Phase II Study of Targeted HER2 Treatments for Recurrent or Metastatic HER2-Positive and HER2-Low Salivary Gland Cancers

What this Trial Is About

Researchers are evaluating different treatments for patients with HER2-expressing salivary gland cancers that have returned, spread, or cannot be removed by surgery. This phase II trial compares the usual treatment of docetaxel chemotherapy combined with trastuzumab to a targeted therapy called ado-trastuzumab emtansine T-DM1 in patients with HER2-positive cancer. The study also tests how well trastuzumab deruxtecan works in patients with HER2-low expressing salivary gland cancer. These treatments target cancer cells by attaching to HER2 receptors and delivering chemotherapy directly to them. Patients with HER2-positive disease are randomly assigned to receive either docetaxel and trastuzumab or ado-trastuzumab emtansine intravenously every 21 days, with the option to switch treatments if the disease progresses. Patients with HER2-low expression receive trastuzumab deruxtecan intravenously every 21 days. Treatments continue as long as there is no disease progression or unacceptable side effects. Throughout the study, patients undergo imaging tests like CT, MRI, echocardiography, or MUGA scans, blood sample collections, and biopsies to monitor their disease and treatment effects. Participants are followed closely during treatment and then monitored every three months for two years, then every six months for an additional 3 to 5 years, and annually thereafter. Researchers assess how long patients live without their disease worsening, response rates to treatment, overall survival, side effects, and patient-reported symptoms. Blood and tissue samples are also collected for future research to understand how tumor characteristics affect treatment response. The total study duration may last several years to evaluate long-term outcomes and safety.

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