Comparing a study drug to the usual treatment for people with metastatic HER2-positive salivary gland cancer that cannot be removed by surgery


Currently Available for Patients

 

About This Study

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 

 

 

Am I eligible for this study?

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 there other studies for which I might be eligible?

Please talk to your healthcare team to see if there are other clinical studies for which you may be a good fit.Click here if you would like to view a more detailed chart of other studies available.

 

Find a Study Location

Are you interested in joining the study? Find a participating location

 

Want more information?

Additional information for the NRG-HN010 study can be found in the Patient Study Brochure. Download Brochure


Untitled638001463267911790

Frequently Asked Questions

Below, you can find FAQs about clinical research and this particular clinical trial.

The NRG-HN010 Study FAQ

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.
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.
If you decide to take part in the study, you will be assigned to one of two possible study groups.


Patients in Study Group 1 will receive docetaxel and trastuzumab (TH) which is the usual treatment your type of cancer. If you are in Group 1 and have been receiving the usual treatment of docetaxel and trastuzumab for your type of cancer, but your tumor has grown, then the usual treatment for your cancer if it progresses is to receive a different chemotherapy drug and/or HER2 targeting drug. You do have the option to begin treatment with the study drug ado-trastuzumab emtansine (T-DM1).


Patients in Study Group 2 will receive the study drug, ado-trastuzumab emtansine (T-DM1). If your tumor grows on treatment with ado-trastuzumab emtansine (T-DM1), then the usual treatment for your cancer if it progresses is to receive a different chemotherapy drug and/or HER2 targeting drug. You do have the option to begin treatment with docetaxel and trastuzumab (TH).
The usual approach for patients 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.
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.
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. This study will help the study doctors learn things that will help people in the future.
If you are in Study Group 1 receiving docetaxel and trastuzumab, you will receive this treatment for 18 weeks. You will get trastuzumab longer, with or without docetaxel, if your doctor decides that you should continue. Treatment will stop when your disease gets worse, or the side effects become too severe.


If you are in Study Group 2 receiving ado-trastuzumab emtansine (T-DM1), you will continue to receive this treatment until your disease gets worse or the side effects become too severe.


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) 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) 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).

Clinical Studies FAQ

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:

  • physician offices
  • hospitals
  • clinics


  • 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".

    If you decide not to take part in a clinical study, you still have other choices. Talk to your doctor about your other choices.For example:

    • 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

    About NRG Oncology

    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.