Cancer Research Campaign adjuvant breast trial for patients over the age of 50

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

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Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Cancer Research Campaign adjuvant breast trial for patients over the age of 50
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Breast cancer
Intervention	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
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Tamoxifen
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	03/12/2000

Participant type(s)	Patient
Age group	Adult
Sex	Female
Key inclusion criteria	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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1995
Date of final enrolment	03/12/2000

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan