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

ISRCTN	ISRCTN29547753
DOI	https://doi.org/10.1186/ISRCTN29547753
Secondary identifying numbers	OVER50

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

- - -
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Tamoxifen
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1995
Completion date	03/12/2000

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Not provided at time of registration
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

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan