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ISRCTN
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ISRCTN95231655
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ClinicalTrials.gov identifier
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NCT00002580
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Public title
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Scottish Pre-Menopausal Chemo-Endocrine Trial
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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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BR9401
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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. Histologically confirmed invasive carcinoma of the breast
2. Pre-menopausal
3. No medical contraindications to treatment
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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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01/06/1993
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Anticipated end date
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31/12/2003
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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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Following surgery patients are randomised to one of four treatment arms:
1. Group A: Tamoxifen 20 mg daily for 5 years
2. Group B: Tamoxifen 20 mg daily for 5 years plus six cycles of CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy
3. Group C: Tamoxifen 20 mg daily for 5 years plus ovarian suppression
4. Group D: Tamoxifen 20 mg daily for 5 years, six cycles of CMF chemotherapy and ovarian suppression
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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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Scottish Cancer Therapy Network (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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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Scottish Cancer Therapy Network (UK)
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Address
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Trinity Park House
South Trinity Road
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City/town
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Edinburgh
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Zip/Postcode
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EH5 3SQ
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Country
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United Kingdom
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Date applied
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19/08/2002
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Last edited
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14/05/2008
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Date ISRCTN assigned
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19/08/2002
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