
“I had treatment last year and I want to give something back.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is for women who are at risk of developing breast cancer because they have the BRCA 1 gene change (mutation).
This study is open to women going to Family History clinics, BRCA clinics and the Higher Risk Breast Screening Programme in Northern Ireland.
For women with the BRCA 1 gene change (mutation) removal of their breasts (mastectomy) is the current treatment used to reduce their risk of developing breast cancer.
We know that removing the ovaries can also reduce the risk of breast cancer for these women.
The ovaries produce the female hormone oestrogen. By removing the ovaries the level of oestrogen in the body is reduced. Researchers think this might be the reason why removing the ovaries reduces the risk of breast cancer. But they aren’t certain.
Levels of oestrogen can also be reduced by the drugs:
Laboratory studies suggest that oestrogen can cause damage to the DNA in breast cells. This is a key early event in the development of breast cancer. So reducing the amount of damage to the breast cells could reduce the risk of breast cancer.
In this study women with the BRCA 1 gene change will have tamoxifen, anastrozole and goserelin.
The aims are to see:
The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
You may be able to join this study if you are a woman going to Family History clinics, BRCA clinics and the Higher Risk Breast Screening Programme in Northern Ireland and all of the following apply.
You cannot join this study if any of these apply. You
This is a pilot study. The study team need 12 women to join. Everyone taking part is put into 1 of 2 groups by a computer to decide which treatment they have first. The 2 groups are:
You have 12 weeks of treatment. You then have a month of no treatment. After this you switch over to the other treatment group for another 12 weeks.
Tamoxifen is a tablet you take once a day.
Anastrozole is a tablet you take once a day.
Goserelin is an injection you have under the skin every 4 weeks. It is a small implant placed under the skin on your tummy (abdomen). It dissolves slowly over 4 weeks. You have a total of 3 injections over the 12 weeks.
Quality of life
You fill in questionnaires:
The questions ask about:
These are called a quality of life questionnaires.
Samples
The study team take samples of breast tissue (biopsies) and will ask for blood and urine samples:
Sub study
This sub study is open to women who decided to join the study and women who declined to join. The team will invite between 10 and 15 women from each group to an attend an interview.
For women who joined the study they will ask about:
For women who declined to join the questions asked are about:
You see the doctor at the Belfast City Hospital 8 times during the study.
For the sub study the team will arrange the interview at a time and place convinent to you.
The side effects of tamoxifen, anastrozole and goserelin are similar to going through the change of life (menopause). These include:
You might have slight bleeding and bruising after the biopsies.
You doctor will talk to you about the side effects of treatment before you agree to take part.
We have information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Mr Stuart McIntosh
Cancer Research UK
Belfast Health & Social Care Trust
Experimental Cancer Medicine Centre (ECMC)
Queen's University Belfast
Northern Ireland Cancer Trials Network (NICTN)
Freephone 0808 800 4040
“I had treatment last year and I want to give something back.”