BRCA-P is the breast cancer prevention trial for BRCA1 carriers who have never had breast cancer. The study drug in this Phase III prevention trial, so the endpoint is breast cancer, the study drug is denosumab, which is a RANK ligand inhibitor. This is based on the work of Geoff Lindeman in Australia, showing that RANK ligand itself was important in the development of BRCA1-associated breast cancer, and therefore its inhibition should reduce risk...
BRCA-P is the breast cancer prevention trial for BRCA1 carriers who have never had breast cancer. The study drug in this Phase III prevention trial, so the endpoint is breast cancer, the study drug is denosumab, which is a RANK ligand inhibitor. This is based on the work of Geoff Lindeman in Australia, showing that RANK ligand itself was important in the development of BRCA1-associated breast cancer, and therefore its inhibition should reduce risk.
You can see in their primary publication by Nolan et al. that inhibition of RANK ligand blocks proliferation in animal models and in some early human tissue. The trial is open already in Austria, where it is led by Christian Singer through the ABCSG, Australia, Israel, Spain, Germany and the UK. The US is coming on board this summer.
We have a large grant for translational work to be part of the study. Hopefully this will change what we can offer women with BRCA1 mutations, at least to allow them to delay their consideration of prophylactic mastectomy, and hopefully permanently.