|
ISRCTN
|
ISRCTN72493595
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A trial to study the place of surgery in elderly women with breast cancer treated by tamoxifen
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
CRCBCTG6
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Breast
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
01/01/1995
|
|
Anticipated end date
|
31/12/1997
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Not available
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
-
-
|
|
Address
|
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 20 7670 4723
|
|
Fax
|
+44 (0) 20 7670 4818
|
|
Email
|
register@ctu.mrc.ac.uk
|
|
Sponsor
|
UK Co-ordinating Committee for Cancer Research (UKCCCR)
|
|
Address
|
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 20 7670 4723
|
|
Fax
|
+44 (0) 20 7670 4818
|
|
Email
|
|
|
Date applied
|
01/07/2001
|
|
Last edited
|
13/05/2008
|
|
Date ISRCTN assigned
|
01/07/2001
|