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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00072462




Registration number
NCT00072462
Ethics application status
Date submitted
4/11/2003
Date registered
6/11/2003
Date last updated
6/10/2021

Titles & IDs
Public title
Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ
Scientific title
International Breast Cancer Intervention Study II (IBIS-II) (DCIS)
Secondary ID [1] 0 0
EU-20226
Secondary ID [2] 0 0
ISRCTN37546358
Universal Trial Number (UTN)
Trial acronym
IBIS-II DCIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - tamoxifen citrate
Treatment: Drugs - Anastrozole

Active Comparator: Anastrozole -

Active Comparator: Tamoxifen -


Treatment: Drugs: tamoxifen citrate
Tamoxifen 20mg + Anastrozole placebo

Treatment: Drugs: Anastrozole
Anastrozole 1mg + Tamoxifen placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
To examine the effect of tamoxifen vs anastrozole on breast cancer mortality
Timepoint [1] 0 0
7 years

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Diagnosis of ductal carcinoma in situ within the past 6 months

- Locally excised with tumor-free margins at least 1 mm

- Hormone receptor status:

- Estrogen or progesterone receptor positive

- Equal to or greater than 5% positive cells

PATIENT CHARACTERISTICS:

Age

- 40 to 70

Sex

- Female

Menopausal status

- Postmenopausal, defined as meeting at least 1 of the following criteria:

- Over age 60

- Prior bilateral oophorectomy

- Age 60 or under with a uterus AND amenorrhea for at least the past 12 months

- Age 60 or under without a uterus AND follicle-stimulating hormone greater than 20
IU/L

Performance status

- Not specified

Life expectancy

- At least 10 years

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Cardiovascular

- No prior deep vein thrombosis

- No prior transient ischemic attack

- No prior cerebrovascular accident

Pulmonary

- No prior pulmonary embolism

Other

- No unexplained postmenopausal bleeding

- No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in
situ of the cervix

- No other concurrent medical condition that would preclude study therapy, place the
patient at unusual risk, or confound study results

- No evidence of osteoporosis

- Fragility fractures within the spine allowed if T-score level is greater than -4 and
consist of no more than 2 fractures

- Psychologically and physically suitable for 5 years of study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- No prior or concurrent tamoxifen use lasting more than 6 months unless treatment was
completed more than 5 years ago. Women in IBIS-I can join if off trial therapy for at
least 5 years.

- No prior or concurrent raloxifene use lasting more than 6 months unless treatment was
completed more than 5 years ago.

- No other prior or concurrent selective estrogen-receptor modulator use lasting more
than 6 months unless treatment was completed more than 5 years ago

- No concurrent systemic estrogen-based hormone replacement therapy, including vaginal
estrogen preparations

Radiotherapy

- Not specified

Surgery

- See Disease Characteristics

- No prior mastectomy

- No planned prophylactic mastectomy

Other

- At least 3 months since prior unapproved or experimental agents

- No concurrent anticoagulants
Minimum age
40 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/05/2021
Sample size
Target
Accrual to date
Final
2980
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Australia - Newcastle
Recruitment postcode(s) [1] 0 0
- Newcastle
Recruitment outside Australia
Country [1] 0 0
Austria
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Vienna
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Belgium
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Leuven
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Chile
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Santiago
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France
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Avignon
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France
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Bordeaux
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France
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Brest
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France
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Caen
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Clermont-Ferrand
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France
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Dijon
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France
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Lagny Sur Marne
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Le Havre
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Lille
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Mulhouse
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France
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Nantes
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Perpignan
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Reims
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France
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Rennes
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Rouen
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France
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Toulouse
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France
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Villejuif
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Germany
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Neu-Isenburg
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Hungary
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Szeged
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Ireland
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Cork
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Ireland
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Dublin
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Ireland
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Galway
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Ireland
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Limerick
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Sligo
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Tallaght
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Italy
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Milan
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Malta
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Floriana
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Sweden
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Lund
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Switzerland
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(St. Gallen)
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Switzerland
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Bern
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Switzerland
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Geneva
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Lausanne
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Switzerland
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Luzern
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Switzerland
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Mendrisio
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Switzerland
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St. Gallen
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Switzerland
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Thun
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Turkey
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Istanbul
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United Kingdom
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England
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United Kingdom
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Northern Ireland
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United Kingdom
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Please Select
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Scotland
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Wales
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Aberdeen
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Ashton under Lyne
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Bolton
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Bournemouth
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Bradford
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Brighton
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Bristol
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Burton
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Cheltenham
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Chester
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Derby
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Epping
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Exeter
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Frimley
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Grantham
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Hastings
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Huddersfield
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Hull
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Keighley
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Leeds
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United Kingdom
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Lincoln
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Plymouth
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Portsmouth
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Scarborough
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Sheffield
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Stafford
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Swansea
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Truro
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Wakefield
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Welwyn
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Wishaw
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Worthing
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United Kingdom
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Yeovil
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United Kingdom
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York

Funding & Sponsors
Primary sponsor type
Other
Name
Queen Mary University of London
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cancer Research UK
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using
either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It
is not yet known whether tamoxifen is more effective than anastrozole in preventing breast
cancer after surgery for ductal carcinoma in situ.

PURPOSE: This randomized phase III trial is studying how well adjuvant tamoxifen works
compared to anastrozole in treating postmenopausal women who have undergone surgery to remove
ductal carcinoma in situ.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00072462
Trial related presentations / publications
Juraskova I, Butow P, Lopez A, Seccombe M, Coates A, Boyle F, McCarthy N, Reaby L, Forbes JF. Improving informed consent: pilot of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II DCIS). Health Expect. 2008 Sep;11(3):252-62. doi: 10.1111/j.1369-7625.2008.00498.x.
Forbes JF, Sestak I, Howell A, Bonanni B, Bundred N, Levy C, von Minckwitz G, Eiermann W, Neven P, Stierer M, Holcombe C, Coleman RE, Jones L, Ellis I, Cuzick J; IBIS-II investigators. Anastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): a double-blind, randomised controlled trial. Lancet. 2016 Feb 27;387(10021):866-73. doi: 10.1016/S0140-6736(15)01129-0. Epub 2015 Dec 11.
Sestak I, Smith SG, Howell A, Forbes JF, Cuzick J. Early participant-reported symptoms as predictors of adherence to anastrozole in the International Breast Cancer Intervention Studies II. Ann Oncol. 2018 Feb 1;29(2):504-509. doi: 10.1093/annonc/mdx713.
Public notes

Contacts
Principal investigator
Name 0 0
Jack Cuzick, PhD
Address 0 0
Queen Mary University of London
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00072462