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ISRCTN
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ISRCTN17222211
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DOI
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10.1186/ISRCTN17222211
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ClinicalTrials.gov identifier
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NCT00003678
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EudraCT number
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Public title
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Adjuvant Tamoxifen Treatment - offer more? To assess reliably the balance of benefits and risks of prolonging adjuvant tamoxifen treatment by 5 years for women with breast cancer
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Scientific title
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Acronym
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aTTom
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Serial number at source
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BR3009
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Study hypothesis
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To assess reliably, the balance of benefits and risks of prolonging adjuvant tamoxifen treatment by 5 years, in women with early breast cancer
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Lay summary
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http://cancerhelp.cancerresearchuk.org/trials/tamoxifen-for-early-stage-breast-cancer
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Breast cancer
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Participants - inclusion criteria
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1. Any woman who has had complete excision of breast carcinoma
2. Any primary treatment
3. At least 2 years of prior adjuvant tamoxifen treatment (5 recommended)
4. Clinically relapse free
5. No definite indications or contraindications for further tamoxifen treatment: uncertainty as to whether further tamoxifen treatment will be of benefit
6. Where possible, ER status should be known prior to randomisation
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/1994
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Anticipated end date
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01/08/2014
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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8000
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Interventions
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Group A - No further treatment with tamoxifen
Group B - At least 5 years further treatment with tamoxifen
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Primary outcome measure(s)
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To detect or refute reliably any overall survival benefit from extending the duration of therapy with adjuvant tamoxifen
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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1. Cancer Research UK (UK)
2. Medical Research UK (UK)
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Trial website
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Publications
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Contact name
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Mr
Martin J
Lee
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Address
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Birmingham Clinical Trials Unit
University of Birmingham
Park Grange, 1 Somerset Road
Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2RR
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Country
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United Kingdom
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Email
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Sponsor
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The University of Birmingham (UK)
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Address
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Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Email
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Date applied
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22/03/2001
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Last edited
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01/12/2011
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Date ISRCTN assigned
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22/03/2001
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