Inclusion Criteria:

- Women with histologically documented metastatic or locally advanced metastatic
HER2/neu positive breast cancer at 1st line of palliative chemotherapy.

- In the case of previous adjuvant or neoadjuvant chemotherapy with anthracyclines or
taxanes, this must have been completed more than 12 months before inclusion.

- In the case of previous adjuvant or neoadjuvant chemotherapy, cumulative
anthracycline dose ≤ 240 mg/m2 of doxorubicin or 450 mg/m2 of epirubicin or 75 mg/m2
of mitoxantrone on inclusion.

- Previous endocrine therapy is authorized (endocrine therapy other than goserelin must
be stopped before starting treatment).

- Previous radiotherapy is authorized, if discontinued ≥ 4 weeks prior to inclusion in
the study and if < 10% of the bone marrow was within the irradiated area.

- Age ≥ 18 years.

- Performance status 0,1, or 2.

- Life expectancy ≥ 3 months.

- Evaluable disease.

- Normal LVEF (multigated acquisition [MUGA] scan or echocardiography).

- Normal haematological, hepatic and renal parameters: neutrophils ≥ 1.5 x 10^9/l;
platelets ≥ 100 x 10^9/l; hemoglobin (Hb) ≥ 6 mmol/L; total bilirubin ≤ 1.5 times the
upper limit of normal (ULN); transaminases ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5 x
ULN; creatinine ≤ 1.5 x ULN.

- Dated and signed written informed consent.

Exclusion Criteria:

- Previous chemotherapy for metastatic disease.

- History of other cancer, except for cervical carcinoma in situ treated by cone
resection or basal cell or squamous cell skin cancer.

- History of congestive heart failure or myocardial infarction ≤ 1 year; cardiac
function: NYHA ≥ 2 or LVEF < 50%.

- Uncontrolled significant heart disease, such as unstable angina.

- Poorly controlled hypertension.

- Performance status 3, 4.

- Symptomatic or progressive brain metastases.

- Active infection or other serious underlying disease.

- Concomitant participation in other clinical trials.

- Pregnant women or nursing mothers; patients of childbearing potential without
effective contraception.

- Absolute medical contraindication to the use of corticosteroid premedication.

- Allergy to polysorbate 80, doxorubicin, or egg lecithin.

- NCI-CTC grade > 1 peripheral neuropathy.

- Patients not able to comply with regular medical follow-up