gland cancer that has come back (recurrent), that has spread from where it first started (primary site) to other places in the body, or cannot be removed by surgery (unresectable). This trial is also testing how well trastuzumab deruxtecan works in treating patients with HER2-low recurrent or metastatic salivary gland cancer. Trastuzumab is a form of targeted therapy because it works by attaching itself to specific molecules (rec

Trial Details

NCT ID
NCT05408845
Phase
PHASE2
Sponsor
NRG Oncology
Status
RECRUITING
Cancer Type
Salivary Gland Head and Neck Cancer
Interventions
  • Biopsy Procedure
  • Biospecimen Collection
  • Computed Tomography
  • Docetaxel
  • Echocardiography Test
  • Magnetic Resonance Imaging
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Duarte, California, United States|34.13945,-117.97729
  • Sacramento, California, United States|38.58157,-121.4944
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Atlanta, Georgia, United States|33.749,-84.38798

Key Eligibility Criteria

  • Pathologically (histologically or cytologically) proven diagnosis of HER2-positive OR HER2-low expressing recurrent/metastatic salivary gland cance…
  • HER2-positive cohort:
  • Note: The majority of HER2-positive SGCs are salivary duct carcinoma (SDCs), but to a lesser extent, other SGC subtypes can be HER2-positive (e.g.,…
  • Note: HER2 evaluation based on local site immunohistochemistry (IHC), fluorescent in-situ hybridization (FISH), or local/commercial next-generation…

For full eligibility, visit ClinicalTrials.gov.

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