IBIS 3 Feasibility Study

** This study closed to recruitment on 26th September 2017 **

What was the purpose of this trial?

ibis3 trial backgroud

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.

Was I eligible to join this study?

You Must Have...

  Been Under 75 years old.
  Been post-menopausal.

  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

You Must Not Have....

 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

Where was the research taking place?

The study was being carried out at 13 UK hospitals:

England

  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

Scotland

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

Wales

University Hospital LLandough, Cardiff

Who was funding and organising this study?

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.

Who do I contact to find out more?

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