| Source of record | UK Trials |
| ISRCTN | ISRCTN19151731 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | C142 |
| Public title | A blinded randomised multicentre study to evaluate fixed dose single administration filgrastim-SD/01 vs. daily Filgrastim as an adjuvant to chemotherapy Stage II or III/IV 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. 18 years of age or older
2. Can be chemotherapy naive and/or have no more than one previous regimen of chemotherapy for metastatic disease
3. Blood results within acceptable range |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/11/1999 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Two Arms:
Filgrastim 5 mg/kg/day 0.3 mg/ml Filgrastim - SD/01 0.6 ml (of a 10 mg/ml solution) |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Amgen |
| Sponsor name | Amgen Limited |
| Sponsor details | 240 Cambridge Science Park
Cambridge
United Kingdom
CB4 4WD |
| Sponsor telephone | +44(0)1223 420305 |
| Sponsor fax | +44(0)1223 423049 |
| Sponsor website | http://www.amgen.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 | ISRCTN19151731 |
| Date last extracted from ISRCTN register | 17/04/2008 |
