Inclusion Criteria:

- Patients with stage IV breast adenocarcinoma, histologically proven by biopsy of the
primary tumor and/or a metastasis.

- Female not pregnant (or with negative pregnancy test) or male.

- Fertile patients must use effective contraception during and for 3 months after drug
administration.

- 18 years or above.

- ECOG performance status 0-1.

- Expected survival longer than three months.

- Resolution of toxicity of prior therapy to grade < 2 (except alopecia).

- With or without prior adjuvant or neoadjuvant chemotherapy (authorized).

- With or without hormone therapy in adjuvant and/or the advanced setting (authorized).

- Evidence of measurable disease as defined by Response Evaluation Criteria in Solid
Tumors (RECIST).

- Biphosphonate therapy must have started at least 4 weeks prior to first dosing of the
study drug.

- Asthma or chronic obstructive pulmonary disease allowed provided daily systemic
corticosteroid therapy is not required.

- Total white cell count ≥ 3.109/L.

- Platelet count ≥ 100.109/L.

- Hemoglobin > 9 g/dL or > 5.58 mmol/L.

- Serum creatinine < 160 µmol/L.

- Total bilirubin < 20 mmol/L, except for familial cholemia (Gilbert's disease).

- Serum ASAT and ALAT < 3 times the upper limit of normal or < 5 times upper limit of
normal if liver metastases are present.

- Able to give written informed consent and to comply with the protocol.

Exclusion Criteria:

- Prior chemotherapy for metastatic breast adenocarcinoma.

- Disease-free interval < 12 months from last dose of adjuvant chemotherapy.

- Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.

- Inflammatory carcinoma.

- Systemic chemotherapy, hormone or endocrine therapy given as breast cancer therapy
within 30 days prior to first dosing of the study drug.

- Any investigational drug within 30 days prior to first dosing of the study drug.

- Candidate for treatment with trastuzumab or administration of trastuzumab within 30
days prior to first dosing of the study drug.

- Known cerebral or leptomeningeal metastases.

- Pregnancy or breast feeding.

- Serious intercurrent infection within the 30 days prior to first dosing of the study
drug.

- Motor or sensory peripheral neuropathy ≥ 2 according to the National Cancer Institute
criteria.

- Congestive heart failure.

- Active acute or chronic infection.

- Active autoimmune disease requiring immunosuppressive therapy.

- Known HIV positivity.

- Life threatening illness unrelated to cancer.

- Previous malignancies within the last two years other than breast carcinoma,
successfully treated squamous cell carcinoma of the skin or in situ carcinoma of the
cervix treated with cone biopsy.

- Previous history of major psychiatric disorder requiring hospitalization or any
current psychiatric disorder that would impede the patient's ability to provide
informed consent or to comply with the protocol.

- Corticosteroids unless used as substitutive therapy or before each injection of
paclitaxel.

- Past history of severe allergic episodes and/or Quincke edema.

- Past or present history of any organic disorder likely to modify absorption,
distribution or elimination of the study drug.

- Alcohol or substance abuse disorder.

- Radiotherapy within the 30 days prior to first dosing of the study drug.