UFT/LV Maintenance Vs Observation in Metastatic Breast Cancer Responsive to Chemotherapy

Inclusion Criteria: metastatic breast cancer 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 Exclusion Criteria: 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