Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy

Inclusion Criteria: * Female patients, age ≥ 18 years * Advanced or metastatic breast cancer, histologically confirmed * Documented HER2 overexpression (IHC 3+ and/or FISH positive) * At least one measurable lesion according to RECIST criteria. Patients with bone-only lesions are not eligible for study entry * Documented disease progression * Patients may have no more than 1 line of palliative treatment, however prior therapies must include trastuzumab in adjuvant or metastatic setting * Life expectancy of at least 12 weeks * Performance status 0-1 * Cardiac ejection fraction \>= 50% as measured by echocardiogram or MUGA scan * Adequate hematology, liver and renal function Exclusion Criteria: * Pregnant or lactating women * Serious medical or psychiatric disorders that would interfere with the patient's safety or informed consent * Severe cardiac disease (uncontrolled angina, arrhythmia, chronic heart failure (CHF) or cardiac disease requiring a device) * Ejection fraction below the institutional normal limit * Maximum cumulative dose of 360 mg/m2 for doxorubicin and 720 mg/m2 for epirubicin * Active bacterial, viral or fungal infection * Patients with clinically apparent brain metastases * Positivity for HIV, Hepatitis B or C * History of other malignancy; patients who have been disease-free for 5 years * Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy) or concurrent treatment with an investigational drug or participation in another clinical trial * Known hypersensitivity to the study drugs Lapatinib and Caelyx or their excipients