ABCSG 50 / BRCA-P
Status: Treatment Phase & Follow-up
A randomized, double-blind, placebo-controlled, multi-center international phase III study to determine the preventive effect of Denosumab on breast cancer in women carrying a BRCA1 germline mutation
| Coordinating Investigator: | Christian Singer (Vienna) |
| Start of study: | 07/2019 (global und national) |
| Sample size: | 2.918 (international) |
| Sponsor (Austria): | ABCSG |
Description and status:
The prevention study ABCSG 50 / BRCA-P is an international phase III study to determine the effect of denosumab, a drug currently used to treat osteoporosis, on breast cancer in women carrying a BRCA1 germline mutation. The trial started in July 2019 and is conducted in 7 countries. Next to Austria, also Australia, Germany, Israel, Spain, the UK and the US are involved in this study. ABCSG is leading the study globally and is responsible for the international coordination, including the management of trial-related systems, such as central data management, as well as cooperation with local sponsors.
A total of 364 women were randomized into the study until the end of the enrollment phase on 31-Dec-2024, out of which 65 participants were included at Austrian sites. Patients are being treated with either denosumab or placebo every 6 months for a total period of 5 years.
This study is part of a comprehensive translational research program, not only evaluating the occurrence of breast cancer and triple negative breast cancer (TNBC), but also to determine the reduction in the risk of ovarian, fallopian and peritoneal cancers, and other malignancies, known to be associated with the germline BRCA1 mutation. Furthermore, many other endpoints and research questions, such as breast density and bone health, are being investigated.
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