A Multicenter Randomized Trial, With Direct Individual Benefit, to Determine the Optimal Circadian Time of Vinorelbine Administration Combined With Chronomodulated Infusion of 5-Fluorouracil in Previously Treated Patients With Metastatic Breast Cancer

Date de début de l'étude : 1 décembre 1998

DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer At least 1 line of prior chemotherapy for metastatic disease (adjuvant or neoadjuvant chemotherapy is considered first line if completed less than one year prior to palliative chemotherapy) No cerebral metastases Hormonal receptor status: Not specified PATIENT CHARACTERISTICS: Age: Not specified Sex: Female Menopausal status: Not specified Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm ^3 Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.58 mg/dL Cardiovascular: No clinically significant cardiac insufficiency or ischemic disease Pulmonary: No bronchoconstriction other than pulmonary lymphangitis Other: No serious chronic disease No bowel obstruction Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No concurrent prophylactic growth factor Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No prior high-dose chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy No concurrent steroid therapy except in an emergency Radiotherapy: At least 4 weeks since prior radiotherapy (for primary tumor or axillary or mammary chain treatment only) No concurrent radiotherapy Surgery: Not specified Other: No other concurrent antitumor therapy