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ISRCTN
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ISRCTN29547753
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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 over the age of 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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OVER50
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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. Aged >50 years and <70 years (revised to <80 years in February 1991)
2. Operable breast cancer (clinically T1, T2 or T3, N0 or N1, M0)
3. No evidence of metastases
4. Normal renal and 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 previous malignancy, except basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix adequately cone biopsied
8. Patients whose axillary nodes demonstrate deep fixity are not eligible
9. Patients whose primary cancer is fixed to the underlying muscle or chest wall, or those with ulceration, skin infiltration, peau d'orange or satellite skin nodules are not eligible
10. 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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01/01/1995
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Anticipated end date
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03/12/2000
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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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Patients receive primary surgical and irradiation treatments as are felt appropriate and are started on tamoxifen 20 mg daily.
Patients event-free and consenting at 2 years are randomised into one of two treatment groups:
1. Group A: Stop tamoxifen
2. Group B: Continue tamoxifen therapy for a further 3 years
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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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31/01/2008
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Date ISRCTN assigned
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01/07/2001
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