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ISRCTN
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ISRCTN75147488
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DOI
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10.1186/ISRCTN75147488
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ClinicalTrials.gov identifier
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NCT00002953
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EudraCT number
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Public title
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A randomised trial of epirubicin and cyclophosphamide versus epirubicin and paclitaxel in the treatment of women with metastatic breast cancer
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Scientific title
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Acronym
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N/A
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Serial number at source
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AB01
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Study hypothesis
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To compare epirubicin and paclitaxel versus epirubicin and cyclophosphamide in metastatic breast cancer
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Lay summary
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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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South Africa, United Kingdom
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Disease/condition/study domain
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Cancer
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Participants - inclusion criteria
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1. Metastatic breast cancer previously untreated except in adjuvant setting
2. Exposure to anthracyclines limited
3. Treatment free interval more than 6 months
4. Normal ejection fraction
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Participants - exclusion criteria
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History of cardiac disease
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Anticipated start date
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01/12/1996
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Anticipated end date
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05/11/1999
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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700
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Interventions
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Epirubicin and paclitaxel/epirubicin and cyclophosphamide
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Primary outcome measure(s)
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Progression free survival.
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Secondary outcome measure(s)
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Overall survival, response, toxicity, quality of life (Fact-B Quality of Life, Questionnaire); and health economics (Cost and Resource Use Questionnaire).
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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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Publications
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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16293863
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Contact name
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Dr
Barbara
Uscinska
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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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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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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28/02/2001
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Last edited
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07/10/2009
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Date ISRCTN assigned
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28/02/2001
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