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.
Be under 75 years old.
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
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
The study is being carried out at 18 UK hospitals:
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
Ninewells Hospital, Dundee
Borders General Hospital, Melrose
Western General Hospital Edinburgh
University Hospital LLandough, Cardiff
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.
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 firstname.lastname@example.org