Testing the usual treatment of radiation therapy and HER2-targeted therapy to HER2-targeted therapy alone for low-risk HER2-positive breast cancer

This study is for women who meet the following criteria:

• have low-risk, HER2-positive breast cancer
• have undergone breast-conserving surgery, chemotherapy, and HER2-targeted therapy

The study doctors will be looking to see if HER2-targeted therapy without radiation has the same chance of preventing the breast cancer returning compared to HER2-targeted therapy with breast radiation.

If you decide to take part in this study, you will either have radiation therapy to the breast for 1-6 weeks or you will forego radiotherapy.

Your doctor and study team will continue to follow your condition for 10 years and watch you to see if your breast cancer comes back. They will check you three months after starting the study, after the last dose of radiation if you are in the group who receives radiation, and then every six months for the next 2 years. After that, they will check you every year for 8 years. This will be done at a visit to your study doctor. You will be in this study for about 10 years.

The usual approach for patients who have undergone breast conserving surgery (i.e., “lumpectomy”), chemotherapy, and HER2-targeted therapy and are not in a study is treatment with radiation therapy to the breast and continuing HER2-targeted therapy. Radiation therapy can be given to part or all of the breast delivered over 1-6 weeks. Your doctor can explain which breast radiation treatment method may be best for you. For patients who get the usual approach for this cancer, about 95 out of 100 are cancer free after 5 years.

If you choose to take part in this study, there is a risk that the study approach may not be as good as the usual approach for preventing your cancer from coming back.You also may have the following discomforts:

• Spend more time in the hospital or doctor’s office.

• Be asked sensitive or private questions about things you normally do not discuss.

• May not be able to take part in future studies.

The radiation treatment or the HER2-targeted therapy used in this study could be very harmful to an unborn or newborn baby. There may be some risks that doctors do not yet know about. It is very important that you check with your study doctor about what types of birth control or pregnancy prevention to use during the study and for up to 2 months after you have completed radiation therapy and for 7 months after you have completed HER2-targeted therapy.

The radiation treatment or the HER2-targeted therapy used in this study may affect how different parts of your body work such as your liver, kidneys, heart, and blood. The study doctor will test your blood and let you know if changes occur that may affect your health.There is also a risk that you could have other side effects from the radiation treatment or the HER2-targeted therapy.You can ask your study doctor questions about side effects at any time.

There is evidence that not giving radiation therapy may avoid the potential short-term and long-term risks of radiation. It is not possible to know now if the study approach will extend your time without disease compared to the usual approach. This study will help the study doctors learn things that will help people in the future.

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 costs 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 the HER2-targeted therapy ready and giving it to you.
• the cost of getting the radiation therapy if you are in Arm 1.
• 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 does not 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.

Ask your doctor or nurse for help finding the right person to talk to if you are unsure which costs will be billed to you or your insurance provider.

Taking part in this study may mean that you need to make more visits to the clinic or hospital than if you were getting the usual approach to treat your cancer. You may:

• Have more travel costs.
• Need to take more time off work.
• Have other additional personal costs.

You will not be paid for taking part in this study. The research may lead to new tests, drugs, or other products for sale. If it does, you will not get any payment.

Your privacy is very important to us. The study doctors will make every effort to protect it. The study doctors have a privacy permit to help protect your records if there is a court case. However, some of your medical information may be given out if required by law. If this should happen, the study doctors will do their best to make sure that any information that goes out to others will not identify who you are.

Some of your health information, such as your response to cancer treatment, results of study tests, and medicines you took, will be kept by the study sponsor in a central research database. However, your name and contact information will not be put in the database. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.

There are organizations that may look at or receive copies of some of the information in your study records. Your health information in the research database also may be shared with these organizations. They must keep your information private, unless required by law to give it to another group.

Some of these organizations are:

• The study sponsor (NRG Oncology).
• The NCI Central 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 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 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:

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