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
| ISRCTN | ISRCTN19151731 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19151731 |
| Protocol serial number | C142 |
| Sponsor | Amgen Limited (UK) |
| Funder | Amgen (UK) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 17/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Blinded randomised multicentre study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific 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 |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Breast Cancer |
| Intervention | 1. Filgrastim 5 mg/kg/day 0.3 mg/ml 2. Filgrastim - SD/01 0.6 ml (of a 10 mg/ml solution) |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | filgrastim |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/1999 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/11/2015: No publications found in PubMed.
