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

Inclusion Criteria

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