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UFT/LV Maintenance Vs Observation in Metastatic Breast Cancer Responsive to Chemotherapy
Conditions
Breast Cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: UFT/LV
Type: Procedure
Name: Observation
Type: Procedure
Overall Status
Recruiting
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 are overall survival and tolerance. A total of 200 patients will be included.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
- 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
Location
AERO
Creteil, France
Status: Recruiting
Contact: Laurent Zelek, MD - + 33 1 43 77 72 10 - laurent.zelek@hmn.aphp.fr
Sponsors
Association Européenne de Recherche en Oncologie
Source
Association Européenne de Recherche en Oncologie
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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