Cancer Research Campaign adjuvant breast trial for patients under 50

ISRCTN	ISRCTN52689949
DOI	https://doi.org/10.1186/ISRCTN52689949
ClinicalTrials.gov number	NCT00002460
Secondary identifying numbers	CRCBCTG9

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1994
Completion date	22/03/1999

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

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

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

08/10/2018: Publication reference added.