CIBRAC Study

Principal Investigator

Mr Stuart McIntosh

Centre for Cancer Research and Cell Biology (CCRCB)

School of Medicine, Dentistry and Biomedical Sciences

Queen’s University Belfast

 

Name of the Study

-The full Study’s name and/or abbreviations for the Study title.

 CIBRAC: Chemoprevention in BRCA1 mutation carriers – a proof of concept study.

 

Why is this Study important?

Women with a BRCA1 gene mutation have a very high lifetime risk of developing breast and ovarian cancer. Currently, women wishing to reduce this risk are offered surgical removal of their breasts.

We are trying to develop a means of reducing this risk using drugs, to avoid the problems associated with surgery.

Data from our laboratory suggests that reducing levels of oestrogen in the blood and breast tissue may reduce the levels of damage to DNA within the cells of the breast (a key early event in breast cancers) and thus reduce the risk of developing breast cancer.

 

What is the Research question / aim?

- What does the Study test? 

This study aims to evaluate if the treatments that reduce oestrogen levels are tolerable and the effects are acceptable for women.  We will also examine whether reducing oestrogen levels using drugs can indeed reduce the amount of DNA damage in breast cells in BRCA1 mutation carriers. This may reduce the chances of developing breast cancer in these women.

Potentially this study may provide evidence to support a large scale clinical trial looking at the use of these drugs in women with a BRCA1 mutation to see whether their longer-term use might reduce the risk of developing breast cancer without requiring surgery. 

-How will patients / participants help in achieving this aim?

The potential participants are invited to the NICRF to meet with the coordinator who will explain the trial and take their consent.  Each consultation should last approximately one hour. 

Once consent is obtained, all further visits that involve study investigations, drugs or treatment will occur in Belfast City Hospital Outpatient department.

 

What the Study involves

-Attendance (Duration and number of visits):

The trial lasts 8 months and after consent is taken, requires 7 visits to Belfast City Hospital.

On the first day of the trial, participants will provide baseline breast biopsies, blood and urine samples, and complete a quality of life questionnaire.  Depending on which treatment arm they are allocated, they will then receive 3 months treatment with either:

goserelin (one injection per month) with anastrazole (one tablet per day)

or

tamoxifen (one tablet per day). 

At the end of the 3-months' treatment, they have repeat biopsies, blood and urine samples and questionnaires.  There is then a one-month period with no treatment before the participants receive the other treatment arm for a further three months, with a final set of biopsies, blood and urine samples and questionnaires at the end of treatment.  They will be reviewed one month after all treatment has finished, and that visit marks the end of the trial.

- Tests / questionnaires that the patients / participants will encounter:

At three points during the trial, participants will have samples taken.  These include breast core biopsies, which are performed under local anaesthetic with ultrasound guidance, blood samples and urine samples.  At the same times, participants will complete quality of life questionnaires.

 

PPI Involvement

The study was designed with input from BRCALink NI, the support group for women in Northern Ireland with a BRCA mutation, and ongoing engagement with this group will be critical to a successful study.

 

Who can take part in the Study?

- What, if any, are the specific eligibility criteria?

You can take part if you are a woman aged over 18 and you:

Have a BRCA1 gene mutation

Have not yet gone through the menopause

Have not had any risk reducing surgery (breast or ovarian)

Have not had any type of cancer

Are willing to use non-hormonal methods of contraception for duration of trial

Are not pregnant or breastfeeding

Do not have contraindications to study treatments or tests

 

Contact Information

Mr Stuart McIntosh

Email: s.mcintosh@qub.ac.uk

Phone number: 028 9097 2986

Social Media links: not applicable

Cancer Research UK Website: click here

 

Location:

NI Clinical Research Facility,

U Floor, Belfast City Hospital,

Lisburn Road, Belfast, BT9 7AB

 

Tel:+44 (0)28 9504 0342

Email:NICRF@belfastrust.hscni.net

 
Connect to the NICRF