A trial to study the place of surgery in elderly women with breast cancer treated by tamoxifen
| ISRCTN | ISRCTN72493595 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72493595 |
| Secondary identifying numbers | CRCBCTG6 |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 13/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| 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 | |
| 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 |
| 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 |
| Completion date | 31/12/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/1995 |
| Date of final enrolment | 31/12/1997 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government
Government
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
"ROR" |
https://ror.org/054225q67 |
|---|
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/1997 | Yes | No |
