Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CRCBCTG6
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study 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
Intervention
1. Group A: Optimal surgery plus tamoxifen, 20 mg twice daily
2. Group B: Tamoxifen, 20 mg twice daily
All patients receive tamoxifen until there is evidence of progressive disease.
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
01/01/1995
Overall study end date
31/12/1997
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged >70 years
2. Histological, cytological or unequivocal mammographic confirmation of carcinoma of the breast
3. Operable breast cancer
4. No metastases
5. No previous malignancy, except skin cancer or adequately treated in situ carcinoma of the cervix
6. Fit and willing to receive either treatment
Participant type(s)
Patient
Age group
Senior
Sex
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Patients with bilateral breast cancer are excluded
2. Patients with Paget's disease without a palpable lump, in situ carcinoma or an impalpable lesion shown on mammograph alone are excluded
Recruitment start date
01/01/1995
Recruitment end date
31/12/1997
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
UK Co-ordinating Committee for Cancer Research (UKCCCR)
Sponsor details
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Sponsor type
Government
Website
ROR
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/1997 | Yes | No |