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ISRCTN
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ISRCTN29941643
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ClinicalTrials.gov identifier
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NCT00079248
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Public title
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National randomised trial of hormone replacement therapy (HRT) in women with a history of early stage breast cancer
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Scientific title
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Acronym
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HRT
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Serial number at source
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N/A
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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. Patients must have had proven stage I/II breast cancer with no clinical evidence of recurrence since diagnosis
2. Have been given a patient information pack
3. Be postmenopausal as defined by:
a. Having been amenorrhoeic for at least 6 months (including women who have had radiation or chemical induced ovarian suppression) irrespective of menopausal status at time of diagnosis
b. Having received surgical bilateral oophorectomy
c. Be experiencing vasomotor symptoms (i.e. hot flushes or night sweats) with or without vaginal dryness.
All such women are eligible irrespective of current/previous treatment for breast cancer.
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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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01/08/2003
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Anticipated end date
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01/08/2006
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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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60
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Interventions
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Patients will be randomised to receive:
1. HRT
2. No HRT (advice about non-hormonal alternatives)
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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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Cancer Research UK
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Trial website
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Publications
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Contact name
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Ms
Jenni
Parmar
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Address
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Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Section of Epidemiology
Brookes Lawley Building
Cotswold Road
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City/town
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Sutton, Surrey
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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 4373
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Fax
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+44 (0)20 8770 7876
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Email
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HRT-icrctsu@icr.ac.uk
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Sponsor
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Individual Sponsor
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Address
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Mr Nigel Sacks
The Royal Marsden NHS Trust
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City/town
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London
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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 4373
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Fax
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+44 (0) 20 8770 7876
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Email
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Claire.Dawson@icr.ac.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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20/02/2006
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Date ISRCTN assigned
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01/07/2001
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