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 |
| 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 |
Editorial Notes
17/11/2015: No publications found in PubMed.
