| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN35478997 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | BR9601 |
| Public title | A Prospective Randomised Comparison of CMF versus Sequential Epirubicin Followed by CMF as Adjuvant Chemotherapy for Women with Early Breast Cancer |
| Scientific title |
|
| Acronym | Not Applicable |
| 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. Histologically confirmed breast cancer
2. Histologically confirmed axillary node metastases
3. Fit to receive chemotherapy on either arm of the trial
4. Adequate hepatic, renal and bone marrow function
5. No previous chemotherapy
6. No prior or concomitant malignancy, except basal cell carcinoma or in situ carcinoma of the cervix
7. No bilateral breast tumours or locally advanced or metastatic breast cancer, including supraclavicular fossa metastases |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 30/04/2001 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. Group A: Chemotherapy, cyclophosphamide, methotrexate and 5-fluorouracil (CMF) repeated every 3 weeks for eight cycles
2. Group B: Chemotherapy, epirubicin repeated every 3 weeks for four cycles followed by CMF repeated every 3 weeks for four cycles |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| 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 |
| 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 | ISRCTN35478997 |
| Date last extracted from ISRCTN register | 17/04/2008 |
