You may be eligible to participate in the BRCA-P study if you:
- Are a woman who has 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 breast(s) by surgery)
You may also be asked to consider some optional studies.
If successful, our study could give BRCA1 mutation carriers a new option to reduce breast cancer risk without surgery.
Your participation may help us advance breast cancer research for your family and beyond!
If you are eligible and decide to join the BRCA-P study, you will be asked to:
- Have blood drawn while you are on the study for testing and research purposes (up to 4 tablespoons)
- Be given 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 see whether there is any change in 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
- Follow up with your study doctor yearly for up to 5 years after your last injection of denosumab or placebo
- Have a dental exam to make sure you don’t have any infections in your mouth (denosumab can cause some dental side effects, especially severe in women with active mouth infection). If dental concerns are found, you may be asked to visit your dentist before enrolling in the study
- As recommended by the study, take calcium (500 mg) and vitamin D (400 IU) supplements daily for 5 years. Calcium and vitamin D are recommended for general bone health, and particularly for those taking denosumab
The BRCA-P study can help researchers find a non-surgical way to reduce breast cancer risk in women with a BRCA1 mutation. Thank you for considering participation in this study. If you decide to think further about enrolling in the study, we can assure you that your participation will help advance the latest breast cancer research for future generations!
If you are interested in learning more about the study or have any questions, please contact a member of the local study site team. Feel free to refer friends and family members.