Scottish Pre-Menopausal Chemo-Endocrine Trial
| ISRCTN | ISRCTN95231655 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95231655 |
| ClinicalTrials.gov number | NCT00002580 |
| Secondary identifying numbers | BR9401 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 11/04/2019
- 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 | Following surgery patients are randomised to one of four treatment arms: 1. Group A: Tamoxifen 20 mg daily for 5 years 2. Group B: Tamoxifen 20 mg daily for 5 years plus six cycles of CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy 3. Group C: Tamoxifen 20 mg daily for 5 years plus ovarian suppression 4. Group D: Tamoxifen 20 mg daily for 5 years, six cycles of CMF chemotherapy and ovarian suppression |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Tamoxifen |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/1993 |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1000 |
| Key inclusion criteria | 1. Histologically confirmed invasive carcinoma of the breast 2. Pre-menopausal 3. No medical contraindications to treatment |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/1993 |
| Date of final enrolment | 31/12/2003 |
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
Scottish Cancer Therapy Network (UK)
Research organisation
Research organisation
Trinity Park House
South Trinity Road
Edinburgh
EH5 3SQ
United Kingdom
Funders
Funder type
Research organisation
Scottish Cancer Therapy Network (UK)
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 | 01/01/1999 | 14/02/2019 | Yes | No |
Editorial Notes
11/04/2019: Internal review.
14/02/2019: Publication reference added.
