Inclusion Criteria:

- Written informed consent must be obtained and documented according to the local
regulatory requirements prior to beginning specific protocol procedures;

- Pathological confirmed primary carcinoma of the breast.

- Locally advanced or metastatic disease

- Up to one previous palliative chemotherapy that did not contain docetaxel or
paclitaxel. Previous adjuvant treatment with taxanes is allowed when the last
application of the taxane was given at least 1 year before entering the trial.

- Patients must have either measurable or non-measurable lesions according to the WHO
criteria

- At least 4 weeks since radiotherapy, with full recovery. The measurable disease must
be completely outside the radiated field or there must be pathological proof of
progressive disease.

- Complete radiological and clinical tumor assessment within 4 weeks prior to
registration performed as clinically indicated

- Karnofsky-Index ≥ 60 %

- Age ≥ 18 years

- Absolute neutrophil count ≥ 1,500 cells/µl, platelets ≥ 100,000/µl, and hemoglobin ≥
9 g/dl

- Bilirubin within normal limits; evaluation of transaminases and alkaline phosphatase
≤ 5x upper normal limit

- Serum creatinine ≤ 2.0 mg/dl

- Normal left ventricular ejection fraction (LVEF) by echocardiogramme

- Patients of childbearing potential, pregnancy test must be negative

- If fertile effective contraception must be used throughout the study

Exclusion Criteria:

- Known or suspected hypersensitivity reaction to the investigational compounds or
incorporated substances;

- Concurrent immunotherapy or hormonal treatment for cancer (Bisphosphonates may be
continued)

- Symptomatic parenchymal brain metastases not responding to treatment

- Life expectancy less than 3 months

- Other serious illness or medical condition that may interfere with the understanding
and giving of informed consent and the conduct of the study

- Concurrent treatment with other experimental drugs or any other anti-cancer therapy
within the last 28 days;

- History of congestive heart failure or other significant uncontrolled cardiac disease

- Pregnant or nursing women