Research from other important breast cancer clinical trials has confirmed how important it is that participants are followed up even after they have finished their medication. Results from the IBIS-I trial, which investigated tamoxifen to prevent breast cancer, showed that the incidence of breast cancer was reduced by 32% in women receiving tamoxifen compared to those taking placebo (dummy medication). Very importantly, these benefits extended beyond the treatment period, whilst most of the side effects did not.
Because of these findings participation in the IBIS-II trial in the “post-treatment follow-up phase” (that is after you have stopped taking your tablets) is vitally important. This includes anyone that decided to stop taking their medication before the full five year period. It will help us to find out more about the long-term benefits and side effects of anastrozole and tamoxifen, which will provide women in the future with more understanding about choosing the best treatment.
Participants do not need to attend clinic for follow-up visits in the post-treatment phase of the trial as this can be done by telephone from local sites or by postal questionnaire.
All IBIS-II participants are encouraged to maintain contact with their trial nurse and inform them of any change to contact details as well as any significant health events. In the UK, NHS registries are being used to supplement and confirm events reported by IBIS-II trial sites. Existing registries (Health & Social Care Information Centre http://www.hscic.gov.uk/) are providing data on cancer incidence and mortality. Further data are being collected via the Hospital Episode Statistics (HES) which utilises in-patient, out-patient and A&E data.
You are free to withdraw at any time from the study or long term follow up aspects of the trials. This will in no way effect the level of care you receive. However if you decide that we may have no further information from you for the study, it will not be possible to remove your data from analyses that has already been done.
Please contact your local IBIS-II trial nurse for further details on how to withdraw from the IBIS-II trial. Alternatively, you can request to withdraw from post-treatment follow-up questionnaires or further data collection by calling the IBIS-II Coordinating Centre on 020 7882 3838 or completing this form.