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ISRCTN
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ISRCTN11883920
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ClinicalTrials.gov identifier
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Public title
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A randomised double-blind trial in post-menopausal women with primary breast cancer who have received adjuvant tamoxifen for 2-3 years, comparing subsequent adjuvant exemestane treatment with further tamoxifen
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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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960EXE031
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Study hypothesis
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Early improvements in disease-free survival have been noted when an aromatase inhibitor is given either instead of or sequentially after tamoxifen in postmenopausal women with oestrogen-receptor-positive early breast cancer. However, little information exists on the long-term effects of aromatase inhibitors after treatment, and whether these early improvements lead to real gains in survival.
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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 double-blind controlled trial
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Countries of recruitment
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International
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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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1. Histologically/cytologically confirmed unilateral operable breast adenocarcinoma
2. Estrogen receptor (ER)+ or ER unknown
3. Adequate therapy for primary disease
4. Postmenopausal
5. Receiving tamoxifen and treated with tamoxifen for 2-3 years
6. Remain free from disease following treatment for primary 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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01/01/1998
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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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4724
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Interventions
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1. Patients in the reference arm will receive an overall course of tamoxifen for 5 years (20 mg/day)
2. Patients in the investigational arm will receive 25 mg/day exemestane (after 2-3 years tamoxifen giving a total of 5 years endocrine therapy)
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Primary outcome measure(s)
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Disease-free survival
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Secondary outcome measure(s)
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Overall survival
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Sources of funding
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Pharmacia and Upjohn (UK)
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Trial website
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Publications
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1. 2004 results of the 2nd interim analysis of efficacy in http://www.ncbi.nlm.nih.gov/pubmed/15014181
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17307102
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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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Pharmacia Ltd (UK)
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Address
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Davy Avenue
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City/town
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Milton Keynes
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Zip/Postcode
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MK5 8PH
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Country
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United Kingdom
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Tel
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+44 (0)1908 661101
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Fax
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+44 (0)1908 690091
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Email
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Sponsor website:
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http://www.pharmacia.com
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Date applied
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19/08/2002
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Last edited
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10/11/2008
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Date ISRCTN assigned
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19/08/2002
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