objective response or stabilisation after 6 to 8 cycle of a first line chemotherapy
time period between the end of chemotherapy and randomization \< 4 weeks
age over 18 years
Performance status (OMS) \< 2.
Life expectancy \> 3 months
Biological criteria before randomization: Neutrophiles \> 1.5 x 109 G/L; Pl. \> 100 x 109 G/L; Hb \> 10 g/dl; Creatininemia \< 1,5 UNL; Bili. \< 2 UNL; Transaminases \< 2,5 UNL; Alcalines Phosphatases \< 2,5 UNL
Signed written informed consent
You may not be if
Metastatic breast cancer having received more than one chemotherapy line.
Tumor progression under chemotherapy
Free interval between primary tumor and metastases \> 5 years, with estrogen receptors and without visceral metastases
Free interval between primary tumor and metastases \< 18 months after adjuvant chemotherapy if first lime chemotherapy only led to a tumor stabilization
Concomitant hormonotherapy
Other cancer
Symptomatic brain metastases
Any uncontrolled severe disease except breast cancer (especially cardiac failure with LVEF \< 50% or coronary insufficiency
Psychiatric disorder
Other concomitant trial
Male patient
Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential)
History of high dose chemotherapy with bone marrow transplantation
Clareo Health | UFT/LV Maintenance Vs Observation in Metastatic Breast Cancer Responsive to Chemotherapy