Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OVER50
Study information
Scientific title
Cancer Research Campaign adjuvant breast trial for patients over the age of 50
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
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Tamoxifen
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1995
Overall trial end date
03/12/2000
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1995
Recruitment end date
03/12/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
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