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