Phase II Study of Postoperative Ado-trastuzumab Emtansine T-DM1 with Chemoradiation for HER2-Positive Salivary Gland Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the study drug Ado-trastuzumab emtansine T-DM1 combined with standard chemoradiation in treating HER2-positive salivary gland cancer. This phase II study focuses on how well T-DM1 works to prevent cancer recurrence after surgery and its safety when used alongside radiation and chemotherapy. Participants will receive standard surgery followed by radiation and chemotherapy with added T-DM1 treatment. T-DM1 is given through an intravenous infusion once every three weeks at a set dose for up to one year. Radiation and chemotherapy are scheduled during the first three cycles, with radiation and chemotherapy administered on specific days within these cycles. After treatment, participants will be followed for two years. Throughout the study, participants will undergo screening, evaluations, and follow-up visits including tests of organ function, cardiac assessments, and blood work. Researchers will monitor disease-free survival over two years, adverse events, overall survival, and distant metastasis-free survival up to three years. The total participation includes treatment for about one year and follow-up for up to three years.

Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas