Cancer Research Campaign adjuvant breast trial for patients under 50

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
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
Study type	Participant information sheet
Scientific title	Cancer Research Campaign adjuvant trial
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	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.
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	22/03/1999

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Key inclusion criteria	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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1994
Date of final enrolment	22/03/1999

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	10-year follow-up results	01/06/1992		Yes	No
Protocol article	protocol	01/06/1989		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

08/10/2018: Publication reference added.