A Phase II Study of Dose Density Regimen With Fluorouracil, Epirubicin and Cyclophosphamide at Days 1, 4 Every 14 Days With Filgrastim Support Followed by Weekly Paclitaxel in Women With Primary Breast Cancer.

Exclusion Criteria

• •Metastatic disease
• •Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
• •Contraindications or hypersensitivity to study drugs;
• •Past (less than 10 years) or current history of malignant neoplasms, except for curatively treated 1) basal and squamous cell carcinoma of the skin or 2) carcinoma in situ of the cervix.
• •NOTE: Patients with a prior malignancy diagnosed greater than 10 years in the past who have been curatively treated with surgery ONLY, WITHOUT radiation therapy or systemic therapy (chemotherapy or endocrine) are eligible for the study. Patients with any prior diagnosis of invasive breast cancer or melanoma, at any time, are excluded from this study.
• •Serious cardiac illness or medical conditions including but not confined to:
• •* History of documented congestive heart failure (CHF) or systolic dysfunction (LVEF \<55%);
• •* High-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately rate-controlled);
• •* Angina pectoris requiring antianginal medication;
• •* Clinically significant valvular heart disease;
• •* Evidence of transmural infarction on ECG;
• •* Poorly controlled hypertension (e.g. systolic \>180mm Hg or diastolic \>100mm Hg);
• •Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness;
• •Any of the following abnormal laboratory tests immediately prior to randomisation:
• •* serum total bilirubin \>1.5 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (\<2 x ULN) is allowed
• •* alanine amino transferase (ALAT) or aspartate amino transferase (ASAT) \>2.5 x ULN;
• •* alkaline phosphatase (ALP) \>2.5 x ULN;
• •* serum creatinine \>2.0 x ULN;
• •* total white blood cell count (WBC) \<2.5 x 109/L;
• •* absolute neutrophil count \<1.5 x 109/L;
• •* platelets \<100 x 109/L.
• •Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication. Subjects with ulcerative colitis are also excluded;
• •Pregnant, lactating or women of childbearing potential without a negative pregnancy test - urine or serum, within 7 days prior to randomization, irrespective of the method of contraception used, including tubal ligation.
• •Women of childbearing potential, including women whose last menstrual period was \<12 months ago (unless surgically sterile) who are unable or unwilling to use adequate contraceptive measures during study treatment. (adequate contraceptive measures are intra-uterine device, barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable or implant hormonal contraceptives are not allowed on this study)