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

StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Minor Study completion pushed from Jul 31, 2032 to Jul 31, 2033 Show 5 more changesShow less
    • Study sites: 152 to 154
    • Eligibility criteria expanded, about 52 words
    • Secondary endpoints: details revised at 5 of 9 entries
    • Study description revised
    • Publications: details revised at 1 of 1 entry
  2. Minor Study completion pushed from Jul 31, 2028 to Jul 31, 2032v19
  3. Minor Study sites: 150 to 152v18
  4. Minor Site details revised at 2 of 150 sitesv17
  5. Minor Study sites: 148 to 150v16
Show 14 earlier versionsHide 14 earlier versions
  1. Minor Study sites: 143 to 148v15
  2. Minor Study sites: 132 to 143v14
  3. Minor Study sites: 120 to 132v13
  4. Minor Site details revised at 8 of 120 sitesv12
  5. Minor Study sites: 119 to 120
    • Interventions: Biopsy (Procedure), Biospecimen Collection (Procedure), Computed Tomography (Procedure), Docetaxel (Drug), Echocardiography (Procedure)… to Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Computed Tomography (Procedure), Docetaxel (Drug), Echocardiography Test…
    v11
  6. Notable Start date: Sep 30, 2022 to Mar 3, 2023v10 Show 9 more changesShow less
    • Primary endpoints: 1 to 2
    • Enrollment target: 116 to 146
    • Interventions: Docetaxel (Drug), Questionnaire Administration (Other), Trastuzumab (Biological), Trastuzumab Emtansine (Biological) to Biopsy (Procedure), Biospecimen Collection (Procedure), Computed Tomography (Procedure), Docetaxel (Drug), Echocardiography (Procedure)…
    • Eligibility criteria expanded, about 282 words
    • Secondary endpoints: 6 to 9
    • Study description expanded, about 287 words
    • Site details revised at 1 of 119 sites
    • Study arms: 2 to 3
    • Study title expanded, about 3 words
  7. Minor Site details revised at 5 of 119 sitesv9
  8. Minor Study sites: 110 to 119v8
  9. Minor Study sites: 92 to 110v7
  10. Minor Study sites: 80 to 92v6
  11. Minor Study sites: 77 to 80v5
  12. Minor Study sites: 62 to 77v4
  13. Minor Study sites: 1 to 62v3
  14. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 10, 2022 to Sep 30, 2022
    • Secondary endpoints: details revised at 6 of 6 entries
    • Primary endpoint revised
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
67 trials monitored
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This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-positive 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 (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by body's immune system. Trastuzumab emtansine contains trastuzumab, linked to a chemotherapy drug called emtansine. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers emtansine to kill them. Trastuzumab deruxtecan is a monoclonal antibody called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors and delivers deruxtecan to kill them. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Trastuzumab emtansine may work better compared to usual treatment of chemotherapy with docetaxel and trastuzumab or trastuzumab deruxtecan in treating patients with recurrent, metastatic or unresectable salivary gland cancer.
Trial Details
NCT Number NCT05408845
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)
Metastatic Salivary Gland Carcinoma, Recurrent Salivary Gland Carcinoma, Stage III Major Salivary Gland Cancer AJCC v8, Stage IV Major Salivary Gland Cancer AJCC v8, Unresectable Salivary Gland Carcinoma
Related terms Salivary Gland Neoplasms
Enrollment 146 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov