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

Observational long-term follow up study of participants from the IBIS-II DCIS and Prevention clinical trials

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN17443780

Enrollment

3000

Registered

2021-11-15

Start date

2021-06-01

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer prevention Cancer

Interventions

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 datas

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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 Participant has withdrawn consent to participate in IBIS-II Prevention and DCIS CTIMP studies 3. Participant has withdrawn consent to digital registry flagging in the IBIS-II Prevention and DCIS CTIMP study 4.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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

England, United Kingdom

Contacts

Public ContactBarts Clinical Trials Unit

bartsctu@qmul.ac.uk+44 (0)2078823517

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 25, 2026