The BRCA-P Study is being conducted at more than 30 sites across the United States. Contact us (Contáctenos) to learn more! Join us by contacting the study team at the site nearest to you.
We welcome all eligible women into the BRCA-P Study. You may be eligible to participate 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 currently pregnant or breastfeeding
- Have not had a mastectomy (removal of both breasts by surgery)
If you are eligible and decide to join the 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 year 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
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.
Note: We highly recommend undergoing a dental exam before you join the study and taking 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 some extra “sub-studies.” If you join a sub-study, you may be asked to:
- Fill out some “quality of life” questionnaires that are especially important for learning about your well-being and unexpected side effects
- Give blood for research
- Take a new bone density test that is highly sensitive to changes in bones
For more information about joining the study, contact the study team at the site closest to you.