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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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Scientific title
International Breast Cancer Intervention Study II (IBIS-II) (DCIS)
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Secondary ID [1]
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EU-20226
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Secondary ID [2]
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ISRCTN37546358
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Universal Trial Number (UTN)
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Trial acronym
IBIS-II DCIS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Cancer
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0
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Cervical (cervix)
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years
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Assessment method [1]
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Timepoint [1]
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2 years
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Secondary outcome [1]
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To examine the effect of tamoxifen vs anastrozole on breast cancer mortality
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Assessment method [1]
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Timepoint [1]
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7 years
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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
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Minimum age
40
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Maximum age
70
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/05/2021
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Sample size
Target
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Accrual to date
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Final
2980
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Recruitment in Australia
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Australia - Newcastle
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- Newcastle
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Austria
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Vienna
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Funding & Sponsors
Primary sponsor type
Other
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Name
Queen Mary University of London
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Cancer Research UK
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00072462
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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.
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Public notes
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Contacts
Principal investigator
Name
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Jack Cuzick, PhD
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Address
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Queen Mary University of London
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00072462
Download to PDF