Testing the use of fulvestrant and binimetinib targeted treatment for NF1 mutation in hormone receptor-positive metastatic breast cancer

If you are over the age of 18 and have hormone receptor-positive metastatic breast cancer with NF1 mutation, you may be able to participate.

This study is being done to see adding the drug binimetinib to the drug fulvestrant for people with your type of cancer who have not previously received the drug fulvestrant will stabilize your cancer and lengthen the time that you live. If you have received fulvestrant before, this study will see if adding binimetinib will shrink your cancer within 4 months of starting treatment.

If you decide to take part in this study, you will either get the study drugs fulvestrant and binimetinib or fulvestrant alone if you never received fulvestrant (fulvestrant-naïve) in the past. You will get the study drugs fulvestrant and binimetinib if you have previously received fulvestrant (fulvestrant-exposed). Treatment will continue until your disease gets worse, or the side effects become too severe, or you decide to stop the therapy.

There is currently no agreed upon approach for treating cancers with the genetic change that you have (NF1). People who are not in a study are usually treated with hormonal therapy. Sometimes combinations of these are used. Treatments are generally continued until the disease gets worse or side effects become too severe. Your doctor can explain which treatment may be best for you. These treatments can reduce symptoms and may stop the tumor from growing for a few months or more. The usual approach is 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 approach may not be as good as the usual approach for your cancer. 
• The study approach 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 you have 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 the treatment with binimetinib and fulvestrant is effective in stabilizing your type of cancer if you are fulvestrant-naïve or shrinking your type of cancer if you are fulvestrant-exposed. It is not possible to know now if binimetinib and fulvestrant will extend how long you live with cancer and not have it get worse compared to the usual approach. This study will help the study doctors learn things that may help people in the future.

After you have completed fulvestrant and binimetinib or fulvestrant alone, your doctor and study team will continue to watch you for side effects, until your disease gets worse or the side effects become too severe. They will check you every 6 months for up to 5 years. This will be done at a visit to your study doctor. You will be in this study for up to 5 years from the time you join the study.

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 breast cancer. This includes:

• the cost of tests, exams, procedures, and drugs that you get during the study to monitor your safety, and prevent and treat side effects. 
• the cost of getting fulvestrant 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 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(TB). 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:

• The study sponsor and any company supporting the study drug now or in the future. This would include any organization helping the company with the study. 
• The NCI Central Investigational Review Board (IRB), which is a group of people who review the research with the goal of protecting the people who take part in the study. 
• The Food and Drug Administration (FDA) and the groups it works with to review research. 
• The NCI and the groups it works with to review research. 
• The NCI’s National Clinical Trials Network and the groups it works with to conduct research.

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".

• 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