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ISRCTN
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ISRCTN52689949
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ClinicalTrials.gov identifier
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Public title
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Cancer Research Campaign adjuvant breast trial for patients under 50
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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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CRCBCTG9
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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 cancer
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Participants - inclusion criteria
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1. Aged < 50 years
2. Operable breast cancer, that is clinically T1,T2 or T3,N0 or N1,M0
3. No evidence of metastases
4. Normal renal, hepatic function and full blood counts, including platelets
5. Patients with bilateral tumours are not eligible
6. No concomitant hormonal therapy or chemotherapy
7. No hormonal therapy in the last 6 weeks
8. No previous malignancy, except basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix adequately cone biopsied
9. Fit to receive either 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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01/01/1994
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Anticipated end date
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22/03/1999
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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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Not provided at time of registration
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Interventions
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Following surgery (local excision or mastectomy) with or without additional primary therapy patients are randomised to either:
1. Group A: No further treatment.
2. Group B: Adjuvant tamoxifen, 20 mg daily for 2 years. Treatment to start as soon as possible following surgery.
3. Group C: Zoladex, 3.6 mg depot/month for 2 years. Treatment to start as soon as possible following surgery.
4. Group D: Tamoxifen 20 mg daily and Zoladex 3.6 mg depot/month both for 2 years. Treatment to start as soon as possible following surgery.
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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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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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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.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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23/05/2008
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Date ISRCTN assigned
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01/07/2001
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