Liposomal Doxorubicin, Trastuzumab, and Docetaxel in HER2 Positive Metastatic Breast Cancer

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