Observational long-term follow up study of participants from the IBIS-II DCIS and Prevention clinical trials
Breast cancer prevention
Current interventions as of 09/04/2024: Long-term follow-up study of the IBIS-II DCIS (NCT00072462; ISRCTN37546358) and Prevention (NCT00078832; ISRCTN31488319) cohorts via NHS Digital. Data linked to the participants of the IBIS-II studies will be extracted annually from NHS Digital providing HES, Civil registration, and Cancer Registry datasets. This data will be analysed with existing IBIS-II data to identify new or recurrent breast cancers, other cancers, and cardiovascular and musculoskeletal events to understand the long-term effects of anastrozole in women with an increased risk of breast cancer. Follow-up is to continue until 2026, although the study may be extended. Previous interventions: Long-term follow-up study of the IBIS-II DCIS and Prevention cohorts via NHS Digital. Data linked to the participants of the IBIS-II studies will be extracted annually from NHS digital providing HES, Civil registration, and Cancer Registry datasets. This data will be analysed with existing IBIS-II data to identify new or recurrent breast cancers, other cancers, cardiovascular and musculoskeletal events to understand the long-term effects of anastrozole in women with an increased risk of breast cancer. Follow-up to continue until 2026, although the study may be extended.
1. Randomised to treatment in IBIS- II Prevention or DCIS studies 2. Participant was known to be alive at the point the study closed 3. Has given valid consent to participate in compliance with local and national requirements 4. Participant’s local IBIS-II study site is closed to the IBIS-II Prevention and DCIS CTIMP study protocols
1. Participant death has been reported to the study during their participation in the IBIS-II Prevention and DCIS CTIMP study 2. Participant has withdrawn consent to participate in IBIS-II Prevention and DCIS CTIMP studies 3. Participant has withdrawn consent to digital registry flagging in the IBIS-II Prevention and DCIS CTIMP study 4. Participant known to have emigrated