NRG-HN010 is a clinical study for people with salivary gland cancer that is considered HER2-positive in cases where the cancer has come back (recurrent), the cancer has spread outside of the salivary gland (metastatic), or the cancer cannot be removed through surgery (unresectable). Currently, patients with this type of cancer are treated with a chemotherapy drug called docetaxel and a drug that targets HER2-positive cancer cells called trastuzumab.
The purpose of this study is to compare the usual treatment of docetaxel and trastuzumab to ado-emtansine (T-DM1), a drug that targets HER-2 cancer cells and delivers chemotherapy to those cells.The use of ado-trastuzumab emtansine (T-DM1) in place of docetaxel and trastuzumab could stabilize your cancer, but it could also cause side effects. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach, ado-trastuzumab emtansine (T-DM1), extends the time without your cancer growing or spreading longer than the usual approach.
Docetaxel and trastuzumab are approved by the US Food and Drug Administration (FDA) for use in some types of cancers including those that are HER2-positive.Docetaxel and trastuzumab are used off-label as part of the usual care to treat recurrent or metastatic salivary gland cancer.Off-label means the drugs are not approved by the FDA for use in salivary gland cancer.Ado-trastuzumab emtansine (T-DM1) is approved for HER2-positive breast cancer but is not approved by the FDA for the treatment of salivary gland cancer.
More information about this particular study is located on ClinicalTrials.gov
If you over the age of 18 with HER2-positive salivary gland cancer that has come back, spread outside of your salivary gland, or cannot be removed by surgery, you may be able to participate. Your healthcare team is the best source for information about your treatment options, including cancer clinical trials. Be sure to take this information to your doctor to discuss your questions and concerns in general and specific to the NRG-HN010 study.
Are you interested in joining the study? Find a participating location
Additional information for the NRG-HN010 study can be found in the Patient Study Brochure. Download Brochure
Below, you can find FAQs about clinical research and this particular clinical trial.
Talk to your insurance provider and make sure that you understand what your insurance pays for and what it doesn’t pay for if you take part in this clinical trial. Also, find out if you need approval from your plan before you can take part in the study.
You or your insurance provider will not have to pay for ado-trastuzumab emtansine (T-DM1) while you take part in this study.
You will not be paid for taking part in this study.
Doctors and researchers conduct a clinical study, also called a “clinical trial,” to find better ways to prevent, diagnose, or treat an illness. NRG Oncology is supported by the National Cancer Institute (NCI) and runs clinical studies specifically for patients with cancer or to prevent cancer. Most clinical studies test something we know against something we don’t know. In all situations, these studies are strictly evaluated before they are allowed to be offered to any patient. The study is designed to answer the question that we do not know the answer to, so that current and future patients may have better treatments or information than what we currently have. There are different types of clinical studies that might be available for patients. For more information see “Types of Clinical Trials” and “Phases of Clinical Trials”.
Patients who volunteer to take part in a clinical study are followed closely by their health care professionals and members of the research team. For more information see “Research Team Members”.
At NRG Oncology, we focus on conducting clinical studies aimed to improve current cancer care practices and the lives of cancer patients. NRG Oncology partners with more than 1,300 member sites world-wide to research ways to improve treatment standards in the cancer community. Our organization is supported primarily through grants from the National Cancer Institute (NCI) and is one of five research groups in the NCI's National Clinical Trial's Network.