UFT/LV Maintenance Vs Observation in Metastatic Breast Cancer Responsive to Chemotherapy

Phase 3

• Conditions: Breast Cancer

• Registration Number: NCT00189631
• Lead Sponsor: Association Européenne de Recherche en Oncologie

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 are overall survival and tolerance. A total of 200 patients will be included.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Last Update Submitted: 2005-12-07
• Last Update Posted: 2005-12-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

AERO; 🇫🇷 Creteil, France