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入排标准

•Metastati breast cancer (radiologic and hystologic evidence)
•Liver metastasis radiologically confirmed
•Cumulative dose of doxorubicin previously administered less or equal to 220 mg/m2 (360 mg/m2 for epirubicin)
•Evaluable disease following the WHO criteria
•Normal left ventricular function studied with a scintigraphy or an ecography
•Normal ECG and absence of clinical signs/syntomps of heart failure (NYHA < 2)
•Non evidence of present or pregress severe cardiovascular disease
•Normal blood cell count
•Normal epatic and renal function
•Non evidence of secondary cancers
•Basal ECOG 0 or 1
•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

•Pregnancy or lactation
•Severe infectious or other disease (clinically relevant)
•Cerebral metastasis
•Previous or concurrent malignancy
•Hypersensitivity to antracyclines, cyclophosphamide or iodinate contrasts
•Previous treatment with weekly antracyclines, taxanes or other metronomic chemotherapy

A PHASE II STUDY OF THE EFFECTIVENESS AND TOLERABILITY OF PEGYLATED LIPOSOMAL DOXORUBICIN IN ASSOCIATION WITH DAILY ORAL CYCLOPHOSPHAMIDE IN METASTATIC BREAST CANCER PATIENTS - I.C.E.-2007

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