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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN89698860
Enrollment
400
Registered
2002-08-19
Start date
2001-10-03
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Breast

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 eligi

Sponsors

Anglo Celtic Cooperative Oncology Group (UK)
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026