Open label randomized phase III study of weekly docetaxel and docetaxel every 3 weeks in patients with metastatic breast cancer, resistant to prior chemotherapy.

1. Histologically or cytologically proven breast adenocarcinoma;

2. Evaluable or measurable disease according to RECIST criteria;

3. Metastatic progressive breast cancer;

4. No more than 1 line of chemotherapy for metastatic disease;

5. Radiotherapy is allowed, no minimum time interval between the end of radiotherapy and study entry , however the irradiated lesion must not be the only lesion to evaluate response;

6. Performance status ECOG < 2;

7. Adequate liver function defined by:

A. Single abnormalities:

- Total bilirubin < upper normal limit;

- Transaminases < 3.5x upper normal limits;

- Alkaline phosphatase < 6x upper normal limit.

B. Combined abnormalities:

- If transaminase levels are between 1.5x and 3,5 x upper normal limits and Alkaline phosphatase is between 2.5x and 6x upper normal limits, starting dosage should be reduced with 25%;

- NOTE : patients with ASAT/ALAT >3,5 x ULN associated with ALP>6x ULN are not eligible for study.

8. Written informed consent given;

9. Age >18 years.
• Compliance with follow up requirements

1. ECOG > 2;

2. Prior exposure to taxanes for metastatic disease;

3. Patient who received two or more lines of prior chemotherapy for metastatic disease;

4. Inadequate bone marrow function:

A. Neutrophils < 1.5 x 109/L;

B. Platelets <100 x 109/L.

5. Inadequate liver function defined by:

A. Total bilirubin > UNL;

6. Concurrent severe and/or co-morbid medical condition;

7. Concurrent treatment with other experimental drugs or clinical trials;

8. Definite contraindications for the use of corticosteroïds;

9. Pregnant or lactating women;

10. Symptomatic peripheral neuropathy > NCI-CTC grade II;

11. Hormonal treatment (prior hormonal treatment allowed).