A study of tamoxifen, anastrozole and goserelin for women who have the BRCA 1 gene mutation (CIBRAC)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Other

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.

More about this trial

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:

if women with the BRCA 1 gene change are willing to have these drugs
what affect these drugs have on breast cells
how the drugs affect quality of life for these women

Who can enter

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 have the BRCA 1 gene change (mutation)
You have your ovaries
You are able to have the drugs used in this study
The researchers are able to take samples of tissue (biopsies) from your breasts
You are willing to use reliable contraception a month before starting treatment, during treatment and after treatment until your periods return
You are at least 18 years old

You cannot join this study if any of these apply. You

Have a BRCA 1 gene change of uncertain significance – your doctor can tell you if you have this
Have, or had, breast cancer or ovarian cancer
Have any other type of cancer
Are going through, or have gone through the menopause
Have had surgery to remove your breast or ovaries to reduce your risk of getting cancer
Have a date scheduled and confirmed for surgery to reduce your risk of getting cancer
Have had medication to reduce your risk of getting breast or ovarian cancer
Are having hormone therapy unless it was stopped more than a month before joining the study
Are pregnant or breastfeeding

Trial design

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:

tamoxifen
anastrozole and goserelin

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.

CIBRAC Study Diagram

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:

at the start of treatment
at the end of your first 12 weeks of treatment
at the end of your second 12 weeks of treatment

The questions ask about:

your general health and wellbeing
any side effects
how treatment has affected you sexually

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:

before you start treatment
at the end of your first 12 weeks of treatment
at the end of your second 12 weeks of treatment

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:

thier experience in taking part in CIBRAC
why they decided to take part
how the team could improve the study

For women who declined to join the questions asked are about:

why they decided not to join the study
their understanding of chemoprevention and the BRCA1 gene change
their thoughts and opinions about clinical trials and studies
their thoughts and experience of when asked to join the CIBRAC study
their reasons for not joining the study
how the study team could improve the process of asking women to join

Hospital visits

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.

Side effects

The side effects of tamoxifen, anastrozole and goserelin are similar to going through the change of life (menopause). These include:

hot flushes
changes to your periods or your periods stopping
itchy, dry vagina
discharge from the vagina
feeling sick
joint pain
headaches

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:

Recruitment start:

14/03/2017

Recruitment end:

10/07/2020

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

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Questions to ask your doctor about clinical trials

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Mr Stuart McIntosh

Supported by

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

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