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NCT04620187
Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas
This research is being done to see how safe and effective the use of the study drug Ado-trastuzumab (T) emtansine (DM1), T-DM1, and standard of care chemoradiation are when used together in treating HER2-positive salivary gland cancer. It will also examine the effectiveness of study drug Ado-trastuzumab (T) emtansine (DM1) on cancer recurrence.
Trial Details
NCT ID NCT04620187 Phase PHASE2
Sponsor Dana-Farber Cancer Institute
Status RECRUITING
Cancer Type Salivary Gland Head and Neck Cancer
Interventions Ado-trastuzumab (T) emtansine (T-DM1) Standard of Care Radiotherapy Standard of Care Chemotherapy Locations (sample) Atlanta, Georgia, United States|33.749,-84.38798 Chicago, Illinois, United States|41.85003,-87.65005 Boston, Massachusetts, United States|42.35843,-71.05977 Boston, Massachusetts, United States|42.35843,-71.05977 Basking Ridge, New Jersey, United States|40.70621,-74.54932
Key Eligibility Criteria
Subject must have histologically or cytologically confirmed, resectable stage II (with positive margins), III, IVA, or IVB locoregionally advanced … Willing to provide tissue from a diagnostic biopsy or at the time of cancer resection, and blood samples before, during, and after treatment. HER2 positive disease as defined by any of the following: Tumor HER2 expression staining intensity of 2 or 3+ by IHC (from either a preoperative biopsy or resection specimen at the time of oncologic surgery) For full eligibility, visit ClinicalTrials.gov .