IBIS 3 Feasibility version 1.0
Research type
Research Study
Full title
FEASIBILITY of IBIS 3. An International Breast Intervention Study investigating Prevention Of Late Recurrence in ER+ breast cancer survivors following 5 years of adjuvant treatment
IRAS ID
165266
Contact name
Sally Burtles
Contact email
Sponsor organisation
Joint Research and Development Office
Eudract number
2014-004430-26
ISRCTN Number
ISRCTN93764730
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
This feasibility study will assess recruitment and adherence to treatments for a large phase III clinical trial.
Late recurrence in women with hormonal breast cancer is a recognised problem, with recurrence rates remaining constant for at least 20 years following diagnosis. This study will investigate if three types of medicine can prevent breast cancer from returning. These are metformin, zoledronic acid and a group of medicines called aromatase inhibitors (anastrozole, letrozole or exemestane). The drugs are given separately or in combination with each other resulting in eight different treatment groups, including a ‘no continued treatment’ group which is current standard care.
Patients will be post- menopausal, hormonal breast cancer survivors who have already had 5 years of hormonal therapy (at least 4 years of treatment with an aromatase inhibitor) completed within the last 6 years. They must be without, but at increased risk of, a breast cancer recurrence (node positive, where tumour cells were found in the lymph glands OR tumour size greater than or equal to 2cm).
This study will assess the time and resources taken to recruit 300 eligible patients at 16 hospital sites. It will assess adherence to treatment, the feasibility of recruiting patients via GP surgeries and collecting questionnaire data from patients via email and post.
Screening and safety checks will take place on all patients before they join the study. They will receive a bone density scan to check for osteoporosis and provide blood samples to check kidney function and glucose levels. Bloods will be collected and stored for future analyses to identify women at high risk of recurrence and predictors of response to treatment.
Treatment is for 2 years with 6 monthly clinic visits. Side effects, health economics and quality of life questionnaires will take place at 3 monthly intervals.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/0833
Date of REC Opinion
8 Jun 2015
REC opinion
Further Information Favourable Opinion