Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00002460
Protocol/serial number
CRCBCTG9
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1994
Overall trial end date
22/03/1999
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1994
Recruitment end date
22/03/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 1989 protocol in http://www.ncbi.nlm.nih.gov/pubmed/2613207
Publication citations
-
Protocol
Baum M, Houghton J, Riley DL, Melhuish PB, Cancer Research Campaign Adjuvant Breast Trial for patients under 50., Horm. Res., 1989, 32 Suppl 1, 226-9; discussion 230.