Testing the use of neratinib or the combination of neratinib and palbociclib targeted treatment for HER2+ gynecologic and other solid tumors

If you are over the age of 18 and have recurrent or persistent cancer, and your cancer expresses a protein called HER2, you may be able to participate.

This study is being done to determine if the combination of neratiniband palbociclib be more effective in delaying growth and/or spread of yourcancer than neratinib alone. Researchers want to find out if neratinib withpalbociclib is better than neratinib alone.

If you decide to take part in this study, you will eitherget the drug neratinib alone until your disease worsens or you haveunacceptable side effects, or you will get the drugs neratinib and palbociclibuntil your disease gets worse or you have unacceptable side effects. If youhave been getting neratinib alone and your disease gets worse, you can discusswith your doctor the option to crossover and get the combination of neratiniband palbociclib until your disease gets worse or you have unacceptable sideeffects.

There is currently no universal agreed upon approach for treating cancers with the genetic changes that you have, HER2 expressing cancer. People who are not in a study are usually treated with radiation, or drugs such as chemotherapy, HER2 targeted therapy such as neratinib or other therapies. Sometimes combinations of these are used and your doctor can explain which may be best for you. These treatments can reduce symptoms and may stop the tumor from growing for several months or more. Palbociclib has been approved by the FDA for certain types of breast cancer.

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 during the study so that they may be treated and so that potential adjustments to the study drugs may be made. 

There is some evidence that neratinib and palbociclib in combination can shrink or stabilize cancers that over-express a specific biomarker called HER2. It is not possible to know now if the study approach will shrink or stabilize your cancer.  This study is designed to answer this question.  This study may help the study doctors learn things that may help other people in the future.

After you finish your study treatment, your doctor and study team will continue to follow your condition every 3 months for up to two years to assess survival. Further visits may be scheduled depending on your recovery from side effects.

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.
• 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. 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 now or in the future. This would include any organization helping the company with the study.
• The National Cancer Institute (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 & 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, including NRG Oncology..

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