The BRCA-P Study is an international clinical trial for women who are born with a mutation (change) in one of their BRCA1 genes. Our main goal is to answer the question:

Can the study medication, denosumab, decrease the risk of developing breast cancer compared to a placebo (inactive substance) in women with a BRCA1 gene mutation?

Dr. Judy Garber, Chief of the Division of Cancer Genetics and Prevention at the Dana-Farber Cancer Institute and Principal Investigator for the BRCA-P study, talks about the study’s importance and its aims.

The BRCA-P Study is a “randomized trial,” meaning that women who consent to join will be randomly assigned by computer to receive either denosumab or a placebo (inactive substance) as a small injection under the skin every 6 months for the 5 years of the study. Neither the woman nor study staff will know which substance she is receiving, but it will be the same one throughout the study. See more details about study participation.

Denosumab

Denosumab is a medication approved by the FDA for treating osteoporosis (weakening of the bones) in healthy people. It is also approved for serious bone problems in people who have cancer that has metastasized (spread) to bone. Some common side effects of denosumab 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.

BRCA-P Study recruitment

The BRCA-P Study is enrolling nearly 3,000 women with a BRCA1 mutation from around the world. The study is open in more than 30 sites in the United States, as well as sites in Austria, Australia, Germany, Israel, Spain, and the United Kingdom.

We welcome and hope all eligible women will consider joining us, regardless of race, religion, color, or any other non-medical factor.

Your participation will help advance the latest breast cancer research for future generations! Join us to help make a difference.