NRG-HN010: Comparing a Study Drug to the Usual Treatment for People with Metastatic HER2-Expressing Salivary Gland Cancer that Cannot be Removed by Surgery

If you over the age of 18 with HER2-expressing 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.

For patients with HER2-positive salivary gland cancer, this study will be comparing 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, to determine if ado-trastuzumab emtansine is better at extending the time your cancer does not grow or spread more than the usual treatment and without added side effects.

For patients with HER2-low salivary gland cancer, this study will test the good and bad effects of the drug called DS-8201a (trastuzumab deruxtecan), a drug that targets cancer cells that have low or high levels of HER2 protein and delivers chemotherapy to those cells. DS-8201a (trastuzumab deruxtecan) could shrink your cancer, but it could also cause side effects, which are described in the risks section below. The study doctors hope to learn if the study drug will shrink your tumors by at least 30% of its present size.

The usual approach for patients with HER2-positive salivary gland cancer who are not in a study is treatment with the chemotherapy drug, docetaxel, together with trastuzumab, a drug that targets HER2-positive cancer cells. There is no preferred treatment for HER2-positive salivary cancers, but the combination of docetaxel and trastuzumab has been the most extensively studied treatment in HER2-positive salivary cancer patients to date. There are no other treatments that are proven to help patients with your health condition live longer.

There is not a standard treatment approach for patients with HER2-low salivary gland cancer who are not in a study. Chemotherapy is often used. There are no treatments that are proven to help patients with your health condition live longer.

If you choose to take part in this study, there is a risk that:

• You may lose time at work or home and spend more time in the hospital or doctor’s office than usual. 
• You may be asked sensitive or private questions which you normally do not discuss. 
• The study drugs may not be as good as the usual approach for your cancer at shrinking or stabilizing your cancer and preventing your cancer from spreading. 
• The drugs used on this trial may cause side effects. Your doctor will review all of the potential side effects with you. It is important to tell your doctor about any side effects during the study so that they may be treated and so that potential adjustments to the study drugs may be made.

For HER2-positive salivary gland cancer, there is evidence that ado-trastuzumab emtansine (T-DM1) is effective in stabilizing your type of cancer. It is not possible to know now if the study approach will extend your time without your disease worsening compared to the usual approach.

For HER2-low salivary gland cancer, DS-8201a (trastuzumab deruxtecan) has shrunk or stabilized your type of cancer in a limited number of people. It is unlikely that it will work in everyone with your cancer or help you live longer.

This study will help the study doctors learn things that will help people in the future.

For both disease types and all study groups, after you finish treatment, your doctor will continue to follow your condition and watch you for side effects. They will check you every 3 months for 2 years after treatment, then every 6 months for 3 years, then once every year after that.

No. Taking part in this study is voluntary. You are free to choose to participate or not to participate. If you choose to participate in this study, you are able to leave the study at any time. If you decide not to take part in this study, your doctor will discuss other treatment options with you.

You and/or your insurance plan will need to pay for the costs of medical care you get as part of the study, just as you would if you were getting the usual care for your cancer.

This includes:

• The costs of tests, exams, procedures, and drugs that you get during the study to monitor your safety, and prevent and treat side effects. 
• The costs of docetaxel and trastuzumab drugs and administration. 
• The costs of getting ado-trastuzumab emtansine (T-DM1) or DS-8201a (trastuzumab deruxtecan ready and giving it to you. 
• Your insurance co-pays and deductibles. 

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) or DS-8201a (trastuzumab deruxtecan) while you take part in this study. 

You will not be paid for taking part in this study.

Your privacy is very important to us and the researchers will make every effort to protect it. Your information may be given out if required by law. For example, certain states require doctors to report to health boards if they find a disease like tuberculosis. However, the researchers will do their best to make sure that any information that is released will not identify you. Some of your health information and/or information about your specimens from this study will be kept in a central database for research. Your name or contact information will not be put in the database.

There are organizations that may inspect your records. These organizations are required to make sure your information is kept private, unless required by law to provide information. Some of these organizations are:

• NRG Oncology and any company supporting the study now or in the future. This would include any organization helping the company with the study. 
• The National Cancer Institute (NCI) Central Institutional Review Board, which is a group of people who review the research with the goal of protecting the people who take part in the study. 
• The FDA and the groups it works with to review research. 
• The NCI and the groups it works with to review research, including the Cancer Trials Support Unit (CTSU). 
• The NCI’s National Clinical Trials Network and the groups it works with to conduct research. 
• The NCI’s National Clinical Trials Network and the groups it works with to conduct research including the Imaging and Radiation Oncology Core (IROC).

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”.

Yes. They are exactly the same thing.

The care cancer doctors provide to cancer patients today is the direct result of clinical studies (also known as clinical trials) that were done in the past. Clinical studies give doctors and the treatment team information about what types of treatments work and what treatments do not work, in a number of different situations. Some studies focus on treating the cancer, others on preventing the cancer, and others on helping patients feel better or healthier during or after treatments. When you take part in a clinical study, you add to our knowledge about cancer and it may help improve cancer care for future patients. Clinical studies are available to patients with many types of cancer and at all stages of treatment. In some situations, the only way to get these new treatments is by joining a clinical study.

A clinical study may take place in many locations, such as:

A study is typically led by a principal investigator who is a doctor or other advanced health care professional. A clinical study is carried out by following a very specific plan known as the “protocol”. The protocol is designed so all patients in the study are treated as well as possible and in the same way. The protocol also provides rules for the doctors and clinical study staff to follow to keep patients safe and make sure the study is run in an ethical manner.

No, not at all. Participation in a clinical study is completely voluntary. For more information see “Deciding to Take Part in a Clinical Trial”. You are free to choose to participate or not to participate. If you choose to participate in a study, you may still decide to leave the study at any time. If you decide not to participate in a study, your doctor will discuss other treatment options with you. For more information see “Questions to Ask Your Doctor about Treatment Clinical Trials“.

• You may choose to have the usual treatment approach (known as “standard of care”)
• You may choose to take part or learn more about a different study, if one is available
• You may choose not to be treated for cancer