An exciting international academic study is looking for participants.
The aim of the research is the prevention of breast cancer in women with a BRCA1 mutation, and the UK element of the study, headed by Professor Gareth Evans, will take place in Manchester.
In Europe and the USA, more than 1.3 million women are estimated to carry a mutation in the BRCA1 or BRCA2 genes. These women have up to 87% lifetime risk of developing breast cancer. Currently, surgery is the only proven procedure that significantly reduces breast cancer risk.
What is the BRCA1 study about?
This upcoming study, called BRCA-P, will test whether a drug called Denosumab can reduce the risk of breast cancer in women who carry a mutation in BRCA1.
Half of the women recruited will receive Denosumab whilst the other half will receive a placebo. The placebo is designed to look exactly like the Denosumab injection but has no active drug in it. The treatment is given every 6 months for five years and then participants will be followed for another 5 years after that. At the end of the study the researchers will then see whether fewer women who received the Denosumab developed breast cancers compared with those that received a placebo.
Currently, women who carry a BRCA1 gene mutation are monitored with checks that can include annual screening with mammography and/or MRI scans. These are very helpful to detect early, more manageable cancers but do not prevent breast cancer. The only currently proven way to prevent breast cancer is by removal of all breast tissue (‘bilateral mastectomy’), usually with breast reconstruction.
The BRCA-P clinical trial hopes to offer women a treatment option that could delay or even prevent the need for a mastectomy.
In addition to looking at the reduction in the risk of all breast cancers, the researches will also see whether the Denosumab treatment:
- Reduces the risk of triple negative breast cancer.
- Reduces the risk of ovarian cancers.
- Reduces the risk of other (i.e., non-breast and non-ovarian) cancers.
- Reduces the risk of clinical fractures.
The criteria to take part is as follows:
- Women with a confirmed or likely BRCA 1 mutation, and unaffected by breast or ovarian cancer.
- Aged 25-55.
- May be either pre or post-menopausal.
- You must not be pregnant or planning to get pregnant.
- Not planning to have preventive breast surgery (mastectomy).
- Not taking any breast cancer preventative agents such as Tamoxifen or an Aromatase Inhibitor.
Where will it take place exactly?
At the Clinical Research Facility, Wythenshawe Hospital. This is the research building just over the car park from The Nightingale Centre
How long will each treatment last?
The treatment is a very simple and small injection with the drug called Denosumab. This drug is actually licenced for the treatment of thin bones (osteoporosis) and is very well tolerated. Women only need to come for treatment every 6 months and the visits will take no more than an hour.
What happens if you choose to take part?
The researchers will send out an information sheet by email or in the post and then ask you to come to the clinic, sign the consent form and be screened for the study. Screening only takes a couple of hours and treatment can usually be started on the same day. Blood tests are required at screening, before each injection and two weeks after the first one. A bone density scan is also required before treatment starts and again at the end of the treatment period (5 years).
Are expenses covered?
If you would like to find out more and to be considered for this study, please email BRCAP@mft.nhs.uk to give the research team your details.