UFT/LV Maintenance Vs Observation in Metastatic Breast Cancer Responsive to Chemotherapy
NCT ID: NCT00189631
Last Updated: 2005-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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UFT/LV
Observation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Association Européenne de Recherche en Oncologie
OTHER
Principal Investigators
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Jean-Francois Berdah, MD
Role: PRINCIPAL_INVESTIGATOR
AERO
Laurent Zelek, MD
Role: PRINCIPAL_INVESTIGATOR
AERO
Bruno Audhuy, MD
Role: PRINCIPAL_INVESTIGATOR
AERO
Locations
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AERO
Créteil, , France
Countries
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Central Contacts
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Facility Contacts
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Laurent Zelek, MD
Role: primary
Other Identifiers
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AERO-MB02
Identifier Type: -
Identifier Source: org_study_id