Status:
UNKNOWN
UFT/LV Maintenance Vs Observation in Metastatic Breast Cancer Responsive to Chemotherapy
Lead Sponsor:
Association Européenne de Recherche en Oncologie
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00189631
Last Update
December 8 2005
Active Locations (1)
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1
AERO
Créteil, France, 94000