Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
08/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BR0101

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase III

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

03/10/2001

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

400

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

03/10/2001

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Anglo Celtic Cooperative Oncology Group (UK)

Sponsor details

SCTN Central Office
Information & Statistics Division
Trinity Park House
South Trinity Road
Edinburgh
EH5 3SQ
United Kingdom
+44 (0)131 551 8363
joanna.dunlop@isd.csa.scot.nhs.uk

Sponsor type

Research organisation

Website

http://www.amgen.com

Funders

Funder type

Industry

Funder name

Anglo Celtic Cooperative Oncology Group, Amgen (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes