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Clinical Trial Results:
International Breast Cancer Intervention Study II (DCIS). An international multi-centre trial of tamoxifen v anastrozole in post-menopausal women with ductal carcinoma in situ.

Summary
EudraCT number	2004-003992-35
Trial protocol	SE
Global end of trial date	31 May 2021

Results information
Results version number	v1(current)
This version publication date	12 May 2022
First version publication date	12 May 2022
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
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Trial information

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Sponsor protocol code

MREC02/8/71

ISRCTN number

ISRCTN37546358

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Queen Mary University London

Sponsor organisation address

Wolfson Institute of Population Health, London, United Kingdom, EC1M 6BQ

Public contact

Professor Jack Cuzick, Queen Mary University London, j.cuzick@qmul.ac.uk

Scientific contact

Professor Jack Cuzick, Queen Mary University London, j.cuzick@qmul.ac.uk

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

31 May 2021

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

31 May 2021

Was the trial ended prematurely?

Yes

Main objective of the trial

To determine if anastrozole is at least as effective as tamoxifen in local control and prevention of contralateral disease in women with locally excised ER or PgR+ve DCIS and to compare side effect profiles of tamoxifen and anastrozole.

Protection of trial subjects

Eligibility criteria were risk-based, varied by age, and defined in the protocol to ensure protection of participants. Participants were informed of potential side-effects prior to study entry and if new side-effects were added to the Summary of Product Characteristics (SmPC) after randomisation, women were informed at their next clinic appointment. Women were informed of their right to withdraw at any point. Only post-menopausal women diagnosed with locally excised, hormone-receptor-positive DCIS were eligible. Women aged 60 without a uterus were eligible if they had FSH levels >30 IU/L and if taking HRT, an 8 week wash-out period was required prior to a FSH test being performed. Due to potential concerns over the effects of the trial interventions on pre-existing conditions associated with low bone mineral density, women with osteoporosis were excluded and a DXA scan and spinal radiograph within the last two years was required prior to randomisation. Advice on maintaining healthy bones was offered to women in the trial. Treatment with bisphosphonates was considered where necessary. If serious menopausal symptoms developed during treatment, management followed a protocolised approach including details on when to reduce dosing of the trial intervention. Circumstances which indicated cessation of the IMP were listed in the protocol. A codebreak procedure to unblind clinicians and participants was active throughout the study. Adverse events were collected and reviewed regularly by the Trial team and Steering Committee.

Background therapy

Evidence for comparator

IBIS-II (DCIS) is designed to continue the work started in IBIS-I in determining whether a chemo preventive strategy towards breast cancer is beneficial. IBIS-I was set up to investigate the use of tamoxifen as a preventive agent for women with moderate to increased risk of getting breast cancer. IBIS-II (DCIS) is a randomized double blind control trial which will compare tamoxifen versus anastrozole in women with locally excised ER or PgR positive Ductal Carcinoma In-Situ (ER or PgR+ve DCIS).

Actual start date of recruitment

03 Mar 2003

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy, Scientific research

Long term follow-up duration

5 Years

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country