UFT/LV Maintenance Vs Observation in Metastatic Breast Cancer Responsive to Chemotherapy
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ClinicalTrials.gov Identifier: NCT00189631
Verified September 2005 by Association Européenne de Recherche en Oncologie. Recruitment status was: Recruiting
To compare maintenance therapy to observation in metastatic breast cancer patients responding (or stabilized) after 1st-line chemotherapy. Main endpoint is disease-free survival. Secondary endpoints are overall survival and tolerance. A total of 200 patients will be included.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
Symptomatic brain metastases
Any uncontrolled severe disease except breast cancer (especially cardiac failure with LVEF < 50% or coronary insufficiency
Other concomitant trial
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