IBIS-II-O: Observational long-term follow up study of participants from the IBIS-II DCIS and Prevention clinical trials of drugs for breast cancer prevention
| ISRCTN | ISRCTN17443780 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17443780 |
| IRAS number | 258590 |
| Secondary identifying numbers | IRAS 258590 |
- Submission date
- 14/10/2021
- Registration date
- 15/11/2021
- Last edited
- 09/04/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
The IBIS-II-O study tracks the long-term medical outcomes of 3000 + UK women who took part in the main IBIS-II clinical trials (Prevention [ISRCTN31488319], DCIS [ISRCTN37546358]) between 2004 and 2021. These studies looked at the breast cancer-preventive effect of anastrozole in women at increased risk of breast cancer. The women either took anastrozole compared with either tamoxifen (IBIS-II DCIS) or anastrozole compared with a placebo (IBIS-II Prevention) for 5 years and were then followed up for a further 5 years.
Results of IBIS-II DCIS and Prevention show that anastrozole significantly reduces the risk of developing breast cancer in these groups and that the effect continues for many years afterwards. IBIS-II-O uses data from NHS digital to track incidences of new and recurrent breast cancers, other cancers, deaths plus known side effects of anastrozole to continue to measure the long-term effects of anastrozole in these women.
Who can participate?
As this study follows an existing cohort there is no additional recruitment.
What does the study involve?
Long-term follow-up of the IBIS-II DCIS and Prevention cohorts via NHS Digital.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Queen Mary University of London
When is the study starting and how long is it expected to run for?
July 2018 to June 2026
Who is funding the study?
AstraZeneca (UK)
Who is the main contact?
Barts Clinical Trials Unit, bartsctu@qmul.ac.uk
Contact information
Public
Wolfson Institute for Cancer Prevention
Queen Mary University
London
EC1M 6BQ
United Kingdom
| Phone | +44 (0)2078823517 |
|---|---|
| bartsctu@qmul.ac.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | No PIS for this study as cohorts consented in previous studies and were written to at the end of the main CTIMP studies |
| Scientific title | Observational long-term follow up study of participants from the IBIS-II DCIS and Prevention clinical trials |
| Study acronym | IBIS-II-O |
| Study objectives | Long-term follow up of participants from the IBIS-II studies (Prevention and DCIS) to understand long term benefits and risks of anastrozole; Prevention cohort: To determine if anastrozole is effective in preventing long-term breast cancer in postmenopausal women at increased risk of the disease. Ductal Carcinoma in Situ (DCIS) cohort: To determine if anastrozole is at least as effective as tamoxifen in long-term local control and prevention of contralateral disease in women with locally excised ER or PgR positive DCIS. |
| Ethics approval(s) |
Approved 30/07/2019, London - Fulham Research Ethics Committee (Barlow House 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 (0)207 104 8084, (0)207 104 8286; fulham.rec@hra.nhs.uk), ref: 19/LO/0984 |
| Health condition(s) or problem(s) studied | Breast cancer prevention |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | Measured at the end of the study: 1. IBIS-II Prevention cohort: incidence of breast cancer measured via data from the digital registry or local pathology report with histologically confirmed breast cancer, both invasive and non-invasive (i.e. including DCIS) when registry data is not sufficient 2. IBIS-II DCIS cohort: incidence of breast cancer measured using data from digital registry or local pathology report with histologically confirmed breast cancer, both invasive and non-invasive (i.e. including DCIS) when registry data is not sufficient. |
| Secondary outcome measures | Measured at the end of the study: 1. IBIS-II Prevention Cohort: breast cancer mortality 2. IBIS-II DCIS Cohort: breast cancer mortality Both measured via COD and date confirmed via data registry |
| Overall study start date | 01/07/2018 |
| Completion date | 01/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 3000 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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 |
| Date of first enrolment | 01/06/2021 |
| Date of final enrolment | 01/06/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
E1 4NS
United Kingdom
Sponsor information
University/education
Joint Research Management Office (JRMO)
Research Services
Dept. W
69-89 Mile End Road
London
E1 4UJ
England
United Kingdom
| Phone | +44 (0)2078823517 |
|---|---|
| research.governance@qmul.ac.uk | |
| Website | http://www.jrmo.org.uk |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- AstraZeneca PLC, Pearl Therapeutics
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high impact journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.0 | 11/06/2021 | 15/10/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
09/04/2024: The following changes were made:
1. The interventions were updated with the ClinicalTrials.gov numbers of the IBIS-II DCIS and Prevention clinical trials.
2. The intervention type was changed from drug to other.
3. Study participating centre Wolfson Institute of Preventative Medicine and Institute of Population Health Sciences was replaced with Queen Mary University of London.
4. The public contact was updated.
5. The ethics approval date was changed from the date of the approval of an amendment on 21/04/2021 to the date of the initial approval on 30/07/2019.
6. The overall study start date was amended from 21/04/2021 to 01/07/2018.
14/10/2021: Trial's existence confirmed by Fulham Ethics Committee.
