IBIS 3 Feasibility Study

What is the purpose of this trial?

ibis3 trial backgroud

To find out the best way to prevent late breast cancer returning, we are testing three types of medicines. These are metformin, zoledronic acid and a group of medicines called aromatase inhibitors (anastrozole, letrozole or exemestane).The IBIS 3 Feasibility Study is investigating the prevention of late breast cancer recurrence and we are looking to recruit breast cancer survivors.

The medicines are given separately or in combination with each other resulting in eight different treatment groups, including a ‘no continued treatment’ group.

This is a ‘feasibility study’, which means we want to determine the possibility of recruiting participants to a larger IBIS 3 study. In particular we want to find out:

Whether the women we would like to take part will actually want to join
How long it will take us to recruit the number of women we need to be able to answer our research questions
Whether there are any issues with taking the medications
If we need to change anything about how the main trial will be organised

Women who take part will be expected to attend six monthly clinic visits with a specialist breast care team during the 2 year treatment period. All participants will receive appropriate screening and health checks, and any concerns can be discussed.

Am I eligible to join this study?

You Must...

 Be under 75 years old.
Be post-menopausal.
Have had previous breast cancer treated by surgery
Have had hormonal drug treatment for 5 years completed within the last 6 years
Have had node positive breast cancer (spread to lymph nodes) and/or tumour size was ≥ 2cm

You Must Not....

Have any recurrence or clinical suspicion of active breast cancer
Have any other previous cancer in the past 5 years (except non-melanoma skin cancer or in situ cancer of the cervix)
Using (or intending to use) oestrogen-based hormone therapy (HRT)
Have Type 2 diabetes AND osteoporosis
Have Type 1 diabetes

Where is the research taking place?

The study is being carried out at 18 UK hospitals:

England

Barts Hospital, London
Southmead Hospital, Bristol
University Hospital of South Manchester
Royal Oldham Hospital, Oldham
Weston Park Hospital, Sheffield
Princess Alexandra Hospital, Epping
Poole Hospital Foundation Trust, Dorset
St James’s University Hospital, Leeds
Pinderfields General Hospital, Wakefield
Royal Marsden Hospital, London
Charing Cross Hospital, London
Macclesfield District General Hospital, Cheshire
North Tyneside General Hospital, North Shields
Royal United Hospitals, Bath

Scotland

Ninewells Hospital, Dundee
Borders General Hospital, Melrose
Western General Hospital Edinburgh

Wales

University Hospital LLandough, Cardiff

Who is funding and organising this study?

Queen Mary University of London is organising this research and is the sponsor. Cancer Research UK (CRUK) and the Australia and New Zealand Breast Cancer Trials Group (ANZBCTG) are funding this study.

Who do I contact to find out more?

If you have any questions about the study or you are interested in taking part please contact Jill Knox on 020 7882 3510 or send an email to ibis3help@qmul.ac.uk