An Open Label, Randomised, Multicentre Study of Pegfilgrastim in Primary Versus Secondary Prophylaxis of Neutropenia as an Adjunct to Chemotherapy in Elderly Subjects With High Risk Breast Cancer.
Inclusion Criteria:
- High-risk, stage II-III breast cancer suitable for treatment with up
to 6 cycles of FEC-100 - Chemotherapy - Histologically proven greater than or equal to 1
axillary nodes positive - Oestrogen receptor negative or positive - Chemotherapy naïve -
VES 13 (Vulnerable Elders Survey) score less than or equal to 3 - ECOG performance status
less than or equal to 2 - ANC greater than or equal to 1.5 x 10^9/L - Platelets greater
than or equal to 100 x 10^9/L - Adequate renal function (serum creatinine less than 1.5 x
upper limit of normal (ULN)) - Before any study specific procedure the subject must give
written informed consent for participation in the study Exclusion Criteria: - Total serum
bilirubin greater than ULN according to institutional standard - Clinically significant
cardiac disease that would preclude the use of epirubicin (e.g., LVEF (left ventricular
ejection fraction)) less than 45% at rest by MUGA or echocardiogram - Prior bone marrow or
stem cell transplantation - Any premalignant myeloid condition or any malignancy with
myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous
leukaemia) - History of prior malignancy other than breast cancer with the exception of
curatively treated basal cell carcinoma, in situ cervical carcinoma or surgically cured
malignancies - Prior radiation therapy - Active infection or administration of systemic
antibiotics or anti-infectives within 72 hours before start of chemotherapy - Known
hypersensitivity to E coli-derived products (e.g., Filgrastim, HUMULIN®, Insulin,
L-Asparaginase, HUMATROPE®, Growth Hormone, INTRON A®) - Previous exposure to
pegfilgrastim or previous entry into this study - Known HIV infection - Inability to
understand the nature of the study and provide written informed consent - Subject
currently enrolled in another investigational device or drug trial(s) or has received
other investigational agent(s), with the exception of placebo-treated subjects, within the
last 30 days - Concerns for subject's compliance with the protocol procedures