Prospective randomised comparison of granulocyte colony-stimulating factor (G-CSF) (filgrastim) secondary prophylaxis versus conservative management of chemotherapy-induced neutropenia to maintain dose intensity in chemotherapy for breast cancer

ISRCTN	ISRCTN89698860
DOI	https://doi.org/10.1186/ISRCTN89698860
Protocol serial number	BR0101
Sponsor	Anglo Celtic Cooperative Oncology Group (UK)
Funder	Anglo Celtic Cooperative Oncology Group, Amgen (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
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
Intervention	Standard iv chemotherapy regimens as per local guidelines. Patients entered into TACT or TANGO protocols, or other protocols of licensed chemotherapies which do not exclude G-CSF usage will be eligible for this protocol. Patients in the SECRAB trial will also be eligible. G-CSF to be dosed subcutaneously at 5 micrograms/kg from day 3 post chemotherapy until day 9 (7 days). For the purposes of dosing, the last day of chemotherapy administration will be day 1. In the case of Day 1/Day 8 regimens, G-CSF shall be dosed starting on day 10 for 7 days.
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	400
Key inclusion criteria	1. 18 years or older 2. Histologically confirmed invasive breast cancer 3. No concomitant malignancy 4. No prior chemotherapy (apart from the current regimen) 5. Previous neutropenic event on iv chemotherapy and considered of suitable risk and fitness to continue chemotherapy 6. Written informed consent
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	03/10/2001
Date of final enrolment	31/12/2006

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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