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

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

NCT ID: NCT00189631

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Study type: Interventional

Study phase: Phase 3

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: UFT/LV

Intervention type: Procedure
Intervention name: Observation

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:
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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: AERO

Address:
City: Creteil
Zip: 94000
Country: France

Status: Recruiting

Contact:
Last name: Laurent Zelek, MD

Phone: + 33 1 43 77 72 10
Email: laurent.zelek@hmn.aphp.fr

Lead sponsor:
Agency: Association Européenne de Recherche en Oncologie
Agency class: Other

Collaborator:
Agency: Bristol-Myers Squibb
Agency class: Industry

Source: Association Européenne de Recherche en Oncologie

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT00189631