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ISRCTN
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ISRCTN89772270
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ClinicalTrials.gov identifier
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Public title
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A Multicentre Randomised Trial of Sequential Epirubicin and Docetaxel versus Epirubicin in Node Positive Postmenopausal Breast Cancer Patients
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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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DEVA
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Study hypothesis
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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
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Participants - inclusion criteria
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1. Post-menopausal, histologically confirmed node positive breast without distant metastases
2. World Health Organisation (WHO) 1 or 2
3. No evidence of significant cardiac disease
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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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01/08/1997
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Anticipated end date
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31/12/2005
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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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Not provided at time of registration
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Interventions
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Arm A. Epirubicin (50 mg/m2) IV days 1 and 8, every 28 days for 6 cycles (12 doses).
Arm B. Epirubicin (50 mg/m2) IV days 1 and 8 every 28 days for 3 cycles (6 doses) followed by docetaxel (100 mg/m2) IV over 1 h, day 1 every 21 days for 3 cycles.
All estrogen receptor (ER) and/or progesterone receptor (PgR) positive patients must receive tamoxifen 20 mg od for 5 years. In selected centres, timing of start of tamoxifen is randomised between:
Arm 1. Concurrent tamoxifen
Arm 2. Sequential tamoxifen.
Patients who are ER/PgR negative may take part in the tamoxifen arms at the clinicians' discretion.
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Primary outcome measure(s)
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Not provided at time of registration
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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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International Collaborative Cancer Group (UK)
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
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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Sponsor
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International Collaborative Cancer Group (ICGG) (UK)
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Address
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Medical Oncology
Charing Cross Hospital
Fulham Palace Road
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City/town
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London
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Zip/Postcode
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W6 8RF
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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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19/08/2002
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Last edited
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19/05/2008
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Date ISRCTN assigned
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19/08/2002
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