To find out the best way to prevent late breast cancer returning, we were testing three types of medicines. These were metformin, zoledronic acid and a group of medicines called aromatase inhibitors (anastrozole, letrozole or exemestane).The IBIS 3 Feasibility Study was investigating the prevention of late breast cancer recurrence. We closed to recruitment on 26th September 2017.
The medicines were given separately or in combination with each other resulting in eight different treatment groups, including a ‘no continued treatment’ group.
This was a ‘feasibility study’, which means we wanted to determine the possibility of recruiting participants to a larger IBIS 3 study. In particular we wanted 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 are taking 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.
Been Under 75 years old.
Had previous breast cancer treated by surgery
Had hormonal drug treatment for 5 years completed within the last 6 years
Had node positive breast cancer (spread to lymph nodes) and/or tumour size was ≥ 2cm
Had any recurrence or clinical suspicion of active breast cancer
Had any other previous cancer in the past 5 years (except non-melanoma skin cancer or in situ cancer of the cervix)
Have been using (or intending to use) oestrogen-based hormone therapy (HRT)
Had Type 2 diabetes AND osteoporosis
Had Type 1 diabetes
The study was being carried out at 13 UK hospitals:
Barts Hospital, London
University Hospital of South Manchester
Weston Park Hospital, Sheffield
Poole Hospital Foundation Trust, Dorset
Pinderfields General Hospital, Wakefield
Charing Cross Hospital, London
Macclesfield District General Hospital, Cheshire
North Tyneside General Hospital, North Shields
Doncaster Royal Infirmary, Doncaster
Ninewells Hospital, Dundee
Borders General Hospital, Melrose
Western General Hospital Edinburgh
University Hospital LLandough, Cardiff
Queen Mary University of London was organising this research and was also the sponsor. Cancer Research UK (CRUK) and the Australia and New Zealand Breast Cancer Trials Group (ANZBCTG) are funding this study.