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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN19151731
Enrollment
Unknown
Registered
2002-08-19
Start date
1999-11-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Breast Cancer Cancer Breast Cancer

Interventions

1. Filgrastim 5 mg/kg/day 0.3 mg/ml 2. Filgrastim - SD/01 0.6 ml (of a 10 mg/ml solution)

Sponsors

Amgen Limited (UK)
Lead Sponsor

Eligibility

Inclusion criteria

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

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