| Source of record | UK Trials |
| ISRCTN | ISRCTN89698860 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | BR0101 |
| Public title | 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 |
| Scientific title |
|
| Acronym | N/A |
| 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 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 03/10/2001 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Anglo Celtic Cooperative Oncology Group, Amgen |
| Sponsor name | Anglo Celtic Cooperative Oncology Group |
| Sponsor details | SCTN Central Office
Information & Statistics Division
Trinity Park House
South Trinity Road
Edinburgh
United Kingdom
EH5 3SQ |
| Sponsor telephone | +44 (0)131 551 8363 |
| Sponsor fax | +44 (0)131 552 4085 |
| Sponsor email | joanna.dunlop@isd.csa.scot.nhs.uk |
| 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 | ISRCTN89698860 |
| Date last extracted from ISRCTN register | 17/04/2008 |
