| Source of record | UK Trials |
| ISRCTN | ISRCTN43697410 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | BR9403 |
| Public title | Scottish Chemo-Endocrine Trial D |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Breast |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethics information not required at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Pre- or post-menopausal
2. Histologically confirmed palpable unilateral invasive breast cancer of TNM (Tumour, Node, Metastasis) stages T1-T3, N0-N1 and M0, for whom adjuvant chemotherapy is considered an essential part of initial therapy
3. A bilateral mammography to have been performed within the year prior to randomisation
4. Patients with in situ carcinoma only, including Paget's disease of the nipple without underlying invasion are excluded
5. No distant metastases
6. Patients must not currently be receiving tamoxifen
7. No prior history of other malignancy, other than adequately treated basal or squamous cell carcinoma of skin
8. No contraindications to treatment |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/1999 |
| Anticipated end date | 15/05/1999 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | All patients receive chemotherapy, CMF (Cyclophosphamide, Methotrexate and 5-Fluorouracil) repeated every three weeks for six cycles.
Patients are then randomised to one of two treatment groups:
1. Group A: Tamoxifen, 20 mg daily for five years
2. Group B: No further treatment |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Scottish Therapy Network (UK) |
| Sponsor name | Scottish Cancer Therapy Network |
| Sponsor details | Trinity Park House
South Trinity Road
Edinburgh
United Kingdom
EH5 3SQ |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN43697410 |
| Date last extracted from ISRCTN register | 17/04/2008 |
