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ISRCTN
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ISRCTN31514446
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DOI
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10.1186/ISRCTN31514446
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ClinicalTrials.gov identifier
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NCT00002582
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EudraCT number
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Public title
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The NCRI adjuvant breast cancer (ABC) trial
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Scientific title
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Acronym
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ABC
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Serial number at source
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G9437812
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Study hypothesis
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To determine the value of adding cytotoxic chemotherapy and/or (in premenopausal women) ovarian suppression to prolonged tamoxifen in women with early breast cancer.
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Lay summary
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Not provided at time of registration
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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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All women with early invasive breast cancer requiring adjuvant systemic therapy are eligible for the trial providing they have:
1. Early (operable) breast cancer
2. Histological confirmation of invasive carcinoma
3. No previous malignancy (except carcinoma in situ [CIS] cervix or basal cell carcinoma)
4. Received no previous systemic treatment for their disease
5. Given consent and available for subsequent follow-up
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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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01/01/1993
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Anticipated end date
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30/09/2005
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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6000
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Interventions
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Cytotoxic chemotherapy and/or (in premenopausal women) ovarian suppression and prolonged tamoxifen/tamoxifen
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Primary outcome measure(s)
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The main endpoint used for evaluation of treatment efficacy will be overall survival based on all cause mortality. Relapse-free survival, breast cancer mortality and cardiovascular mortality will also be compared. In a subset of patients there will be a detailed assessment of quality of life. Health economic consequences will also be determined. Ongoing biological predictors of therapeutic response studies, funded by CRUK and BCC.
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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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Medical Research Council (UK)
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Trial website
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http://www.icr.ac.uk/research/research_sections/clinical_trials/clinical_trials_list/2413_disease.shtml
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Publications
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Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17405996
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Contact name
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Ms
Judith
Bliss
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Address
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Section of Epidemiology
The Institute of Cancer Research
15 Cotswold Road
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City/town
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Sutton
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Zip/Postcode
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SM2 5NG
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Country
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United Kingdom
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Tel
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+44 (0)20 8722 4040
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Fax
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+44 (0)20 8 770 7876
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Email
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abc-icrctsu@icr.ac.uk
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Sponsor
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Institute of Cancer Research (UK)
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Address
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123 Old Brompton Road
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City/town
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London
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Zip/Postcode
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SW7 3RP
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Country
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United Kingdom
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Tel
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+44 (0)20 7352 8133
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Fax
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+44 (0)20 7370 5261
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Email
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abc-icrctsu@icr.ac.uk
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Sponsor website:
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http://www.icr.ac.uk/
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Date applied
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06/04/2000
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Last edited
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02/02/2012
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Date ISRCTN assigned
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06/04/2000
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