Primary G-CSF prophylaxis during the first two cycles only or throughout all chemotherapy cycles in breast cancer patients at risk of febrile neutropenia

INTERVENTION: Trade Name: Neulasta Product Name: Neulasta Pharmaceutical Form: Injection* CONDITION: Prophylaxis of febrile neutropenia during chemotherapy ; MedDRA version: 9.1 Level: LLT Classification code 10016288 Term: Febrile neutropenia PRIMARY OUTCOME: 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.; 2.To compare costs per treatment arm.; Primary end point(s): % episodes of febrile neutropenia in treatment arms Secondary Objective: ‐Febrile neutropenia rates per cycle number.; ‐Other haematological and non‐haematological toxicities.; ‐Number of chemotherapy cycles delivered.; ‐Dose and dose‐intensity of chemotherapy.; ‐Disease progression.; ‐Number of toxic deaths per treatment arm.; INCLUSION CRITERIA: ‐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