| Source of record | UK Trials |
| ISRCTN | ISRCTN14666896 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | ICCG/4/87 |
| Public title | Epirubicin plus Tamoxifen versus Tamoxifen alone in Post-Menopausal Node Positive Primary Breast Cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Breast cancer |
| 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 | The Netherlands, United Kingdom, France, Belgium, Spain, Greece |
| Participants - inclusion criteria | 1. Post-menopausal as determined by:
a. Last menstrual cycle 12 months before surgery
b. Patients any age with previous bilateral oophorectomy
c. Patients aged >50 years who have had hysterectomy without oopherectomy as long as the reason for surgery was not a malignancy
2. Aged <75 years
3. Histologically proven non metastatic T1-T3 with at least one involved ipsilateral axillary node
4. Adequate renal and haematological function
5. No prior history of malignant breast tumours
6. No bilateral malignancy or inflammatory breast cancer
7. No previous or concomitant malignancy, except squamous or basal cell carcinoma of the skin which has been effectively treated or carcinoma of the cervix in situ which has been treated operatively only
8. No non malignant systemic disease
9. No definite indication for chemotherapy |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/1996 |
| Anticipated end date | 28/02/1998 |
| Status of trial | Completed |
| Target number of participants | 604 |
| Interventions | 1. Regimen A: Tamoxifen 20 mg daily for 4 years
2. Regimen B: Tamoxifen 20 mg daily for 4 years plus chemotherapy, single agent epirubicin repeated every 4 weeks for six cycles |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Publications | 1999 results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=10561249 |
| Sources of funding | Pharmacia and Upjohn |
| Sponsor name | Pharmacia Ltd (UK) |
| Sponsor details | Davy Avenue
Milton Keynes
United Kingdom
MK5 8PH |
| Sponsor telephone | +44 (0)1908 661101 |
| Sponsor fax | +44 (0)1908 690091 |
| Sponsor email | sponsor@unknown.com |
| Sponsor website | http://www.pharmacia.com |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN14666896 |
| Date last extracted from ISRCTN register | 17/04/2008 |
