Primary G-CSF prophylaxis during the first two cycles only or throughout all chemotherapy cycles in breast cancer patients at risk of febrile neutropenia - 2-2-6 STUDY
- Conditions
- Prophylaxis of febrile neutropenia during chemotherapyMedDRA version: 9.1Level: LLTClassification code 10016288Term: Febrile neutropenia
- Registration Number
- EUCTR2007-005402-53-NL
- Lead Sponsor
- Academisch Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
-Breast cancer patients =18 years
-Indication for 3-weekly chemotherapy.
-Chemotherapy in adjuvant, neo-adjuvant, advanced setting with an increased risk of febrile neutropenia, i.e.:
?regimes with >20% risk of febrile neutropenia: e.g. TAC (docetaxel, adriamycin, cyclophosphamide) or AT (adriamycine, docetaxel), or
?regimes with 10-20% risk of febrile neutropenia (e.g. AC, doxorubicin and vinorelbine, or docetaxel monotherapy) in the presence of =1 patient risk factor (>65 yrs, extensive bone marrow involvement or prior extensive radiotherapy on bone tissue, prior chemotherapy, ECOG performance status of 2 or less, grade 2 or higher liver function abnormalities).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
-Active uncontrolled infection.
-Inadequate renal or hepatic function.
-Any evidence or history of hypersensitivity or other contraindications to G-CSF medication.
-Not recovered from acute toxicities of prior therapies.
-Absolute neutrophil count (ANC) <1.5 x 109/l, not caused by bone marrow involvement.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1.To determine whether primary G-CSF prophylaxis throughout all chemotherapy cycles or primary G-CSF prophylaxis during the first two chemotherapy cycles only will be equivalent regarding incidence of febrile neutropenia.<br>2.To compare costs per treatment arm.<br>;Secondary Objective: -Febrile neutropenia rates per cycle number.<br>-Other haematological and non-haematological toxicities.<br>-Number of chemotherapy cycles delivered.<br>-Dose and dose-intensity of chemotherapy.<br>-Disease progression.<br>-Number of toxic deaths per treatment arm.<br>;Primary end point(s): % episodes of febrile neutropenia in treatment arms
- Secondary Outcome Measures
Name Time Method