How can I participate in the BRCA-P Study?
You can participate in the following ways:
- Join the study by contacting the study site nearest to you. You may be eligible to participate in the BRCA-P Study if you:
- Have a confirmed BRCA1 gene mutation (variant)
- Are 25 to 55 years old
- Do NOT have a history of breast or ovarian cancer
- Are not pregnant or breastfeeding
- Have not had a mastectomy (removal of both breasts by surgery)
What is expected of me if I join the study?
If you are eligible and decide to join the BRCA-P Study, you will be asked to:
- Have blood drawn annually for testing and research (up to 4 tablespoons)
- Have a small injection of denosumab or a placebo (inactive substance) under the skin every 6 months for 5 years
- Submit your mammogram when you enroll and after your first and second years in the study for the study team to evaluate your breast density
- Have regular follow-ups with your study doctor/medical team to check on your overall health and talk about any symptoms or side effects
- Have a dental exam to make sure you don’t have any infections in your mouth (denosumab can cause some dental side effects). If dental concerns are found, you may be asked to visit your dentist before enrolling in the study
- Follow up with your study doctor yearly for up to 5 years after you finish the study
- Take calcium and vitamin D supplements daily for 5 years
Note: We highly recommend undergoing a dental exam before you join the study and take Calcium and Vitamin D supplements while you are on the study. The study does not cover the costs of dental care and supplements. Please speak to your doctor if this presents an unusual hardship to you.
You may also be asked to consider:
- Joining optional quality-of-life sub-studies to help researchers learn more about your symptoms and your physical, mental, and social well-being. These sub-studies are optional, but choosing to join 1 or more sub-studies, as well as the main study will help researchers to learn even more about what it’s like to take denosumab and to choose medication instead of surgery to reduce breast cancer risk.
- Optional scans and tests that will help researchers for future studies
Where is the BRCA-P Study being conducted?
This is an international study being conducted at more than 30 sites across the United States. To find out if there is a site near you that is open for enrollment, visit our study sites page.
Are there any risks to participating in the BRCA-P Study?
There is a risk that denosumab may not be as good as the usual approach for preventing breast cancer (risk-reducing mastectomies). There is also a risk that you could have negative side effects from denosumab. Common side effects include muscle and bone pain, shortness of breath, and low levels of phosphate in the blood. If you decide to participate in our study, your study doctor will carefully evaluate if denosumab is right for you. Your study doctor will also follow the effects of denosumab on your health and will work with you to prevent and manage any side effects.
Please note that participation in this study is voluntary. You can choose to leave the study at any time.
Why can’t men participate?
Men with a BRCA1 mutation have a 4 to 6% lifetime risk of developing breast cancer compared to women with a BRCA1 mutation who have a 50 to 70% lifetime risk of developing breast cancer. To see any benefit of denosumab in men with a BRCA1 mutation, we would have to enroll thousands of men in this study, which is not feasible. Also, we have limited safety data for the impact of denosumab on men.
Why is the BRCA-P Study only for women with a BRCA1 gene mutation?
We have excellent data from research studies done in the laboratory and some limited data in women with BRCA1 mutations that a medication blocking RANK Ligand reduces breast cancer risk. However, we need a large study, like BRCA-P Study, to prove that denosumab will help reduce the risk of breast cancer in women with a BRCA1 gene mutation. So far, in the laboratory, other genes, including BRCA2, do not show the same possible cancer risk-reducing effects from denosumab.
Why is there an age limit on this study?
The BRCA-P Study is enrolling younger women because laboratory research has shown that denosumab is most effective in younger women who have not yet gone through menopause.
What are my choices if I decide not to take part in this study?
You may choose to have the usual approach described below, under “What is the usual approach to reduce the risk or prevent breast or ovarian cancer in a woman with a BRCA1 mutation?” You may choose to take part in a different research study, if one is available.
Can I leave the study after I have joined?
Yes, participation is always optional. You can leave the BRCA-P Study at any time. Please contact us if you want to leave the study so we can make sure to address any concerns you may have. Also, sometimes women who have been taking the study medication denosumab will need to take an additional medication at the end of the study for extra bone protection.
Where can I get more information?
You may visit the NCI website for more information about studies or general information about cancer. You may also call the NCI Cancer Information Service to get the same information at: 800-4-CANCER (800-422-6237).
A description of this clinical trial is available on www.ClinicalTrials.gov (NCT04711109), as required by U.S. law. You can search the website for more information or contact a site near you. You can also contact our BRCA-P Study team at email@example.com.