NRG-BR007, also known as the “DEBRA” trial, is a clinical study looking at safely reducing the use of breast radiation after lumpectomy for people with low-risk, early-stage breast cancer. The study is seeking to determine if, in comparison to the usual treatment of breast radiation and hormonal therapy, a more conservative treatment of hormonal therapy alone is as effective in women with low-risk, early-stage, hormone-sensitive breast cancer who have had a lumpectomy. The benefit of removing radiation therapy from the standard treatment would be to remove the side effects and additional treatment burden associated with radiation therapy (described in the FAQ section below).
More information about this study is located on ClinicalTrials.gov
If you have low-risk early-stage breast cancer that is sensitive to hormone treatment, have had a lumpectomy and have an Oncotype Dx Recurrence Score equal to or less than 18, you may be able to participate. If you have not yet received an Oncotype Recurrence Score, you may still be eligible to participate once the Oncotype Dx Recurrence Score is obtained. 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, both in general and specific to the DEBRA study.
Are you interested in joining the study? Find a participating location
Additional information for the DEBRA study can be found in the Patient Study Brochure Download Brochure
Below, you can find FAQs about clinical research and this particular clinical trial.
Who is this study for?
If you decide to take part in this study and you have a small tumor and negative lymph nodes in your armpit but do not have an Oncotype DX Recurrence score, then some of the tissue left over from your breast surgery or when you were initially diagnosed with cancer will be sent to have an Oncotype DX Recurrence score done. If the test shows that your Oncotype DX Recurrence Score is equal to or less than 18 and you meet all other study requirements, then you can join the study.
What is this study examining?
What are the possible treatments?
If you decide to take part in the study, you will be randomly assigned to one of two possible study groups. You will either be given the usual treatment of receiving radiation to the breast and taking a hormonal medicine for at least five years, or you will be given the study treatment, only taking a hormonal medicine for at least five years.
What is the most common way to treat my cancer?
If you choose to take part in this study, there is a risk that:
There is evidence that the hormone medicine alone after lumpectomy is effective againstyour type of hormone sensitive cancer. It is not possible to know if, comparedto the usual approach, the study approach will extend your time withoutdisease. This study will give the study doctors information that may help cancerpatients omit radiation in the future.
How long will I be in this study?
These checks will be completed during visits to your study doctor.
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.You and /or your insurance plan normally will need to pay for the Oncotype DX Recurrence Score testing. Exact Sciences will cover the cost of this test for patients with very small tumors that do not have an Oncotype DX Recurrence Score.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:
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”.
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.