Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
C142
Study information
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
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Blinded randomised multicentre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
filgrastim
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/11/1999
Overall study end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/1999
Recruitment end date
31/12/2005
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Amgen Limited (UK)
Sponsor details
240 Cambridge Science Park
Cambridge
CB4 4WD
United Kingdom
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Amgen (UK)
Alternative name(s)
Amgen Inc., Applied Molecular Genetics Inc.
Funding Body Type
government organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|