| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN89772270 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | DEVA |
| Public title | A Multicentre Randomised Trial of Sequential Epirubicin and Docetaxel versus Epirubicin in Node Positive Postmenopausal Breast Cancer Patients |
| 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 | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Post-menopausal, histologically confirmed node positive breast without distant metastases
2. World Health Organisation (WHO) 1 or 2
3. No evidence of significant cardiac disease |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/08/1997 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Arm A. Epirubicin (50 mg/m2) IV days 1 and 8, every 28 days for 6 cycles (12 doses).
Arm B. Epirubicin (50 mg/m2) IV days 1 and 8 every 28 days for 3 cycles (6 doses) followed by docetaxel (100 mg/m2) IV over 1 h, day 1 every 21 days for 3 cycles.
All estrogen receptor (ER) and/or progesterone receptor (PgR) positive patients must receive tamoxifen 20 mg od for 5 years. In selected centres, timing of start of tamoxifen is randomised between:
Arm 1. Concurrent tamoxifen
Arm 2. Sequential tamoxifen.
Patients who are ER/PgR negative may take part in the tamoxifen arms at the clinicians' discretion. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | International Collaborative Cancer Group |
| Sponsor name | International Collaborative Cancer Group (ICGG), London, UK |
| Sponsor details | Medical Oncology
Charing Cross Hospital
Fulham Palace Road
London
United Kingdom
SW6 |
| 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 | ISRCTN89772270 |
| Date last extracted from ISRCTN register | 17/04/2008 |
