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
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
ClinicalTrials.gov page