Breast cancer related to BRCA1 gene mutation is the most dangerous type of breast cancer. The headlines about Angelina Jolie's double mastectomy brought the BRCA1 gene to the public's attention: 80% of carriers develop breast cancer over the course of their lives and 50% develop ovarian cancer. However, that could change in future – because of a preventive vaccine that is currently being tested in an international Phase III preventive study led by MedUni Vienna.
Up until now, the only method of prevention for women with a BRCA1 mutation was to perform a double mastectomy and to remove the ovaries. In around 25% of cases, these serious operations – especially breast removal and reconstruction – were associated with complications and problems, for example due to repeat operations and chronic pain. For the first time, denosumab – which is currently undergoing a final Phase III trial to establish its efficacy – now promises an alternative treatment, which would avoid the need for such radical measures. Denosumab is a drug with a very favourable side-effect profile and is generally well tolerated.
Osteoporosis drug to prevent BRCA1-related breast- and ovarian cancer
The human monoclonal antibody denosumab has hitherto been used very successfully to treat osteoporosis and, in addition to this, is already approved for the prevention of a specific type of bone metastasis. In a study conducted by the Austrian ABCSG study group, denosumab was given to patients to treat the osteoporosis that often occurs under anti-hormonal cancer therapy. Christian Singer, Head of MedUni Vienna's Breast Health Center and Head of the Genetics und Epigenetics Cluster of the Comprehensive Cancer Center (CCC) says: "What we found was that there was also a significant reduction in the number of recurrences and new cases, indicating that the preparation also has a preventive effect in breast cancer. In a further step, Josef Penninger was able to demonstrate the general preventive efficacy in BRCA1-related breast- and ovarian cancer." This finding was confirmed in further studies and the drug was shown to have a high level of efficacy.
Subcutaneous injection instead of mastectomy and oophorectomy
The international research project is being led by Christian Singer, who instigated and designed the study. "Vienna General Hospital on the Medical University of Vienna campus is one of four Austrian centres (Vienna, Graz, Innsbruck and Salzburg) where women can take part in the study. Vienna is also the first centre in the world to have recruited study participants," says Singer. It is expected that a total of 2,918 healthy women with a BRCA1 mutation will take part in the study, which involves Australia, Germany, Israel, Spain, the UK and the USA, as well as Austria. As part of the study, the participating women will be given a subcutaneous injection of denosumab every 6 months for a period of 5 years.
For the first time, the study offers a non-invasive alternative to women with BRCA1 mutation
The study entitled "ABCSG 50/BRCA-P" is being organised and conducted in Austria by the ABCSG (Austrian Breast & Colorectal Cancer Study Group), together with local sponsors. The prerequisites for participating in the study are as follows:
• women aged between 25 and 55,
• who have a BRCA1 mutation,
• are healthy at the time of recruitment for the study,
• and have not undergone prophylactic mastectomy.
Participation in the study is of particular interest to all those women who do not currently want to have a preventive mastectomy or for whom such an operation is out of the question. In principle, it will be possible for participants to become pregnant after discontinuing the trial medication and women who have already had their ovaries removed can also participate.
You can participate in the study immediately
Women who want to take part in the study can register immediately
• with MedUni Vienna (for Vienna) using telephone number: (01) 40400-28010 or by email: email@example.com
• or with the ABCSG (for Vienna, Graz, Innsbruck or Salzburg) using telephone number: (01) 408 92 30 or by email: firstname.lastname@example.org
It goes without saying that there is no charge for participating in the study.
Major international study from Austria
The study is one of the largest and most important medical studies led by Austria over the last few years. Because of its major global relevance, the study is receiving a massive amount of financial support, for example from the German Ministry of Science and Education, and the US Defense Department in the highest grant category of US$10 million.